The Complete Guide To LIMS & Laboratory Informatics - 2015 Edition

The Complete Guide to LIMS
& Laboratory Informatics

2015 Edition
PDF generated using the open source mwlib toolkit. See http://code.pediapress.com/ for more information.
PDF generated at: Mon, 23 Mar 2015 21:18:24 CET
Contents
Articles
1. About the Content of This Guide
LIMSwiki mission
2. Introduction to Informatics in the Laboratory
1
1
2
Information
Informatics (academic field)
Laboratory informatics
3. Informatics Across Several Industries
10
12
Bioinformatics
12
Chemical informatics
18
Environmental informatics
21
Geoinformatics
23
Health informatics
25
4. All about LIMS and LIS
31
Laboratory information management system
31
LIMS feature
37
Laboratory information system
54
LIS feature
57
LIMS and laboratory informatics questionnaire
75
5. More Laboratory Informatics Applications
89
Electronic laboratory notebook
89
Laboratory execution system
92
Scientific data management system
92
Chromatography data management system
93
6. Related Standards and Compliance
95
21 CFR Part 11
95
21 CFR Part 11/Audit guidelines and checklist
97
40 CFR Part 3
103
Good Automated Laboratory Practices
106
Good Automated Manufacturing Practice
107
Health Insurance Portability and Accountability Act
109
Health Insurance Portability and Accountability Act/Audit guidelines and checklist
113
Clinical Laboratory Improvement Amendments
117
Health Level 7
120
ISO 9000
123
ISO/IEC 17025
126
ISO/TS 16949
129
The American Society of Crime Laboratory Directors/Laboratory Accreditation Board
133
The NELAC Institute
134
7. Laboratory Informatics Resources
136
LIMSWiki:LIMSforum and LIMS/LI forum posts
136
Laboratory, Scientific, and Health Informatics Buyer's Guide
183
8. Key Laboratory Informatics Vendors
192
LabLynx, Inc.
192
LABVANTAGE Solutions, Inc.
203
LabWare, Inc.
211
STARLIMS Corporation
217
Thermo Scientific
224
9. Laboratory Informatics Vendor Directory
236
LIMS vendor
236
ELN vendor
248
CDMS vendor
252
LIS vendor
254
SDMS vendor
260
Open-source laboratory informatics software
261
References
Article Sources and Contributors
262
Image Sources, Licenses and Contributors
263
Article Licenses
License
265
1. About the Content of This Guide

LIMSwiki mission
The mission and goal of the 'Laboratory Informatics Encyclopedia', otherwise known as LIMSwiki, is to provide the
laboratory community and LIMS community with an organized, documented, up-to-date, standardized body of
knowledge (BoK) regarding all aspects of laboratory informatics, bioinformatics, and health informatics. The value
and success of LIMSwiki (like any community wiki) is dependent upon the laboratory community contributing their
vast knowledge through the creation of relevant articles and editing of existing articles where knowledge is absent.
The explosion of the laboratory and health informatics fields paired with the vast number of LIMS vendors and
products as well as LIMS' increased scope well beyond its original purpose of sample management to just about
all facets of laboratory operations has resulted in a wealth of information not easily comprehended. This potential
confusion frustrates informatics customers and makes the already challenging task of successfully implementing and
managing a LIMS, ELN, or other informatics software even more difficult. In that regard, the Laboratory Informatics
Institute (which is responsible for this wiki) believes the community (including vendors, users, and consultants) will
benefit from a common vocabulary and understanding to facilitate communication, comparison, and product
integration, providing maximum value to buyers and maximum opportunity to vendors and consultants.
2. Introduction to Informatics in the

Laboratory
Information
Information, in its most restricted technical sense, is a sequence of symbols that can be interpreted as a message,
recorded as signs, or transmitted as signals. Conceptually, information is the message (utterance or expression) being
conveyed. Therefore, in a general sense, information is "knowledge communicated or received concerning a
particular fact or circumstance."
From the stance of information theory, information is taken as a sequence of symbols from an alphabet, say an input
alphabet , and an output alphabet . Information processing consists of an input-output function that maps any input
sequence from into an output sequence from . The mapping may be probabilistic or determinate. It may have
memory or be memoryless.
Information cannot be predicted and resolves uncertainty. The uncertainty of an event is measured by its probability
of occurrence and is inversely proportional to that. The more uncertain an event, the more information is required to
resolve uncertainty of that event. The amount of information is measured in bits. The concept that information is the
message has different meanings in different contexts. Thus the concept of information becomes closely related to
notions of constraint, communication, control, data, form, instruction, knowledge, meaning, understanding,
stimulation, pattern, perception, representation, and entropy.
Variations of information
As sensory input
Often information can be viewed as a type of input to an organism or system. Some inputs are important to the
function of the organism (for example, food) or to the system itself (energy) and are called causal inputs. Other
inputs (information) are important only because they are associated with causal inputs and can be used to predict the
occurrence of a causal input at a later time (and perhaps another place). Some information is important because of its
association with other information, but eventually there must be a connection to a causal input.
In practice, information is usually carried by weak stimuli that must be detected by specialized sensory systems and
amplified by energy inputs before they can be functional to the organism or system. For example, light is often a
causal input to plants but provides information to animals. The colored light reflected from a flower is too weak to
do much photosynthetic work. However, the visual system of the bee detects it, and the bee's nervous system uses
the information to guide the bee to the flower, where the bee often finds nectar or pollen, causal inputs serving a
nutritional function.
As representation and complexity

One theory says information is a concept that involves at least two related entities in order to make quantitative
sense: a dimensionally defined category of objects "S" and any of its subsets "R". In essence "R" is a representation
of "S"; it conveys representational (and hence, conceptual) information about "S". The amount of information that
"R" conveys about "S" is equivalent to the rate of change in the complexity of "S" whenever the objects in "R" are
removed from "S". Under this theory, the universal scientific constructs of pattern, invariance, complexity,
representation, and information are unified under a novel mathematical framework. Among other things, the
Information
framework aims to overcome the limitations of Shannon-Weaver information when attempting to characterize and
measure subjective information.
As an influence which leads to a transformation

Information can also be defined as any type
of pattern that influences the formation or
transformation of other patterns. In this
sense, there is no need for a conscious mind
to perceive, much less appreciate, the
pattern. Consider, for example, DNA. The
sequence of nucleotides is a pattern that
influences the formation and development
of an organism without any need for a
conscious mind.
Systems theory at times seems to refer to
information in this sense, assuming
information does not necessarily involve
any conscious mind, and patterns circulating
(due to feedback) in the system can be
called information. In other words, it can be
said information in this sense is something
potentially perceived as representation,
though not created or presented for that
Visual representation of the relationship between language, data/facts, information,
purpose. For example, anthropologist and
and knowledge
social scientist Gregory Bateson defined
"information" as a "difference that makes a difference."
If, however, the premise of "influence" implies that information has been perceived by a conscious mind and also
interpreted by it, the specific context associated with this interpretation may cause the transformation of the
information into knowledge. Complex definitions of both "information" and "knowledge" make such semantic and
logical analysis difficult, but the condition of "transformation" is an important point in the study of information as it
relates to knowledge, especially in the business discipline of knowledge management. In this practice, tools and
processes are used to assist a knowledge worker in performing research and making decisions, including steps such
as:
reviewing information in order to effectively derive value and meaning

referencing metadata if any is available
establishing a relevant context, often selecting from many possible contexts
deriving new knowledge from the information
making decisions or recommendations from the resulting knowledge
The Danish Dictionary of Information Terms suggests, however, information only provides an answer to a posed
question. Whether the answer provides knowledge depends on the informed person. Thus a generalized definition of
the transformation concept could be "information represents the answer to a specific question."
Information
As a property in physics
Information has had a well-defined meaning in physics. However, in 2003 theoretical physicist J. D. Bekenstein
claimed a growing trend in physics was to define the physical world as being made up of information itself.
Examples of this include the phenomenon of quantum entanglement, where particles can interact without reference
to their separation or the speed of light. Information itself cannot travel faster than light, even if the information is
transmitted indirectly. This could lead to all attempts at physically observing a particle with an "entangled"
relationship to another being slowed down, even though the particles are not connected in any other way other than
by the information they carry.
Another link is demonstrated by the Maxwell's demon thought experiment. In this experiment, a direct relationship
between information and another physical property, entropy, is demonstrated. As a result, destroying the information
is impossible without increasing the entropy of a system; in practical terms this often means generating heat.
As records
Records are specialized forms of information, produced consciously or as by-products of business activities or
transactions and retained because of their value. Organizations value records as evidence of activity, but they may
also be retained for their informational value. Sound records management ensures the integrity of records is
preserved for as long as they are required.
The international standard on records management, ISO 15489, defines records as "information created, received,
and maintained as evidence and information by an organization or person, in pursuance of legal obligations or in the
transaction of business."
The International Committee on Archives (ICA), Committee on Electronic Records defined a record as "recorded
information produced or received in the initiation, conduct, or completion of an institutional or individual activity
and that comprises content, context, and structure sufficient to provide evidence of the activity."
Records may be maintained to retain corporate memory of the organization or to meet legal, fiscal, or accountability
requirements imposed on the organization. In 2005 legal expert Anthony Willis elaborated on this view, stating the
sound management of business records and information delivered "...six key requirements for good corporate
governance ... transparency; accountability; due process; compliance; meeting statutory and common law
requirements; and security of personal and corporate information."
Technologically mediated information

In 2011 scientists Martin Hilbert and Priscila Lpez estimated the world's technological capacity to store information
grew from 2.6 (optimally compressed) exabytes in 1986 which is the informational equivalent to less than one
730-MB CD-ROM per person (539 MB per person) to 295 (optimally compressed) exabytes in 2007. This is the
informational equivalent of almost 61 CD-ROM per person in 2007.
Hilbert and Lpez also stated the world's combined technological capacity to receive information through one-way
broadcast networks was the informational equivalent of 174 newspapers per person per day in 2007., while the
world's combined effective capacity to exchange information through two-way telecommunication networks was the
informational equivalent of six newspapers per person per day.
Information
Information and semiotics

Scientists can also explain information in terms of signs and signal-sign systems. Signs themselves can be considered
in terms of four interdependent levels, layers, or branches of semiotics: pragmatics, semantics, syntax, and empirics.
These four layers serve to connect the social world with the physical or technical. The four branches of semiotics are
described as such:
1. pragmatics: the purpose of communication - Pragmatics links the issue of signs with the context within which
signs are used. The focus of pragmatics is on the intentions of living agents underlying communicative behavior.
In other words, pragmatics links language to action.
2. semantics: the meaning of a message conveyed in a communicative act - Semantics considers the content of
communication, the meaning of signs, and the association between signs and behavior. The study of semantics
links symbols and their referents or concepts, particularly the way in which signs relate to human behavior.
3. syntax: the formalism used to represent a message - Syntax considers the form of communication in terms of the
logic and grammar of sign systems. Syntax focuses on form rather than the content of signs and sign systems.
4. empirics: the signals used to carry a message - Emperics focus on the physical characteristics of the medium of
communication. Empirics is devoted to the study of communication channels and their characteristics, e.g., sound,
light, electronic transmission, etc.
In 2008, lexicographer Sandro Nielsen discussed the relationship between semiotics and information in relation to
dictionaries. The concept of lexicographic information costs is introduced and refers to the efforts users of
dictionaries need to make in order to, first, find the data sought and, secondly, understand the data so they can
generate information.
Communication normally exists within the context of some social situation. The social situation sets the context for
the intentions conveyed (pragmatics) and the form in which communication takes place. We express out intentions
through a mutually understood collection of inter-related signs. Mutual understanding implies agents involved
understand the chosen language in terms of its agreed syntax (syntactics) and semantics. The sender codes the
message in the language and sends the message as signals along some communication channel (empirics). The
chosen communication channel will have inherent properties which determine outcomes such as the speed with
which communication can take place and over what distance.
Further reading
Floridi, Luciano (2010). Information - A Very Short Introduction [1]. Oxford University Press. pp.130. ISBN
[2]
0199551375.
Floridi, Luciano. Zalta, Edward N. ed. Semantic Conceptions of Information [3] (Spring 2013 ed.). Stanford
University.
Frieden, B. Roy (20 August 2012). "Fisher Information, a New Paradigm of Science" [4]. Optical Sciences Center,
Univ. of Arizona.
Von Baeyer, Hans Christian (2004). Information: The New Language of Science [5]. Harvard University Press.
pp.258. ISBN [2]0674013875.
Young, Paul (1987). The Nature of Information [6]. Praeger. pp.192. ISBN [2]0275926982.
Information
External links
Informationsordbogen.dk [7], the Danish Dictionary of Information Terms / Informationsordbogen
Notes
Some elements of this article are reused from the Wikipedia article [8].
References
[1]
[2]
[3]
[4]
[5]
[6]
[7]
[8]
http:/ / books. google. com/ books?id=VupFqa3IJiUC

http:/ / en. wikipedia. org/ wiki/ International_Standard_Book_Number
http:/ / plato. stanford. edu/ entries/ information-semantic/
http:/ / fp. optics. arizona. edu/ frieden/ fisher_information. htm
http:/ / books. google. com/ books?id=QpuZgAR8DJwC
http:/ / books. google. com/ books?id=yX9QAAAAMAAJ
http:/ / www. informationsordbogen. dk
http:/ / en. wikipedia. org/ wiki/ Information

Informatics is the science of information, the practice of
information processing, and the engineering of
information systems. Informatics studies the structure,
algorithms, behavior, and interactions of natural and
artificial systems that store, process, access, and
communicate information. It also develops its own
conceptual and theoretical foundations and utilizes
foundations developed in other fields. Since the advent of
computers, individuals and organizations increasingly
process information digitally. This has led to the study of
informatics that has computational, cognitive, and social
aspects, including study of the social impact of
information technologies.
A computer used at China's 2002 National Olympiad in

Informatics
While the field of informatics encompasses the study of

systems that represent, process, and communicate information, the theory of computation in the specific discipline of
theoretical computer science which evolved from Alan Turing studies the notion of a complex system regardless of
whether information actually exists. Since both fields process information, there is some disagreement among
scientists as to field hierarchy. For example, Arizona State University attempted to adopt a broader definition of
informatics to even encompass cognitive science at the launch of its School of Computing and Informatics in
September 2006.
The confusion arises since information can be easily stored on a computer, and hence informatics could be
considered the parent of computer science. However, the original notion of a computer was the name given to the
action of computation regardless of the existence of information or the existence of a Von Neumann architecture.
Humans are examples of computational systems and not information systems. Many fields such as quantum
computing theory are studied in theoretical computer science but not related to informatics.
A practitioner of informatics may be called an informatician or an informaticist.
Etymology
In 1957 the German computer scientist Karl Steinbuch coined the word Informatik by publishing a paper called
Informatik: Automatische Informationsverarbeitung ("Informatics: Automatic Information Processing"). The English
term informatics is sometimes understood as meaning the same as computer science. However, the German word
Informatik is the correct translation of the English phrase computer science. (The naming for computer science is
derived from the concept of computation, which may or may not involve the existence of information. For example,
quantum computation and digital logic do not involve information.)
The French term informatique was coined in 1962 by Philippe Dreyfus together with various translations
informatics (English), also proposed independently and simultaneously by Walter F. Bauer and associates who
co-founded Informatics Inc., and informatica (Italian, Spanish, Romanian, Portuguese, Dutch), referring to the
application of computers to store and process information. The term was coined as a combination of "information"
and "automatic" to describe the science of automating information interactions.
The morphologyinformat-ion + -icsuses "the accepted form for names of sciences, as conics, linguistics, optics,
or matters of practice, as economics, politics, tactics", and so, linguistically, the meaning extends easily to
encompass both the science of information and the practice of information processing.
History
This new term was adopted across Western Europe, and, except in English, developed a meaning roughly translated
by the English "computer science" or "computing science." Mikhailov et al. advocated the Russian term informatika
(1966), and the English informatics (1967), as names for the theory of scientific information and argued for a broader
meaning, including study of the use of information technology in various communities and of the interaction of
technology and human organizational structures:
Informatics is the discipline of science which investigates the structure and properties (not specific content) of
scientific information, as well as the regularities of scientific information activity, its theory, history,
methodology and organization.
Usage has since modified this definition in three ways. First, the restriction to scientific information is removed, as in
business informatics or legal informatics. Second, since most information is now digitally stored, computation is
now central to informatics. Third, the representation, processing and communication of information are added as
objects of investigation, since they have been recognized as fundamental to any scientific account of information.
Taking information as the central focus of study, then, distinguishes informatics, which includes the study of
biological and social mechanisms of information processing, from computer science, where digital computation
plays a distinguished central role. Similarly, in the study of representation and communication, informatics is
indifferent to the substrate that carries information. For example, it encompasses the study of communication using
gesture, speech and language, as well as digital communications and networking.
The first example of a degree-level qualification in informatics occurred in 1982 when Plymouth Polytechnic (now
the University of Plymouth) offered a four-year BSc (honours) degree in "Computing and Informatics," with an
initial intake of only 35 students. The course still runs today, making it the longest available qualification in the
subject.[citation needed]
In 1989, the first International Olympiad in Informatics (IOI) a competition of the brightest informatics students
around the world was held in Bulgaria. The competition involved two days of intense competition, with up to four
students selected from each participating country to attend and compete for the highest score on a variety of
informatics problems.
Changing definitions
The definition of informatics has seen many variations across different institutions:
The 2008 Research Assessment Exercise, of the U.K. Funding Councils, includes a new Computer Science and
Informatics unit of assessment (UoA), the scope of which is described as follows:
The UoA includes the study of methods for acquiring, storing, processing, communicating and reasoning
about information, and the role of interactivity in natural and artificial systems, through the implementation,
organisation and use of computer hardware, software and other resources. The subjects are characterised by
the rigorous application of analysis, experimentation and design.
At the Indiana University School of Informatics and Computing in Indianapolis and Southeast, informatics is
defined as "the art, science and human dimensions of information technology" and "the study and application of
information technology to the arts, science and professions." These definitions are generally accepted in the
United States and differ from British usage in omitting the study of natural computation.
At the University of California, Irvine, informatics is defined thusly:
Informatics is based on recognizing that the design of this technology is not solely a technical matter, but must
focus on the relationship between the technology and its use in real-world settings. That is, informatics
designs solutions in context, and takes into account the social, cultural and organizational settings in which
computing and information technology will be used.
At the University of Michigan, Ann Arbor, defines it as a "coupling [of] information with computing technology,"
adding:
Informatics provides solid grounding in computer programming, mathematics, and statistics, combined with
study of the ethical and social science aspects of complex information systems. Informatics majors learn to
critically analyze various approaches to processing information and develop skills to design, implement, and
evaluate the next generation of information technology tools.
Applications of informatics
In the English-speaking world the term informatics was first widely used in the applied sense as "medical
informatics," taken to include "the cognitive, information processing, and communication tasks of medical practice,
education, and research, including information science and the technology to support these tasks." Many such
compounds are now in use; they can be viewed as different areas of applied informatics.
In the 2000s, a major area of applied informatics is that of organizational informatics. Organizational informatics is
fundamentally interested in the application of information, information systems and ICT within organizations of
various forms, including private sector, public sector, and voluntary sector organizations. As such, organizational
informatics can be seen to be sub-category of social informatics and a super-category of business informatics.
By 2004, the field of laboratory informatics the specialized application of information technology to optimize and
extend laboratory operations began emerging as a more distinct area of applied informatics.
Contributing disciplines
Computer science
Communication studies
Complex systems
Didactics of informatics
Information science
Information theory
Information technology
Further reading
Gammack, John; Valerie Hobbs; Diarmuid Pigott (2011). The Book of Informatics [1] (1st Revised ed.). Cengage
Learning. pp.548. ISBN [2]0170216004.
Fourman, Michael (2002) (PDF). Informatics: Informatics Research Report EDI-INF-RR-0139 [2]. University of
Edinburgh. pp.9.
Bauer, Walter F. (1996). "Informatics and (et) Informatique" [3]. IEEE Annals of the History of Computing
(Institute of Electrical and Electronics Engineers) 18 (2). Archived from the original [4] on 20 November 2010.
External links
Council of European Professional Informatics Societies (CEPIS) [5]
References
[1]
[2]
[3]
[4]
[5]
http:/ / books. google. com/ books?id=MOIW12eOvJsC

http:/ / www. inf. ed. ac. uk/ publications/ online/ 0139. pdf
http:/ / web. archive. org/ web/ 20101120212846/ http:/ / www. softwarehistory. org/ history/ Bauer1. html
http:/ / www. softwarehistory. org/ history/ Bauer1. html
http:/ / www. cepis. org
10
Laboratory informatics is the specialized application of information
through a platform of instruments, software, and data management
tools that allow scientific data to be captured, migrated, processed, and
interpreted for immediate use, as well as stored, managed, and shared
to support future research, development, and lab testing efforts while
maximizing the efficiency of laboratory operations.
The term "laboratory informatics" has been in use at least since the
early 1980s and has expanded in meaning since then. Before the advent
of computer technology, information management played an important
role in laboratories and research efforts of all sorts. And while today
the process of information management continues to be important,
laboratory informatics tends to focus more on the technology
associated with that information management process.
An Eppendorf thermal cycler as an example of a

laboratory device that measures, processes, and
sends information
The field itself is one which has seen significant growth as demand for
fast and efficient electronic data exchange has boomed. A rapid series of technological developments have made
laboratory equipment less static and more interactive, allowing large networks of integrated lab devices, computers,
and telecommunications equipment to log, analyze, and distribute data. This has progressively enabled scientific
research projects to move from a localized model to a more global model, one that allows "involved researchers to
spend less time collecting data or waiting for information to arrive from another location, which in turn allows them
to focus more on the work at hand and makes their research both faster and more efficient." This has led to
laboratories requiring more robust and scalable data management systems to stay competitive. The rapid rate of
change in the technological and environmental needs of researchers coupled with growing competition has led
to the creation of conferences like the IQPC Forum on Laboratory Informatics to help directors, managers, and
researchers better keep up with the industry.
Sub-elements in laboratory informatics

Laboratory informatics is often modeled as a central component or hub for other branching elements of the field.
However, looking at the architecture in this fashion oversimplifies the field of laboratory informatics and risks giving
the false appearance that branched elements of the field have greater importance than others. Instead, a
multi-layered, non-hierarchical model of these elements that places an emphasis on an individual laboratory's
identified business needs may be more appropriate. A cottage industry of businesses and consultants has developed
from this philosophy, helping laboratories map their informatics needs to their corporate strategy.
Yet it's difficult to deny the existence of branching elements of laboratory informatics. Many scientific pursuits
require a laboratory, from medicine to astrophysics. This has led to special "sub-applications" of informatics to more
specialized laboratories. Genome informatics developed as genetics laboratories sought more efficient ways to
manage the large amounts of data being acquired from experiments and research. As scientists continue their pursuit
of unlocking the secrets of the brain, neuroinformatics and its associated technology has developed to aid those
researchers in their endeavors. And as hydrologists tackle the issues of equitable and efficient use of water for many
different purposes, hydroinformatics and computational hydraulics have emerged.
Technology of laboratory informatics

Important hardware and software systems that play a role in laboratory informatics include but are not limited to:
Chromatography data management systems (CDMS)

Electronic laboratory notebooks (ELN)
Enterprise content management applications (ECM)
Enterprise resource planning applications (ERP)
Laboratory execution systems (LES)
Laboratory information management systems (LIMS)
Laboratory information systems (LIS)
Manufacturing enterprise systems (MES)
Process analytical technology (PAT)
Scientific data management systems (SDMS)
References
11
12
3. Informatics Across Several Industries

Bioinformatics
Bioinformatics is the application of
computer
science
and
information
technology to the field of biology, with a
primary goal of understanding biological
processes. What sets it apart from other
approaches, however, is its focus on
developing and applying computationally
intensive
techniques
(e.g.
pattern
recognition, data mining, machine learning
algorithms, and visualization) to achieve this
goal. Major research efforts in the field
include sequence alignment, gene finding,
genome assembly, drug design, drug
Female laboratory technician sitting at computer that displays a microarray; DNA
discovery, protein structure alignment,
microarray technology aids in gene expression analysis and other bioinformatics
protein structure prediction, prediction of
functions.
gene expression and proteinprotein
interactions, genome-wide association studies, and the modeling of evolution.
The term "bioinformatics" was coined by Paulien Hogeweg and Ben Hesper in 1978 for "the study of informatic
processes in biotic systems." Its primary use since at least the late 1980s has been in genomics and genetics,
particularly in those areas of genomics involving large-scale DNA sequencing. However, rapid developments in
genomic, molecular research, and information technologies have combined to produce a tremendous amount of
information related to molecular and other types of biology. Bioinformatics now entails the creation and
advancement of databases, algorithms, computational, and statistical techniques and theory to solve formal and
practical problems arising from the management and analysis of biological data.
Common activities in bioinformatics include mapping and analyzing DNA and protein sequences, aligning different
DNA and protein sequences to compare them, and creating and viewing 3-D models of protein structures.
History
Arguably one of the first "bioinformatics" projects though the concept didn't yet exist involved the 1965
creation and maintenance of a protein sequence database called the Atlas of Protein Sequence and Structure by
Margaret O. Dayhoff, Richard V. Eck, and Robert S. Ledley. The work grew out of their "biochemical investigation
of the relations between the structures and function of proteins and the theoretical attempt to decipher the genetic
code." Six years later the Brookhaven National Laboratory and the Cambridge Crystallographic Data Centre jointly
created the Protein Data Bank, intended as a public database of three-dimensional protein structures.
The work at Brookhaven would go on to influence others in the field to contribute, with 23 structures contributed in
1976, breaking 5,000 by the end of 1996 and 40,000 in 2006. The significant growth in contributions was fueled by
several events, including: Peter Y. Chou and Gerald D. Fasman's 1974 creation (and later, refinement) of a protein
structure prediction algorithm; David J. Lipman and William R. Pearson's 1985 development (and later, refinement)
Bioinformatics
of FASTP (later FASTA) as well as Stephen Altschul and company's 1990 development and refinement of BLAST,
both database sequence searching algorithms and programs; and the formal start of the Human Genome Project in
1990.
A flurry of genome studies went on to produce unprecedented amounts of biological data, creating a sudden demand
for rapid and efficient computational tools to manage and analyze the data. "The development of these computational
tools depended on knowledge generated from a wide range of disciplines including mathematics, statistics, computer
science, information technology, and molecular biology." The merger of these disciplines largely went on to form
what is now known as bioinformatics.
Bioinformatics vs. computational biology

In order to study how normal cellular activities are altered in different disease states, biological data must be
combined to form a comprehensive picture of these activities. Therefore, the field of bioinformatics has evolved such
that the most pressing task now involves the analysis and interpretation of various types of data, including nucleotide
and amino acid sequences, protein domains, and protein structures. However, the related field of computational
biology differs slightly from bioinformatics. Jin Xiong, author of Essential Bioinformatics, describes the differences
between the two as such:
Bioinformatics is limited to sequence, structural, and functional analysis of genes and genomes and their
corresponding products and is often considered computational molecular biology. However,
computational biology encompasses all biological areas that involve computation. For example,
mathematical modeling of ecosystems, population dynamics, application of the game theory in
behavioral studies, and phylogenetic construction using fossil records all employ computational tools,
but do not necessarily involve biological macromolecules.
Major research areas

Sequence analysis
Since the Phage -X174 was sequenced in 1977, the DNA sequences of thousands of organisms have been decoded
and stored in databases. This sequence information is analyzed to determine genes that encode polypeptides
(proteins), RNA genes, regulatory sequences, structural motifs, and repetitive sequences. A comparison of genes
within a species or between different species can show similarities between protein functions, or relations between
species (the use of molecular systematics to construct phylogenetic trees). With the growing amount of data, it long
ago became impractical to analyze DNA sequences manually. Today, computer programs such as BLAST are used
daily to search sequences from more than 260,000 organisms, containing over 190 billion nucleotides. These
programs can compensate for mutations (exchanged, deleted, or inserted bases) in the DNA sequence, to identify
sequences that are related, but not identical. A variant of this sequence alignment is used in the sequencing process
itself. The so-called shotgun sequencing technique which was used, for example, by The Institute for Genomic
Research to sequence the first bacterial genome, Haemophilus influenzae does not produce entire chromosomes,
but instead generates the sequences of many thousands of small DNA fragments (ranging from 35 to 900 nucleotides
long, depending on the sequencing technology). The ends of these fragments overlap and, when aligned properly by
a genome assembly program, can be used to reconstruct the complete genome. Shotgun sequencing yields sequence
data quickly, but the task of assembling the fragments can be quite complicated for larger genomes. For a genome as
large as the human genome, it may take many days of CPU time on large-memory, multiprocessor computers to
assemble the fragments, and the resulting assembly will usually contain numerous gaps that have to be filled in later.
Shotgun sequencing is the method of choice for virtually all genomes sequenced today, and genome assembly
algorithms are a critical area of bioinformatics research.
13
Bioinformatics
Another aspect of bioinformatics in sequence analysis is annotation, which involves computational gene finding to
search for protein-coding genes, RNA genes, and other functional sequences within a genome. Not all of the
nucleotides within a genome are part of genes. Within the genome of higher organisms, large parts of the DNA do
not serve any obvious purpose. This so-called junk DNA may, however, contain unrecognized functional elements.
Bioinformatics helps to bridge the gap between genome and proteome projects, as in the use of DNA sequences for
protein identification.
Gene expression analysis

The expression of many genes can be determined by measuring mRNA levels with multiple techniques including
microarrays, expressed cDNA sequence tag (EST) sequencing, serial analysis of gene expression (SAGE) tag
sequencing, massively parallel signature sequencing (MPSS), RNA-Seq (also known as "Whole Transcriptome
Shotgun Sequencing" (WTSS)), or various applications of multiplexed in-situ hybridization. All of these techniques
are extremely noise-prone and/or subject to bias in the biological measurement, and a major research area in
computational biology involves developing statistical tools to separate signal from noise in high-throughput gene
expression studies. Such studies are often used to determine the genes implicated in a disorder: one might compare
microarray data from cancerous epithelial cells to data from non-cancerous cells to determine the transcripts that are
up-regulated and down-regulated in a particular population of cancer cells.
Regulation analysis
Regulation is the complex orchestration of events starting with an extracellular signal such as a hormone and leading
to an increase or decrease in the activity of one or more proteins. Bioinformatics techniques have been applied to
explore various steps in this process. For example, promoter analysis involves the identification and study of
sequence motifs in the DNA surrounding the coding region of a gene. These motifs influence the extent to which that
region is transcribed into mRNA. Expression data can be used to infer gene regulation: one might compare
microarray data from a wide variety of states of an organism to form hypotheses about the genes involved in each
state. In a single-cell organism, one might compare stages of the cell cycle, along with various stress conditions (heat
shock, starvation, etc.). One can then apply clustering algorithms to that expression data to determine which genes
are co-expressed. For example, the upstream regions (promoters) of co-expressed genes can be searched for
over-represented regulatory elements.
Protein expression analysis

Protein microarrays and high-throughput mass spectrometry can provide a snapshot of the proteins present in a
biological sample. Bioinformatics is very much involved in making sense of protein microarray and mass
spectrometry data; the former approach faces similar problems as with microarrays targeted at mRNA, the latter
involves the problem of matching large amounts of mass data against predicted masses from protein sequence
databases, and the complicated statistical analysis of samples where multiple, but incomplete peptides from each
protein are detected.
Cancer mutation analysis

In cancer, the genomes of affected cells are rearranged in complex or even unpredictable ways. Massive sequencing
efforts are used to identify previously unknown point mutations in a variety of genes in cancer. Bioinformaticians
continue to produce specialized automated systems to manage the sheer volume of sequence data produced, and they
create new algorithms and software to compare the sequencing results to the growing collection of human genome
sequences and germline polymorphisms. New physical detection technologies are employed, such as oligonucleotide
microarrays to identify chromosomal gains and losses (called comparative genomic hybridization), and
single-nucleotide polymorphism arrays to detect known point mutations. These detection methods simultaneously
14
Bioinformatics
measure several hundred thousand sites throughout the genome, and when used in high-throughput to measure
thousands of samples, generate terabytes of data per experiment. The data is often found to contain considerable
variability, or noise, and thus hidden Markov model and change-point analysis methods are being developed to infer
real copy number changes.
Genome annotation
In the context of genomics, annotation is the process of marking the genes and other biological features in a DNA
sequence. The first genome annotation software system was designed in 1995 by Dr. Owen White, who was part of
the team at The Institute for Genomic Research that sequenced and analyzed the first genome of a free-living
organism to be decoded, the bacterium Haemophilus influenzae. Dr. White built a software system to find the genes
(places in the DNA sequence that encode a protein), the transfer RNA, and other features, and to make initial
assignments of function to those genes. Most current genome annotation systems work similarly, but the programs
available for analysis of genomic DNA are constantly changing and improving.
Comparative and computational genomics

The core of comparative genome analysis is the establishment of the correspondence between genes (orthology
analysis) or other genomic features in different organisms. It is these intergenomic maps that make it possible to
trace the evolutionary processes responsible for the divergence of two genomes. A multitude of evolutionary events
acting at various organizational levels shape genome evolution. At the lowest level, point mutations affect individual
nucleotides. At a higher level, large chromosomal segments undergo duplication, lateral transfer, inversion,
transposition, deletion and insertion. Ultimately, whole genomes are involved in processes of hybridization,
polyploidization and endosymbiosis, often leading to rapid speciation. The complexity of genome evolution poses
many exciting challenges to developers of mathematical models and algorithms, who have recourse to a spectra of
algorithmic, statistical, and mathematical techniques. Examples range from exact, heuristics, fixed-parameter, and
approximation algorithms for problems based on parsimony models to Markov Chain Monte Carlo algorithms for
Bayesian analysis of problems based on probabilistic models.
Biological systems modeling

Systems biology involves the use of computer simulations of cellular subsystems (such as the networks of
metabolites and enzymes which comprise metabolism, signal transduction pathways, and gene regulatory networks)
to both analyze and visualize the complex connections of these cellular processes. Artificial life or virtual evolution
attempts to understand evolutionary processes via the computer simulation of simple (artificial) life forms.
Computational evolutionary biology

Evolutionary biology is the study of the origin and descent of species, as well as their change over time. Informatics
has assisted evolutionary biologists in several key ways, enabling researchers to:
trace the evolution of a large number of organisms by measuring changes in their DNA, rather than through
physical taxonomy or physiological observations alone.
compare entire genomes, which permits the study of more complex evolutionary events, such as gene duplication,
horizontal gene transfer, and the prediction of factors important in bacterial speciation.
build complex computational models of populations to predict the outcome of the system over time.
track and share information on an increasingly large number of species and organisms.
The area of research within computer science that uses genetic algorithms is sometimes confused with computational
evolutionary biology, but the two areas are not necessarily related.
15
Bioinformatics
16
Literature analysis
The sheer amount of published literature makes it virtually impossible to read every paper, resulting in disjointed
subfields of research. Literature analysis aims to employ computational and statistical linguistics to mine this
growing library of text resources. For example:
abbreviation recognition - identify the long-form and abbreviation of biological terms
named entity recognition - recognizing biological terms such as gene names
protein-protein interaction - identify which proteins interact with which proteins from text
The area of research uses statistics and computational linguistics, and is substantially influenced by them.
Structural bioinformatic approaches

Prediction of protein structure
Protein structure prediction is another important
application of bioinformatics. The amino acid
sequence of a protein, the so-called primary
structure, can be easily determined from the sequence
on the gene that codes for it. In the vast majority of
cases, this primary structure uniquely determines a
structure in its native environment. (Of course, there
are exceptions, such as the bovine spongiform
encephalopathy (a.k.a. Mad Cow Disease) prion.)
Knowledge of this structure is vital in understanding
the function of the protein. For lack of better terms,
structural information is usually classified as one of
secondary, tertiary, and quaternary structure. A
viable general solution to such predictions remains
an open problem. As of now, most efforts have been
directed towards heuristics that work most of the
time.
The idealized evolution of a gene lines is shown from a common

ancestor in an ancestral population, descending to three populations
labeled A, B, and C. There are two speciation events, each occurring at
the junctions shown as an upside down Y. There are also two
gene-duplication events, depicted by a horizontal bar.
One of the key ideas in bioinformatics is the notion

of homology. In the genomic branch of bioinformatics, homology is used to predict the function of a gene: if the
sequence of gene A, whose function is known, is homologous to the sequence of gene B, whose function is unknown,
one could infer that B may share A's function. In the structural branch of bioinformatics, homology is used to
determine which parts of a protein are important in structure formation and interaction with other proteins. In a
technique called homology modeling, this information is used to predict the structure of a protein once the structure
of a homologous protein is known. This currently remains the only way to predict protein structures reliably.
One example of this is the similar protein homology between hemoglobin in humans and the hemoglobin in legumes
(leghemoglobin). Both serve the same purpose of transporting oxygen in the organism. Though both of these
proteins have completely different amino acid sequences, their protein structures are virtually identical, which
reflects their near identical purposes.
Bioinformatics
Molecular Interaction
Efficient software is available today for studying interactions among proteins, ligands, and peptides. Types of
interactions most often encountered in the field include proteinligand (including drug), proteinprotein and
proteinpeptide.
Molecular dynamic simulation of movement of atoms about rotatable bonds is the fundamental principle behind
computational algorithms, termed docking algorithms for studying molecular interactions.
Docking algorithms
In the last two decades, tens of thousands of protein three-dimensional structures have been determined by X-ray
crystallography and protein nuclear magnetic resonance spectroscopy (protein NMR). One central question for the
biological scientist is whether it is practical to predict possible proteinprotein interactions only based on these 3D
shapes, without doing proteinprotein interaction experiments. A variety of methods have been developed to tackle
the proteinprotein docking problem, though it seems that there is still much work to be done in this field.
Software and tools

Software tools for bioinformatics range from simple command-line tools to more complex graphical programs and
standalone web-services available from various bioinformatics companies or public institutions.
Open source bioinformatics software

Many free and open-source bioinformatics software tools have existed since the 1980s. The combination of a
continued need for new algorithms for the analysis of emerging types of biological readouts, the potential for
innovative in silico experiments, and freely available open code bases have helped to create opportunities for all
research groups to contribute to both bioinformatics and the range of open-source software available, regardless of
their funding arrangements. In order to maintain this tradition and create further opportunities, the non-profit Open
Bioinformatics Foundation have supported the annual Bioinformatics Open Source Conference (BOSC) since 2000.
Web services in bioinformatics

SOAP and REST-based interfaces have been developed for a wide variety of bioinformatics applications, allowing
an application running on one computer in one part of the world to use algorithms, data, and computing resources on
servers in other parts of the world. The main advantages derive from the fact that end users do not have to deal with
software and database maintenance overheads.
Basic bioinformatics services are classified by the European Bioinformatics Institute (EBI) into numerous categories,
including ontologies, structures, gene expression, proteins, etc. The availability of these service-oriented
bioinformatics resources demonstrate the applicability of web-based bioinformatics solutions, and range from a
collection of standalone tools with a common data format under a single, standalone, or web-based interface, to
integrative, distributed, and extensible bioinformatics workflow management systems.
17
Bioinformatics
18
Further reading
Jones, Neil C.; Pevzner, Pavel A. (2004). An Introduction to Bioinformatics Algorithms [1]. MIT Press. pp.435.
ISBN [2]0262101068.
Lesk, Arthur (2008). Introduction to Bioinformatics [2] (3rd ed.). OUP Oxford. pp.474. ISBN [2]0199208042.
Xiong, Jin (2006). Essential Bioinformatics [3]. Cambridge University Press. pp.339. ISBN [2]113945062X.
External links
The Bioinformatics Organization [4]
Bioinformatics Without Borders [5]
Open Bioinformatics Foundation [6]
Notes
References
[1]
[2]
[3]
[4]
[5]
[6]
[7]
http:/ / books. google. com/ books?id=p_qzpkNVcUwC

http:/ / books. google. com/ books?id=et5qQgAACAAJ
http:/ / books. google. com/ books?id=AFsu7_goA8kC
http:/ / www. bioinformatics. org/
http:/ / www. embnet. org/
http:/ / www. open-bio. org/
http:/ / en. wikipedia. org/ wiki/ Bioinformatics
Chemical
informatics
(more
commonly
known
as
chemoinformatics
and
cheminformatics) is the use of
computer and informational techniques
applied to a range of problems in the
field of chemistry. While the field has
roughly been around around since the
1990s, the rise in high-throughput
screening (a scientific experimentation
method primarily used in drug
discovery)
and
combinatorial
chemistry (a method of synthesizing a
large number of compounds in a single
process), as well as increases in
computing power and data storage
sizes, have increased interest in the
field in the twenty-first century.
The Jmol open-source Java viewer for chemical 3D structures is an example of a software
application that may be used in the field of chemical informatics.
Outside of pharmaceutical research, other applications of chemical informatics include the area of topology,
chemical graph theory, and mining the chemical space. It can also be applied to data analysis for the paper, pulp, and
dye industries.
History
The 1960s saw the introduction of databases for the storage and retrieval of chemical structures, as well as
three-dimensional molecular modeling methods, laying the groundwork for future generations to improve
computational methods of chemical and molecular analysis.
The term "chemoinformatics" was defined by F.K. Brown in 1998 as such:
Chemoinformatics is the mixing of those information resources to transform data into information and
information into knowledge for the intended purpose of making better decisions faster in the area of
drug lead identification and optimization.
Since then, both the "chem" and "chemo" spellings have been used. European academia settled on the term
"chemoinformatics" for its 2006 Obernai research and teaching workshop. Other entities like the Journal of
Cheminformatics and Slovak company Molinspiration have trended towards "cheminformatics."
Application
Storage and retrieval
The primary application of chemical informatics is in the storage and retrieval of both structured and unstructured
information relating to chemical structures, molecular models and other chemical data. Efficiently querying and
retrieving that stored information extends into other realms of computer science like data mining and machine
learning. Other forms of data querying include graph, molecule, sequence, and tree mining.
Representation
The in silico representation of chemical structures uses specialized formats such as the XML-based Chemical
Markup Language or Simplified Molecular-Input Line-Entry System (SMILES) specifications. These representations
are often used for storage in large chemical databases. While some formats are suited for visual representations in
two or three dimensions, others are more suited for studying physical interactions, modeling, and docking studies.
Virtual libraries
Stored chemical data can pertain to both real and virtual molecules. Virtual libraries of such molecules and
compounds may be generated in various ways to explore chemical space and hypothesize novel compounds with
desired properties. The Fragment Optimized Growth (FOG) algorithm, for example, was developed to "grow" novel
classes of compounds like drugs, natural products, and diversity-oriented synthetic products from a training database
of existing compounds.
Virtual screening
In contrast to high-throughput screening, virtual screening involves computationally screening in silico libraries of
compounds, by means of various methods such as docking, to identify members likely to possess desired properties
such as biological activity against a given target. In some cases, combinatorial chemistry is used in the development
of the library to increase the efficiency in mining the chemical space. More commonly, a diverse library of small
molecules or natural products is screened.
19
Quantitative structure-activity relationship (QSAR)

This is the calculation of quantitative structure-activity relationship and quantitative structure property relationship
values, used to predict the activity of compounds from their structures. In this context there is also a strong
relationship to chemometrics, the science of extracting information from chemical systems by data-driven means.
Chemical expert systems are also relevant since they represent parts of chemical knowledge as an in silico
representation.
External links
Cambridge Healthtech Institute Cheminformatics/ Chemoinformatics Glossary & Taxonomy [1]

Indiana Cheminformatics Education Portal [2]
The Blue Obelisk Project [3]
The Chemical Structure Association Trust [4]
The eCheminfo Network and Community of Practice [5]
The UK-QSAR and ChemoInformatics Group [6]
Notes
This article reuses portions of content from the Wikipedia article [7].
References
[1]
[2]
[3]
[4]
[5]
[6]
[7]
http:/ / www. genomicglossaries. com/ content/ chemoinformatics_gloss. asp

http:/ / icep. wikispaces. com/
http:/ / www. blueobelisk. org/
http:/ / www. csa-trust. org
http:/ / www. echeminfo. com/
http:/ / www. ukqsar. org
http:/ / en. wikipedia. org/ wiki/ Cheminformatics
20
Environmental informatics (EI) is a
developing field of science that applies
information processing, management,
and sharing strategies to the
interdisciplinary field of environmental
science. Applications include the
integration of information and
knowledge,
the
application
of
computational
intelligence
to
environmental
data,
and
the
[1]
identification of the environmental
Publicly available data sets and informatics tools like open-source SAGA GIS
enable
impacts of information technology. EI
the creation of environmental models and images such as this.
helps scientists define information
processing requirements, analyze real-world problems, and solve those problems using informatics methodologies
and tools.
As EI has continued to evolve, several other definitions have been offered over the years:
"an emerging field centering around the development of standards and protocols, both technical and institutional,
for sharing and integrating environmental data and information." - Biosphere Data Project, University of
California - Berkeley, 2004
the application of "[r]esearch and system development focusing on the environmental sciences relating to the
creation, collection, storage, processing, modelling, interpretation, display and dissemination of data and
information." - Natural Environment Research Council, 2014
History
Environmental informatics emerged roughly around the late 1980s in Central Europe. For example, in 1986
Germany's Gesellschaft fr Informatik (Society for Computer Science) created the technical committee Informatik
im Umweltschutz (Computer Science in Environmental Protection) dedicated to "the whole spectrum of subjects
related to informatics in environmental protection." The group is still active as of 2014, set to host it's 28th
International Conference on Informatics for Environmental Protection. Since Informatik im Umweltschutz's
inception, other groups there and in other regions of the world were created, including The International
Environmetrics Society (TIES, founded in 1989) and the International Environmental Modelling and Software
Society (iEMSs, founded in 2000), as well as conferences like the International Symposium on Environmental
Software Systems (ISESS, founded in 1995).
21
Application
Environmental informatics can help tackle problems and tasks such as the following:
the acquisition and application of remote sensing data from optical, thermal infrared, and microwave instruments
targeting the atmosphere, vegetation, and the ocean
the estimation of aerosol load in the atmosphere
the gauging of influence of trace gases, aerosol, and clouds on the weather and climate
the analysis of geographical features for urban and regional development
the modeling and assessment of ecological environments
the development and optimization of mathematical algorithms for environmental modeling
Ecoinformatics
Closely related to EI is the concept of ecological informatics or "ecoinformatics," which essentially takes
environmental informatics and adds the consideration of anthropogenic activity trends. Ecoinformatics aims to
facilitate environmental research and management by developing ways to access, manage, and integrate databases of
environmental information and develop new algorithms enabling different environmental datasets to be combined to
test ecological hypotheses.
Further reading
Recknagel, Friedrich; Jrgensen, Sven Erik (ed.); Chon, T. S. (ed.) (2009). "Chapter 3: Ecological Informatics:
Current Scope and Feature Areas" [2]. Handbook of Ecological Modelling and Informatics. WIT Press. pp.4147.
ISBN [2]9781845642075.
Voigt, Kristina (July 2008). "Environmental Informatics, Environmetrics, Chemoinformatics, Chemometrics:
Integration or Separation!?" [3] (PDF). International Congress on Environmental Modelling and Software.
Proceedings of the iEMSs Fourth Biennial Meeting. 3: 15941601. ISBN [2]9788476530740.
External links
Data Observation Network for Earth [4] (DataONE)

ecoinformatics.org - Online Resource for Managing Ecological Data and Information [5]
Ecological Data Wiki [6]
Ecological Informatics: An International Journal on Ecoinformatics and Computational Ecology [7]
Frontiers in Environmental Science - Environmental Informatics [8]
Informatik fr Umweltschutz, Nachhaltige Entwicklung und Risikomanagement [9] (formerly Informatik im
Umweltschutz)
International Environmental Modelling and Software Society [10] (iEMSs)
International Society for Environmental Information Sciences [11] (ISEIS)
Journal of Environmental Informatics [12]
The International Environmetrics Society [13] (TIES)
22
Notes
This article reuses a couple of elements from the Wikipedia article [14].
References
[1] http:/ / saga-gis. org/ en/ index. html
[2] http:/ / books. google. com/ books?id=XzEKlNhnUHUC& pg=PA41
[3] http:/ / www. iemss. org/ iemss2008/ uploads/ Main/ S18-01-Voigt_et_al-IEMSS2008. pdf
[4] http:/ / www. dataone. org
[5] http:/ / www. ecoinformatics. org
[6] http:/ / www. ecologicaldata. org/
[7] http:/ / www. journals. elsevier. com/ ecological-informatics/
[8] http:/ / www. frontiersin. org/ Environmental_Informatics
[9] http:/ / enviroinfo. eu/
[10] http:/ / www. iemss. org/
[11] http:/ / www. iseis. org/
[12] http:/ / www. iseis. org/ jei/
[13] http:/ / www. environmetrics. org/
[14] http:/ / en. wikipedia. org/ wiki/ Environmental_informatics
Geoinformatics
Geoinformatics is a multidisciplinary
field of science that uses technologies
supporting the processes of acquiring,
analyzing, and visualizing geospatial
data.
The
definition
of
the
term
"geoinformatics"
varies
greatly,
however. For example, author G.
Randy Keller, focusing on the internals
of our planet, explained geoinformatics
as the use of "data, software tools, and
computational infrastructure ... to
facilitate studies of the structure,
dynamics, and evolution of the solid
Earth through time, as well as the
Geological scientists use geoinformatics tools to create 3D maps of not only Earth's
processes that act upon it and within it
surface
but also, as in the case of astrogeology, the surface of other planets like Mars.
from the near surface to the core."
Other definitions of geoinformatics
dutifully extend its scope to the surface of the planet, causing more confusion as terms like "geomatics,"
"geographical information system," and "computational geography" are brought to the discussion from different
regions around the world and are often used synonymously. Senior lecturer Ji ma of the University of West
Bohemia in Pilsen attempts to compare "geomatics" and "geoinformatics" using ISO standards:
"According to ISO Standard 19122 'geomatics is a discipline concerned with the collection, distribution,
storage, analysis, processing, presentation of geographic data or geographic information.' Its range is
perfectly described by activities of the Geomatics Canada: establishing and maintainace [sic] of national
spatial reference system, preparing, publishing and distributing of state topographical maps, aeronautical
23
Geoinformatics
charts, aerial photographs and gazetteers, surveys on state boundaries, property surveys on federal lands,
maintainance [sic] of national bases of geographic data for the development of geographical information
systems.
There is no definition of geoinformatics in ISO Standards. One of the best was published by Dietmar
Grnreich, president of the Federal Agency for Cartography and Geodesy in Frankfurt (Main):
'geoinformatics is a discipline concerned with theory of geospatial data modeling, their storage,
management and processing as well as with development of geographical information systems and
necessary information and communication technology.'"
Application
Geoinformatics can help tackle problems and tasks such as the following:
the modeling and use of seismic data

the construction and use of other geologically realistic 3-D models
the production of high-quality paleogeographic maps
the production of astrogeological 3D maps
the measurement of Earth's gravity field
the mitigation of hazards in volcanically active areas
the planning and management of land use

the reconstruction of architecture and archeological sites
the creation of commercial maritime routes
the management of natural resources
Informatics
Scientists practicing in the earth sciences increasingly rely on digital spatial data acquired and visualized from
remotely sensed images analyzed by geographical information systems (GIS). Other informatics tools include
geospatial analysis and modeling software, geospatial databases, and wired and wireless networking technologies.
As these types of systems and tools have become more readily available, a larger global initiative to use them for
greater data integration and sharing has emerged. GEON, for example, is an open collaborative project for creating
infrastructure for collecting 3- and 4D geospatial data. OneGeology is another global informatics initiative
attempting to compile digital geological map data for all to use.
Further reading
Sinha, A. Krishna, et al. (December 2010). "Geoinformatics: Transforming data to knowledge for geosciences"
[1]
. GSA Today 20 (12): 410. doi [2]:10.1130/GSATG85A.1 [3].
External links
GEON [4]
International Cartographic Association [5] (ICA)
International Society for Photogrammetry and Remote Sensing [6] (ISPRS)
International Union of Geodesy and Geophysics [7] (IUGG)
OneGeology [8]
Open Geospatial Consortium [9] (OGC)
24
Geoinformatics
Notes
This article reuses a few elements from the Wikipedia article [10].
References
[1] http:/ / www. geosociety. org/ gsatoday/ archive/ 20/ 12/ article/ i1052-5173-20-12-4. htm
[2] http:/ / en. wikipedia. org/ wiki/ Digital_object_identifier
[3] http:/ / dx. doi. org/ 10. 1130%2FGSATG85A. 1
[4] http:/ / www. geongrid. org/
[5] http:/ / www. icaci. org/
[6] http:/ / www. isprs. org/
[7] http:/ / www. iugg. org/
[8] http:/ / www. onegeology. org/
[9] http:/ / www. opengeospatial. org/
[10] http:/ / en. wikipedia. org/ wiki/ Geoinformatics
Health informatics
Health informatics (also called health
care
informatics,
healthcare
informatics, medical informatics,
nursing
informatics,
clinical
informatics,
or
biomedical
informatics) is a discipline at the
intersection of information science,
computer science, and health care. It
deals with the resources, devices, and
methods required to optimize the
"collection, storage, retrieval, [and]
communication ... of health-related
data, information, and knowledge."
Health informatics is applied to the
areas of nursing, clinical care,
dentistry, pharmacy, public health,
Health informatics helps manage, analyze, and integrate patient data from physician to
occupational therapy, and biomedical
specialist and beyond.
research. Health informatics resources
include not only computers but also
clinical guidelines, formal medical terminologies, and information and communication systems.
Early names for health informatics included medical information data processing, medical information science,
medical informatics, medical computer science, and medical computing.
History
Worldwide use of technology in medicine began in the early 1950s with the rise of computers. In 1949, Gustav
Wager established the first professional organization for informatics in Germany. The prehistory, history, and future
of medical information and health information technology are discussed in reference. Specialized university
departments and Informatics training programs began during the 1960s in France, Germany, Belgium and The
Netherlands. Medical informatics research units began to appear during the 1970s in Poland and in the U.S., with
25
Health informatics
medical informatics conferences springing up as early as 1974. Since then the development of high-quality health
informatics research, education, and infrastructure has been the goal of the U.S. and the European Union.
By the mid-2000s, work in the U.K. by the voluntary registration body the UK Council of Health Informatics
Professions led to the creation of eight key constituencies within the domain of health informatics: information and
communication technologies; health records; information management; knowledge management; health informatics
service and project management; clinical informatics; education, training, and development; and research. Those
constituencies already based on U.K. National Health Service standards (NHS) later found their way into the
NHS' Health Informatics Career Framework in a slightly modified format. As of 2013[1] tens of datasets,
publications, guidelines, specifications, meetings, conferences, and organizations around the world continue to shape
what health informatics is today.
Health informatics in North America

Argentina
Since 1996, the International Medical Informatics Association's Latin America and the Caribbean regional group has
sought to develop health informatics within the region, including Argentina's Asociacin Argentina de Informtica
Mdica (AAIM).
Since 1997, the not-for-profit Buenos Aires Biomedical Informatics Group has represented the interests of a broad
range of clinical and non-clinical professionals working within the health informatics sphere. The group strives to
promote informatics technology and related content within the research and health administration spheres, especially
those relating to the biomedical field.
Brazil
"In 1968 the Pan American Health Organization set up the Regional Library of Medicine and Health Sciences
(BIREME) in the Paulista Medical School in So Paulo under an agreement with the Government of Brazil." The
library also made possible access to the MEDLINE and MEDLARS systems, and it would eventually go on to
become the "hub of the Latin American network of biomedical and health information."
In 1986 the Brazilian Society of Health Informatics (Sociedade Brasileira de Informtica em Sade) was founded to
better expand the use of informatics technology within the country. The same year saw the first Brazilian Congress
of Health Informatics held, and the first Brazilian Journal of Health Informatics was published.
Since 1996, the International Medical Informatics Association's Latin America and the Caribbean regional group has
sought to develop health informatics within the region, including Brazil's Sociedade Brasileira de Informtica em
Sade (SBIS).
Canada
Health Informatics projects in Canada are implemented provincially, with different provinces creating different
systems. A national, federally-funded, not-for-profit organization called Canada Health Infoway was created in 2001
to foster the development and adoption of electronic health records across Canada. As of July 2013[1] there were
380 health informatics projects under way in Canadian hospitals, health-care facilities, pharmacies, and laboratories,
with an investment value of $2.1 billion since its inception.
Provincial and territorial programs include the following:
eHealth Ontario was created as an Ontario provincial government agency in September 2008. It has been
plagued by delays, and its CEO was fired over a multi-million dollar contract scandal in 2009.
Alberta Netcare Portal was created in 2006 by the Government of Alberta. The Netcare portal is used daily by
thousands of clinicians. It provides access to demographic data, prescribed/dispensed drugs, known
allergies/intolerances, immunizations, laboratory test results, diagnostic imaging reports, the diabetes registry and
26
Health informatics
other medical reports. Netcare interface capabilities are being included in electronic medical record products
which are being funded by the provincial government.
United States
Even though the idea of using computers in medicine sprouted as technology advanced in the early twentieth
century, it was not until the 1950s that informatics made a realistic impact in the United States. Robert Ledley led the
charge in the 1950s with his early use of medical computation in his dental projects at the United States National
Bureau of Standards.
By the mid-1950s expert systems such as MYCIN and Internist-I were developed, and the National Library of
Medicine started using even the even more advanced MEDLINE and MEDLARS systems by 1965. Around this
same time a flurry of activity occurred. At the University of Utah, Dr. Homer R. Warner, one of the fathers of
medical informatics, was already offering graduate-level classes in medical computer applications. Meanwhile Neil
Pappalardo, Curtis Marble, and Robert Greenes were developing the Massachusetts General Hospital Utility
Multi-Programming System (MUMPS) in Octo Barnett's Laboratory of Computer Science at Massachusetts General
Hospital in Boston. Yet due to its advanced nature, fragmented use across multiple entities, and inherent difficulty in
extracting and analyzing data from the database, development of healthcare and laboratory systems on MUMPS was
sporadic at best.
By the 1980s, however, the advent of Structured Query Language (SQL), relational database management systems
(RDBMS), and Health Level 7 (HL7) allowed software developers to expand the functionality and interoperability of
health informatics systems, including the application of business analytics and business intelligence techniques to
clinical data. As of 2013[1] web-based and database-centric Internet applications of laboratory informatics software
have further changed the way researchers and technicians interact with data, with web-driven data formatting
technologies like Extensible Markup Language (XML) making interoperability of health and laboratory informatics
software a much-needed reality. SaaS and cloud computing technologies have further changed how informatics
systems are implemented in the U.S and worldwide, while at the same time raising new questions about security and
stability.
Health informatics in Europe

The European Union's Member States are committed to sharing their best practices and experiences to create a
European eHealth Area, thereby improving access to and quality health care at the same time as stimulating growth
in a promising new industrial sector. The associated European eHealth programs plays a fundamental role in the
European Union's strategy. Work on this initiative involves a collaborative approach among several parts of the
Commission services. Additionally, the not-for-profit European Institute for Health Records or EuroRec has
promoted the use of high quality electronic health record systems in the European Union since its foundation in late
2002.
epSOS (European Patients - Smart Open Services) represents another key European initiative to "build and evaluate
a service infrastructure that demonstrates cross-border interoperability between electronic health record systems in
Europe." Co-funded by the European Commission Competitiveness and Innovation Programme since 2008, the
initiative (scheduled to finish on December 31, 2013) was devised with the vision of giving patients in Europe the
opportunity to use cross-border electronic medical record services for healthcare-related activities in participating
epSOS pilot countries.
27
Health informatics
In the United Kingdom
The U.K. health informatics community has long played a key role in international activity, joining Technical
Committee Four (TC 4) of the International Federation of Information Processing in 1968, which eventually became
the International Medical Informatics Association (IMIA) in 1979. In 1978, the Medical Specialist Group of the
British Computer Society organized the first European Federation for Medical Informatics (EFMI) Medical
Informatics Europe (MIE) conference in Cambridge.
In 2002, the idea of a profession of health informatics across the U.K. was first implemented as the U.K. Council for
Health Informatics Professions (UKCHIP), which has a formal Code of Professional Conduct, standards for
expressing competences which are used for entry, confirmation of fitness to practice, re-grading and personal
development. Consistent standards express competences of health informatics professionals in both domain-specific
and generic informatics professional areas. The consistency is intended to apply in operational care delivery
organizations, academia, and the commercial service and solution providers.
The broad history of health informatics in the U.K. has been captured in the 2008 book U.K. Health Computing :
Recollections and Reflections by Glyn M. Hayes and Denise E. Barnett. The book describes the early development
of health informatics in the country as "unorganized and idiosyncratic."
England
In 2002 the National Health Service (NHS) in England contracted several vendors for a national health informatics
system called the National Programme for IT or "NPfIT." By 2010, however, the project drastically behind schedule,
forcing a wide consultation to be launched as part of a wider "Liberating the NHS" plan. "Following three reports on
the National Programme by both the National Audit Office and this Committee, and a review by the Major Projects
Authority, the Government announced in September 2011 that it would dismantle the National Programme but keep
the component parts in place with separate management and accountability structures." The program was officially
dismantled in September 2013, officially dubbed "one of the worst and most expensive contracting fiascos in the
history of the public sector."
Scotland
In 1984, Scotland saw the implementation of the General Practice Administration System (GPASS), developed and
controlled by NHS Scotland. It was provided free to all general practitioners in Scotland. However, an agreement
was reached in 2008 to shut down the electronic system due to "a series of problems and critical reports." The system
was formally shut down in August 2012, with all practices having moved to new systems called EMIS and INPS.
Health informatics in Asia and Oceania

In Asia, Australia, and New Zealand, the regional group called the Asia Pacific Association for Medical Informatics
(APAMI) was established in 1993 and now consists of more than 15 member regions in the Asia Pacific Region.
Australia
Founded in 2002, the Australasian College of Health Informatics (ACHI) is the professional association for health
informatics in the Asia-Pacific region. It represents the interests of a broad range of clinical and non-clinical
professionals working within the health informatics sphere through a commitment to quality, standards, and ethical
practice. ACHI is a sponsor of the e-Journal for Health Informatics, an indexed and peer-reviewed professional
journal. ACHI has also supported the Australian Health Informatics Education Council (AHIEC) since its founding
in 2009.
Although there are a number of health informatics organizations in Australia, the Health Informatics Society of
Australia (HISA) is regarded as the major umbrella group and is a member of the International Medical Informatics
Association (IMIA). Nursing informaticians were the driving force behind the formation of HISA, which is now a
28
Health informatics
company limited by guarantee of the members. The membership comes from across the informatics spectrum that is
from students to corporate affiliates. HISA has a number of branches (Queensland, New South Wales, Victoria and
Western Australia) as well as special interest groups such as nursing (NIA), pathology, aged and community care,
industry, and medical imaging.
China
In Hong Kong a computerized patient record system called the Clinical Management System (CMS) has been
developed by the Hospital Authority since 1994. This system has been deployed at all the sites of the Authority (40
hospitals and 120 clinics) and is used by all 30,000 clinical staff on a daily basis, with a daily transaction of up to 2
millions. The comprehensive records of 7 million patients are available online in the Electronic Patient Record
(ePR), with data integrated from all sites. Since 2004, radiology image viewing has been added to the ePR, with
radiography images from any HA site being available as part of the ePR.
The Hong Kong Hospital Authority placed particular attention to the governance of clinical systems development,
with input from hundreds of clinicians being incorporated through a structured process. The health informatics
section of the Hong Kong Hospital Authority has close relationship with the information technology department and
clinicians to develop healthcare systems for the organization to support the service to all public hospitals and clinics
in the region.
The Hong Kong Society of Medical Informatics (HKSMI) was established in 1987 to promote the use of information
technology in healthcare. The eHealth Consortium has been formed to bring together clinicians from both the private
and public sectors, medical informatics professionals, and the IT industry to further promote IT in healthcare in
Hong Kong.
New Zealand
Health Informatics is taught at five New Zealand universities. The most mature and established is the Otago
program, which has been offered since the mid-1990s. Health Informatics New Zealand (HINZ) is the national
organization that advocates for health informatics. HINZ organizes a conference every year and also publishes the
online journal Healthcare Informatics Review Online.
Health informatics in the Middle East

Saudi Arabia
The Saudi Association for Health Information (SAHI) was established in 2006 to work under direct supervision of
King Saud University for Health Sciences to practice public activities, develop theoretical and applicable knowledge,
and provide scientific and applicable studies.
Regulation and standards

The international standards on the subject are covered by ICS 35.240.80 in which ISO 27799:2008 is one of the core
components.
In the United States

In 2004 the U.S. Department of Health and Human Services (HHS) formed the Office of the National Coordinator
for Health Information Technology (ONCHIT). The mission of this office is widespread adoption of interoperable
electronic health records (EHRs) in the US within 10 years.
The Certification Commission for Healthcare Information Technology (CCHIT), a private nonprofit group, was
funded in 2005 by the U.S. Department of Health and Human Services to develop a set of standards for electronic
health records (EHR) and supporting networks, and certify vendors who meet them. In July, 2006 CCHIT released
29
Health informatics
its first list of 22 certified ambulatory EHR products, in two different announcements.
Clinical Informatics
While health informatics and clinical informatics are often considered the same, some make a distinction between
the two. The American Medical Informatics Association, for example, states clinical informatics is concerned with
the use of information in health care by clinicians. By extension, clinical informaticians analyze, design, implement,
and evaluate information and communication systems that enhance individual and population health outcomes,
improve patient care, and strengthen the clinician-patient relationship.
Clinical informaticians use their knowledge of patient care combined with their understanding of informatics
concepts, methods, and health informatics tools to:
assess information and knowledge needs of health care professionals and patients.
characterize, evaluate, and refine clinical processes.
develop, implement, and refine clinical decision support systems.
lead or participate in the procurement, customization, development, implementation, management, evaluation,
and continuous improvement of clinical information systems.
Clinicians collaborate with other health care and information technology professionals to develop health informatics
tools which promote patient care that is safe, efficient, effective, timely, patient-centered, and equitable.
Further reading
De Moor, Georges J. E. ; McDonald, Clement J.; van Goor, J. M. Noothoven, ed. (1993). Progress in
Standardization in Health Care Informatics [2]. IOS Press. pp.215. ISBN [2]9051991142.
Hovenga, Evelyn J. S., ed. (2010). Health Informatics: An Overview [3]. IOS Press. ISBN [2]1607500922.
Hoyt, Robert E.; Bailey, Nora; Yoshihashi, Ann, ed. (2012). Health Informatics: Practical Guide For Healthcare
And Information Technology Professionals [4]. Lulu Enterprises Incorporated. pp.492. ISBN [2]1105437558.
Smith, Jack (1999). Health Management Information Systems: A Handbook for Decision Makers [5] (2nd ed.).
McGraw-Hill International. pp.348. ISBN [2]0335205658.
Notes
References
[1]
[2]
[3]
[4]
[5]
[6]
http:/ / www. limswiki. org/ index. php?title=Health_informatics& action=edit

http:/ / books. google. com/ books?id=DHzOJaNaOYkC
http:/ / books. google. com/ books?id=eckD3fSrPagC
http:/ / books. google. com/ books?id=6bqruAAACAAJ
http:/ / books. google. com/ books?id=8YjlAAAAQBAJ
http:/ / en. wikipedia. org/ wiki/ Health_informatics
30
31
4. All about LIMS and LIS

Sometimes referred to as a laboratory
information system (LIS) or laboratory
management
system
(LMS),
a
laboratory information management
system (LIMS) is a software-based
laboratory
and
information
management system that offers a set of
key features that support a modern
laboratory's operations. Those key
features include but are not limited
to workflow and data tracking
support, flexible architecture, and
smart data exchange interfaces, which
fully "support its use in regulated
environments." The features and uses
of a LIMS have evolved over the years
Laboratories around the world depend on a LIMS to manage data, assign rights, manage
inventory, and more.
from simple sample tracking to an
enterprise resource planning tool that
manages multiple aspects of laboratory informatics.
Due to the rapid pace at which laboratories and their data management needs shift, the definition of LIMS has
become somewhat controversial. As the needs of the modern laboratory vary widely from lab to lab, what is needed
from a laboratory information management system also shifts. The end result: the definition of a LIMS will shift
based on who you ask and what their vision of the modern lab is. Dr. Alan McLelland of the Institute of
Biochemistry, Royal Infirmary, Glasgow highlighted this problem in the late 1990s by explaining how a LIMS is
perceived by an analyst, a laboratory manager, an information systems manager, and an accountant, "all of them
correct, but each of them limited by the users' own perceptions."
Historically the LIMS, LIS, and process development execution system (PDES) have all performed similar
functions. Historically the term "LIMS" has tended to be used to reference informatics systems targeted for
environmental, research, or commercial analysis such as pharmaceutical or petrochemical work. "LIS" has tended to
be used to reference laboratory informatics systems in the forensics and clinical markets, which often required
special case management tools. The term "PDES" has generally applied to a wider scope, including, for example,
virtual manufacturing techniques, while not necessarily integrating with laboratory equipment.
In recent times LIMS functionality has spread even farther beyond its original purpose of sample management.
Assay data management, data mining, data analysis, and electronic laboratory notebook (ELN) integration are all
features that have been added to many LIMS, enabling the realization of translational medicine completely within a
single software solution. Additionally, the distinction between a LIMS and a LIS has blurred, as many LIMS now
also fully support comprehensive case-centric clinical data.
History of LIMS
Up until the late 1970s, the management of laboratory samples and the associated analysis and reporting were
time-consuming manual processes often riddled with transcription errors. This gave some organizations impetus to
streamline the collection of data and how it was reported. Custom in-house solutions were developed by a few
individual laboratories, while some enterprising entities at the same time sought to develop a more commercial
reporting solution in the form of special instrument-based systems.
In 1982 the first generation of LIMS was introduced in the form of a single centralized minicomputer, which offered
laboratories the first opportunity to utilize automated reporting tools. As the interest in these early LIMS grew,
industry leaders like Gerst Gibbon of the Federal Energy Technology Centre in Pittsburgh began planting the seeds
through LIMS-related conferences. By 1988 the second-generation commercial offerings were tapping into relational
databases to expand LIMS into more application-specific territory, and International LIMS Conferences were in full
swing. As personal computers became more powerful and prominent, a third generation of LIMS emerged in the
early 1990s. These new LIMS took advantage of the developing client/server architecture, allowing laboratories to
implement better data processing and exchanges.
By 1995 the client/server tools had developed to the point of allowing processing of data anywhere on the network.
Web-enabled LIMS were introduced the following year, enabling researchers to extend operations outside the
confines of the laboratory. From 1996 to 2002 additional functionality was included in LIMS, from wireless
networking capabilities and georeferencing of samples, to the adoption of XML standards and the development of
Internet purchasing.
As of 2012, some LIMS have added additional characteristics that continue to shape how a LIMS is defined.
Examples include the addition of clinical functionality, electronic laboratory notebook (ELN) functionality, as well a
rise in the software as a service (SaaS) distribution model.
Technology
Laboratory information management operations
The LIMS is an evolving concept, with new features and functionality being added often. As laboratory demands
change and technological progress continues, the functions of a LIMS will likely also change. Despite these changes,
a LIMS tends to have a base set of functionality that defines it. That functionality can roughly be divided into five
laboratory processing phases, with numerous software functions falling under each:
the reception and log in of a sample and its associated customer data
the assignment, scheduling, and tracking of the sample and the associated analytical workload
the processing and quality control associated with the sample and the utilized equipment and inventory
the storage of data associated with the sample analysis
the inspection, approval, and compilation of the sample data for reporting and/or further analysis
There are several pieces of core functionality associated with these laboratory processing phases that tend to appear
in most LIMS:
32
33
Sample management
The core function of LIMS has traditionally been the
management of samples. This typically is initiated
when a sample is received in the laboratory, at which
point the sample will be registered in the LIMS. This
registration process may involve accessioning the
sample and producing barcodes to affix to the sample
container. Various other parameters such as clinical
or phenotypic information corresponding with the
sample are also often recorded. The LIMS then
tracks chain of custody as well as sample location.
Location tracking usually involves assigning the
sample to a particular freezer location, often down to
the granular level of shelf, rack, box, row, and
column. Other event tracking such as freeze and thaw
cycles that a sample undergoes in the laboratory may
be required.
A lab worker matches blood samples to documents. With a LIMS, this

sort of sample management is made more efficient.
Modern LIMS have implemented extensive configurability, as each laboratory's needs for tracking additional data
points can vary widely. LIMS vendors cannot typically make assumptions about what these data tracking needs are,
and therefore vendors must create LIMS that are adaptable to individual environments. LIMS users may also have
regulatory concerns to comply with such as CLIA, HIPAA, GLP, and FDA specifications, affecting certain aspects
of sample management in a LIMS solution. One key to compliance with many of these standards is audit logging of
all changes to LIMS data, and in some cases a full electronic signature system is required for rigorous tracking of
field-level changes to LIMS data.
Instrument and application integration
Modern LIMS offer an increasing amount of integration with laboratory instruments and applications. A LIMS may
create control files that are "fed" into the instrument and direct its operation on some physical item such as a sample
tube or sample plate. The LIMS may then import instrument results files to extract data for quality control
assessment of the operation on the sample. Access to the instrument data can sometimes be regulated based on chain
of custody assignments or other security features if need be.
Modern LIMS products now also allow for the import and management of raw assay data results. Modern targeted
assays such as qPCR and deep sequencing can produce tens of thousands of data points per sample. Furthermore, in
the case of drug and diagnostic development as many as 12 or more assays may be run for each sample. In order to
track this data, a LIMS solution needs to be adaptable to many different assay formats at both the data layer and
import creation layer, while maintaining a high level of overall performance. Some LIMS products address this by
simply attaching assay data as BLOBs to samples, but this limits the utility of that data in data mining and
downstream analysis.
Electronic data exchange
The exponentially growing volume of data created in laboratories, coupled with increased business demands and
focus on profitability, have pushed LIMS vendors to increase attention to how their LIMS handles electronic data
exchanges. Attention must be paid to how an instrument's input and output data is managed, how remote sample
collection data is imported and exported, and how mobile technology integrates with the LIMS. The successful
transfer of data files in Microsoft Excel and other formats, as well as the import and export of data to Oracle, SQL,
and Microsoft Access databases is a pivotal aspect of a the modern LIMS. In fact, the transition "from proprietary

databases to standardized database management systems such as Oracle ... and SQL" has arguably had one of the
biggest impacts on how data is managed and exchanged in laboratories.
Additional functions
Aside from the key functions of sample management, instrument and application integration, and electronic data
exchange, there are numerous additional operations that can be managed in a LIMS. This includes but is not limited
to:
audit management
fully track and maintain an audit trail
barcode handling
assign one or more data points to a barcode format; read and extract information from a barcode
chain of custody
assign roles and groups that dictate access to specific data records and who is managing them
compliance
follow regulatory standards that affect the laboratory
customer relationship management
handle the demographic information and communications for associated clients
document management
process and convert data to certain formats; manage how documents are distributed and accessed
instrument calibration and maintenance
schedule important maintenance and calibration of lab instruments and keep detailed records of such activities
inventory and equipment management
measure and record inventories of vital supplies and laboratory equipment
manual and electronic data entry
provide fast and reliable interfaces for data to be entered by a human or electronic component
method management
provide one location for all laboratory process and procedure (P&P) and methodology to be housed and
managed
personnel and workload management
organize work schedules, workload assignments, employee demographic information, and financial
information
quality assurance and control
guage and control sample quality, data entry standards, and workflow; reports
create and schedule reports in a specific format; schedule and distribute reports to designated parties
time tracking
claculate and maintain processing and handling times on chemical reactions, workflows, and more
34
LIMS architecture and delivery methods

A LIMS has utilized many architectures and distribution models over the years. As technology has changed, how a
LIMS is installed, managed, and utilized has also changed with it.
The following represents architectures which have been utilized at one point or another:
Thick-client
A thick-client LIMS is a more traditional client/server architecture, with some of the system residing on the
computer or workstation of the user (the client) and the rest on the server. The LIMS software is installed on the
client computer, which does all of the data processing. Later it passes information to the server, which has the
primary purpose of data storage. Most changes, upgrades, and other modifications will happen on the client side.
This was one of the first architectures implemented into a LIMS, having the advantage of providing higher
processing speeds (because processing is done on the client and not the server) and slightly more security (as access
to the server data is limited only to those with client software). Additionally, thick-client systems have also provided
more interactivity and customization, though often at a greater learning curve. The disadvantages of client-side
LIMS include the need for more robust client computers and more time-consuming upgrades, as well as a lack of
base functionality through a web browser. The thick-client LIMS can become web-enabled through an add-on
component.
Thin-client
A thin-client LIMS is a more modern architecture which offers full application functionality accessed through a
device's web browser. The actual LIMS software resides on a server (host) which feeds and processes information
without saving it to the user's hard disk. Any necessary changes, upgrades, and other modifications are handled by
the entity hosting the server-side LIMS software, meaning all end-users see all changes made. To this end, a true
thin-client LIMS will leave no "footprint" on the client's computer, and only the integrity of the web browser need be
maintained by the user. The advantages of this system include significantly lower cost of ownership and fewer
network and client-side maintenance expenses. However, this architecture has the disadvantage of requiring
real-time server access, a need for increased network throughput, and slightly less functionality. A sort of hybrid
architecture that incorporates the features of thin-client browser usage with a thick client installation exists in the
form of a web-based LIMS.
Some LIMS vendors are beginning to rent hosted, thin-client solutions as "software as a service" (SaaS). These
solutions tend to be less configurable than on premise solutions and are therefore considered for less demanding
implementations such as laboratories with few users and limited sample processing volumes.
Another implementation of the thin client architecture is the maintenance, warranty, and support (MSW) agreement.
Pricing levels are typically based on a percentage of the license fee, with a standard level of service for 10 concurrent
users being approximately 10 hours of support and additional customer service, at a roughly $200 per hour rate.
Though some may choose to opt out of an MSW after the first year, it's often more economical to continue the plan
in order to receive updates to the LIMS, giving it a longer life span in the laboratory.
Web-enabled
A web-enabled LIMS architecture is essentially a thick-client architecture with an added web browser component. In
this setup, the client-side software has additional functionality that allows users to interface with the software
through their device's browser. This functionality is typically limited only to certain functions of the web client. The
primary advantage of a web-enabled LIMS is the end-user can access data both on the client side and the server side
of the configuration. As in a thick-client architecture, updates in the software must be propagated to every client
machine. However, the added disadvantages of requiring always-on access to the host server and the need for
cross-platform functionality mean that additional overhead costs may arise.
35

Web-based
Arguably one of the most confusing architectures, web-based LIMS architecture is a hybrid of the thick- and
thin-client architectures. While much of the client-side work is done through a web browser, the LIMS also requires
the additional support of Microsoft's .NET Framework technology installed on the client device. The end result is a
process that is apparent to the end-user through the Microrosoft-compatible web browser, but perhaps not so
apparent as it runs thick-client-like processing in the background. In this case, web-based architecture has the
advantage of providing more functionality through a more friendly web interface. The disadvantages of this setup are
more sunk costs in system administration and support for Internet Explorer and .NET technologies, and reduced
functionality on mobile platforms.
LIMS configurability
LIMS implementations are notorious for often being lengthy and costly. This is due in part to the diversity of
requirements within each lab, but also to the inflexible nature of LIMS products for adapting to these widely varying
requirements. Newer LIMS solutions are beginning to emerge that take advantage of modern techniques in software
design that are inherently more configurable and adaptable particularly at the data layer than prior solutions.
This means not only that implementations are much faster, but also that the costs are lower and the risk of
obsolescence is minimized.
The distinction between a LIMS and a LIS

Up until recently, LIMS and LIS have exhibited a few key differences, making them noticeably separate entities:
1. A LIMS traditionally has been designed to process and report data related to batches of samples from biology labs,
water treatment facilities, drug trials, and other entities that handle complex batches of data. A LIS has been
designed primarily for processing and reporting data related to individual patients in a clinical setting.
2. A LIMS needs to satisfy good manufacturing practice (GMP) and meet the reporting and audit needs of the U.S.
Food and Drug Administration and research scientists in many different industries. A LIS, however, must satisfy the
reporting and auditing needs of hospital accreditation agencies, HIPAA, and other clinical medical practitioners.
3. A LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with
mostly anonymous research-specific laboratory data, whereas a LIS is usually most competitive in patient-centric
settings (dealing with "subjects" and "specimens") and clinical labs.
However, as of 2012 these distinctions have faded somewhat as some LIMS vendors have adopted the case-centric
information management normally reserved for a LIS, blurring the lines between the two components further.
Thermo Scientific's Clinical LIMS is a recent example of this merger of LIMS with LIS, with Dave Champagne,
informatics vice president and general manager, stating: "Routine molecular diagnostics requires a convergence of
the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry
is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results."
STARLIMS Corporation's STARLIMS product is another recent example of this LIMS/LIS merger. With the
distinction between the two entities becoming less clear, discussions within the laboratory informatics community
have raised the question of whether or not the two entities should be considered the same.
36
Standards covered by LIMS

A LIMS covers standards such as:
Title 21 CFR Part 11 from the Food and Drug Administration (United States)
ISO 17025
ISO 15189
Good laboratory practice
LIMS vendors
See the LIMS vendor page for a list of LIMS vendors past and present.
Further reading
Gibbon, G.A. (1996). "A brief history of LIMS" [1] (PDF). Laboratory Automation and Information Management
32 (1): 15. doi [2]:10.1016/1381-141X(95)00024-K [2].
Wood, Simon (September 2007). "Comprehensive Laboratory Informatics: A Multilayer Approach" [3] (PDF).
American Laboratory. p. 1.
References
[1] http:/ / www. sciencedirect. com/ science/ article/ pii/ 1381141X9500024K
[2] http:/ / dx. doi. org/ 10. 1016%2F1381-141X%2895%2900024-K
[3] http:/ / www. starlims. com/ Intl/ AL-Wood-Reprint-9-07. pdf
LIMS feature
You can find a listing of all LIMS vendors and by extension, the features their products offer on the LIMS vendor page.
A LIMS feature is one or more pieces of functionality that appear within a laboratory information management
system (LIMS).
The LIMS is an evolving concept, with new features and abilities being introduced every year. As laboratory
demands change and technological progress continues, the functions of a LIMS will also change. Yet like the
automobile, the LIMS tends to have a base set of functionality that defines it. That functionality can roughly be
divided into five laboratory processing phases, with numerous software functions falling under each:
the reception and log in of a sample and its associated customer data
the assignment, scheduling, and tracking of the sample and the associated analytical workload
the processing and quality control associated with the sample and the utilized equipment and inventory
the storage of data associated with the sample analysis
the inspection, approval, and compilation of the sample data for reporting and/or further analysis
Of course, there are LIMS features that are difficult to categorize under any of these phases. Such features often
contribute to the entire LIMS and how it's utilized. For example, multilingual support appears in LIMS like Assaynet
Inc.'s LIMS2010 and Two Fold Software's Qualoupe LIMS, allowing users to interact with the LIMS in more than
one language. Some functionality may also overlap several laboratory phases, making it difficult to firmly classify.
The features described below come from an analysis of freely available LIMS product information on vendor
websites. An attempt was made to discover the features most utilized in vendors' LIMS products and collect
information on those features for each LIMS. Not every possible feature is referenced here; some LIMS products fill
37
LIMS feature
38
specific niches, utilizing unique functionality to solve a specific problem.

That said, keep in mind the categorization of features below is very loose. It may be viable to argue a feature belongs
under a different section or multiple sections. For the purposes of organizing this information in an uncomplicated
manner, however, some liberty has been taken in the categorizing of features.
Sample, inventory, and data management

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.
Sample login and management

Sample accessioning and management is one of the core functions a modern LIMS is tasked with, whether it's in a
manufacturing, water treatment, or pharmaceutical laboratory. As such, researchers who work in these types of labs
are unable to complete their experiment-based goals without an effective method of managing samples. The process
of sample management for experiments includes, but is not limited to:
storing related sample information, including aliquot numbers, dates, and external links
setting user alerts for sample status
creating and documenting viewable sample container schemas with name and status
assigning sample access rights
assigning custom sample ID numbers based on a specification
Additional functionality that could potentially fall under this feature:
utilizing a unique ID system

barcoding of samples
defining sample points and series
creating data associations for samples - such as pedigree for sample/aliquot relationships or relationships based on
experiment, etc.
issuing sample receipts
Sample tracking
For most laboratory personnel, knowing that a sample has arrived to
the lab isn't good enough; they need to know where it's located and
what is being done with it. Enter the sample tracking feature. Without
it, many problems arise. In the forensic world, for example, many
samples are linked to a criminal investigation. In this case,
misidentification, contamination, or duplication can become significant
issues: a lost sample is essentially missing evidence, while a duplicated
sample can render it useless as evidence.
After sample reception and its initial handling procedures, many LIMS
can then track sample location as well as chain of custody. Location
tracking usually involves assigning the sample to a particular freezer
location, often down to the granular level of shelf, rack, box, row, and
column. The process of tracking a sample has become more
streamlined with increasing support of 2-D barcode technology. While
handwritten labels were the norm, now barcode support in a LIMS can
"tie together a vast amount of information, clearly relating each sample
Where's sample 20110512_122GJH? Sample

tracking functionality will let you know which
lab oven it's in.
LIMS feature
to a specific case." Other event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory
may also be required. As each laboratory's needs for tracking additional data points can vary widely, many modern
LIMS have implemented extensive configurability to compensate for varying environments.
The functionality of sample tracking strongly ties into the audit trail and chain of custody features of a LIMS.
Sample and result batching

What is batching? The United States Environmental Protection Agency (EPA) defines a batch as "a group of samples
which behave similarly with respect to the sampling or testing procedures being employed and which are processed
as a unit." This definition can be applied to many laboratories which handle large quantities of samples for some
form of analysis or processing. A LIMS that has the ability to check in, link, and track groups of samples across one
or multiple facilities is valuable to such laboratories. Additionally, batching the analysis results of multiple samples
or groups of samples gives laboratories more flexibility with how they manage their data. Batching also offers the
benefit of mimicking the production groups of samples while also capturing quality control data for the entire group.
Task and event scheduling

Within the context of a LIMS, the ability to schedule a task or event is a natural extension of how work was done in
a laboratory before the advent of data management systems. Workloads are assigned to technicians, maintenance
schedules are created and followed, and research deadlines must be observed. While these tasks have in the past been
performed without LIMS, a modern data management system can now optimize those tasks and provide additional
scheduling functionality to streamline the operation of a lab. Autoscribe Ltd., for example, offers a scheduling
module for its LIMS that allows users to automatically schedule multiple jobs, data backups, alarms, and reports.
Some LIMS like LabWare, Inc.'s LabWare LIMS offer multiple types of schedulers that match to the particular
functions of a research laboratory. Additional functionality within this feature includes the ability to configure
automated assignments of analysis requests, establish recurring events, and in most cases, create printable schedules.
Examples of tasks and events that can feasibly be scheduled in a LIMS include:
registration of received samples into the system

production of reports
creation and sending of e-mails and alerts
maintenance of equipment
assignment of workloads to personnel
Option for manual result entry

While many LIMS vendors tout the ability of their product to automate the entry of results into the LIMS database,
the need for manual data entry of analysis results still exists. This feature is important to laboratories obtaining
analysis results from multiple sources, including non-digital paper-based results and instruments that can't be
connected to the LIMS. Additional functionality associated with this feature includes a customizable spell check
dictionary and the ability to add comments, notes, and narratives to most anything in the LIMS.
39
LIMS feature
Multiple data viewing methods

Laboratories produce data, and LIMS exist to help manage that data. Additionally, even before the existence of
LIMS, scientists have had a corresponding need for visually representing data. Today a LIMS can not only collect
and analyze data from samples, but it also can represent that data in reports, graphs, gradients, and spreadsheets.
Depending on the LIMS, more than one way to visually represent the data may exist.
Some laboratory information management systems take a very specialized approach to data views. For example,
Biomatters Ltd.'s Geneious and Geneious Pro offer multiple methods of viewing complicated sequence analysis data,
including 3-D structuring and representations of plasmid vectors.
Data and trend analysis

Sample experimentation and analysis plays an
important part of laboratory informatics, helping
laboratories make better sense of their experiments
and reach valuable conclusions about them. While
this important phase of laboratory work has often
been done externally from the LIMS, it's now more
common to see basic analysis tools being included.
Some LIMS allow users to analyze sample data directly from the
software.
Such tools allow raw data to be imported directly to
the LIMS, which then can store, process, and report
information about it. Additionally, calculations and functions used in the analysis are typically definable and editable
for further flexibility.
As with the feature "multiple data viewing methods," data and trend analysis is also increasingly important in
laboratories that have very specialized data management needs. When even in 2009 genetic scientists in large- and
medium-sized sequencing and core centers were voicing concerns about "a lack of adequate vendor-supported
software and laboratory information management systems (LIMS),", today data management options like the
previously mentioned Geneious Pro are starting to emerge, offering the ability to perform specialized analytical tasks
for the sequencing industry.
As sample experimentation and data analysis are important parts of most if not all laboratories, such functionality
which has often come in the form of a separate application or analysis device will likely continue to merge into
LIMS and other data management solutions.
Data and equipment sharing

Aside from data storage and sample registration, a modern LIMS' major contribution to the laboratory is aiding in the
sharing of experiment results, reports, and other data types with those who need it most. Rather than pieces of
information becoming misplaced or forgotten in laboratory notebooks, the LIMS makes it easier to share sample test
results and increase the efficiency of collaboration inside and outside the laboratory. Yet data is more than just
sample test results; it also can come in the form of charts, reports, policy and procedure, and other documents.
Additionally, the need for controlling who has access to those types of data is also an important consideration. As
such, this feature is at least partially tied to other features like document management and configurable security.
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LIMS feature
Customizable fields and/or interface

As thorough as some user interface (UI) developers may be in adding relevant fields and interface options for LIMS
end users, there are at times options that are either omitted or unanticipated. This has traditionally required the end
user to contact the vendor and ask if the needed option(s) can be added in the next release. However, some modern
LIMS vendors have responded instead by adding functionality that gives end users and/or LIMS administrators more
control over the user interface.
Aspects of the LIMS' user interface that are becoming more customizable by the end user include:
system nomenclature
equations used in calculations
data and universal fields
appearance of the interface and/or menus
primary system language
the LIMS source code, especially if in a non-proprietary format
Query capability
As was the case before the advent of databases and
electronic data management solutions, today researchers
must search through sample results, experiment notes,
and other types of data to better draw conclusions about
their research. Whereas this used to mean browsing
through laboratory notebooks, Excel spreadsheets, or
Access databases, now powerful query tools exists within
data management tools like a LIMS. Not only can data be
searched for based on name, number, or vendor, LIMSs
like eBioSys' eLab and Mountain States Consulting's
Advanced query tools allow researchers to better complete project
MSC-LIMS allow for queries of attached meta-data like
objectives.
user ID, project number, task number, sample type,
location, and collection date. Finally, as LIMS continue
to include both sample management and experimental data management functionality, queries become more
powerful in general as now sample and experiment can be matched together in one database.
Query functionality often includes the ability to:
search both transactional data and archived data tables
search multiple databases via an application programming interface (API) or open database connectivity (ODBC)
connection
filter and sort data
create ad-hoc queries
Import data
Data can originate from numerous places in the laboratory. The ability to import that data into a LIMS can be
beneficial, especially when an instrument can't be connected or an external client provides a data feed independent of
the LIMS. Some LIMS like Bridge-Soft's QMS even allow to cross-reference laboratory nomenclature from received
data sources with the recipient's. And of course instrument interfacing allows for even more importation options.
Additional data validation procedures may be applied to the imported data to guarantee information homogeneity.
Additionally, some LIMS may allow for the import and integration of non-normalized legacy data tables with LIMS
data tables into a single database.
41
LIMS feature
Internal file or data linking

This feature allows LIMS users to link together reports, protocols, sample results, and more, providing greater
contextual clarity to projects. Examples include:
linking a sample batch to a test or sample preparation methodology

linking a test process to a particular customer
linking a report to a sample batch
linking a group of test results to a raw data file
linking an image to a work order
linking all lab results with the correct reporting test method
External file or data linking

This feature allows LIMS users to link together data and files in the LIMS with data, files, and customers outside the
scope of the LIMS. Examples include:
linking data files from chromatography equipment to synthesis data
linking equipment ID with an external annotation database
linking external standard operating procedure documents with an internal test specification
ELN support or integration

As a software replacement for more traditional paper laboratory notebooks, the electronic laboratory notebook
(ELN) has been important to laboratory functions. Yet the lines between ELN and LIMS began to blur in the 2000s,
with both types of software incorporating features from the other. The result today is some LIMS either include
traditional ELN functionality or link physical laboratory notebook references to data in the LIMS.
Export to MS Excel
While Microsoft Excel has long been used within the laboratory setting, a slow shift towards relational databases and
LIMS occurred in the late 1990s and early 2000s. Additional concerns with the difficulties of Excel's validation and
compliance with FDA 21 CFR Part 11 and other regulations have led many labs to turn to data management
solutions that are easier to validate. Nevertheless, laboratories continue to use Excel in some fashion, and thus Excel
integration or data exportation in Excel format is a real need for LIMS customers. LIMS with this feature allow raw,
processed, or imported data to be exported in the Excel format for further analysis and dissemination.
Raw data management

While not described as a feature on most LIMS vendor websites, a few indicate that their LIMS is capable of
managing (import, export, editing, etc.) data in its raw format for future analysis.
Data warehouse
A LIMS' data warehouse serves the important function of storing, extracting, and managing the data that laboratories
crank out for the purposes or analysis, reporting, and process management, typically separate from the primary
storage database. Data warehouses also offer the benefit of speeding up queries, making queries and data mining
more user-friendly, and smoothing out data gaps.
42
LIMS feature
Deadline control
Deadline control is functionality within a LIMS that allows users to manage and be notified of events that occur
within the laboratory. With this functionality users can also be notified of upcoming deadlines on anything from
sample analysis to license renewal.
Note that this functionality may also feasibly fall under the task and event scheduling or alarms features. As deadline
control seems to be advertised as a notable feature by only a few vendors, it seems even more likely that this
functionality is considered part of scheduling or alarms.
Production control
There are many types of businesses that produce goods, and in most cases there is a research laboratory involved at
some point in the process. This is especially true in the pharmaceutical and chemical industries, where production
measurements such as yield, volume, activity, and impurity are vital. As LIMSs have already recorded such
information during tests and analysis, the addition of production control functionality seems natural. Some LIMS
take a very active approach to this. For example, 2nd Sight Solutions' OhNo! features production control as major
functionality for the synthesis of radiopharmaceuticals. Other LIMS may have less pronounced production
functionality, while still offering the ability to track the production process in and out of the lab. And yet other
LIMSs like dialog's diaLIMS offer robust production-based functionality but as a module or add-on to the base
LIMS software.
The types of functionality that may fall under this feature include:
recipe management
consumable tracking
batch traceability
production planning
enterprise resource planning
Project and/or task management

Project and task management within a LIMS typically involves the scheduling of tasks to workers and organizing
associated tasks into a more cohesive unit for better tracking and management. While the functionality of task and
event scheduling can also be found in project and task management, many LIMS include functionality beyond
scheduling that warrants the addition of the project and/or task management feature. This functionality includes:
job allocation and rescheduling

instrument workload tracking
time tracking
pending workload verification
priority setting
project-based workflow management
sample, batch, and document linking
work list sharing
recurring event management
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LIMS feature
44
Inventory management
Laboratories use a wide array of inventory, from reagents
to glassware, from radiopharmaceuticals to laboratory
baths. With that comes the need to know how much/many
and the frequency of use. For this, most LIMS products
now include some sort of inventory management
functionality.
register origin, demographics of incoming materials
track used and in-use items via barcodes
track inventory reduction based on usage and shipping
out of the lab
create alerts for when items reach a certain stock level
calculate inventory cost and fluctuation
manage transportation and routing
manual incrementing/decrementing of items
LIMS can help laboratories keep track of their stock of reagents

and even streamline reordering of them.
track location and usage of laboratory equipment

assign storage locations
track forensic evidence
It should be noted that samples and electronic equipment may also be considered inventory, and thus there is likely
some functionality crossover with the sample management and instrument management features.
Document creation and management

Standard operation procedures, (SOPs), specifications, reports, graphs, images, and receipts are all collected and
used in the average laboratory. With a LIMS already designed to manage and store sample and experiment data, it
makes sense to include functionality to create, import, export, and manage other sorts of data files. As sample and
experimental data can be indexed, queried, and linked, so too can document data. Functionality of a typical
document management system includes the ability to:
upload and index documents

enforce version control
provide full text search
export to PDF or other relevant format
add documents as attachments
Case management
The laboratory information system (LIS) has played an important role in the case management tasks of
patient-centric and clinical laboratories. However, some LIMS have gained case management functionality,
effectively blurring the lines between LIS and LIMS.. Self-proclaimed LIMS products have emerged in the clinical,
public health, and veterinary industries, areas that have historically been served by LIS software. When also
considering the fields of law enforcement and forensic science, case management has an increasingly important role
in some LIMS. Functionality seen in the case management feature includes:
case accessioning and assignment

disease tracking
trend analysis
clinical history follow-up
out-of-range result alerts
LIMS feature
45
document and result association

evidence control
study management
Workflow management
Capturing workflow in the lab is becoming more

commonplace for the LIMS.
Workflow management is common in the laboratory, acting as a

graphical representation of planned sequential steps to either fully or
partially automate a process within the lab. Separate standards-based
workflow management systems (in the form of a software component)
have traditionally performed this task. However, in the 2000s LIMS
vendors began incorporating workflow management functionality into
their LIMS software, reducing the headaches that customization of a
LIMS often brought.
Modern commercial and open-source LIMS solutions often feature
workflow management functionality, including:
attribute definition of activities
definition of inputs and outputs of activities

assignment of documentation to activities
setting of quality control limits
dynamically modify workflow in case of future changes
receive notification of changes to the workflow
sending user-defined messages during the process
Specification management
Specification (spec) management is vital to not only the manufacturing and research industries but also to a host of
other laboratories requiring precise measurements and infallible test methods. Just as the ASTM offers standards and
specs for LIMS, so too do LIMS users have standards and specs for their laboratory. With spec management in place
within the LIMS, laboratories can then:
enforce standard operating procedures and business rules

create specs down to a project or sample level
validate recipes and procedures
accept or reject sample batches
document internal and external spec history
Note that some of the functionality of spec management may cross over into the realm of quality control and data
validation.
Customer and supplier management

Unless a laboratory is conducting internalized independent research, in most cases it will do business with external
entities such as contract labs, sample providers, equipment providers, and reagent suppliers. In some cases, even
internal employees may be considered a customer, necessitating documentation of who is using the system and in
what ways. For a veterinary lab, the customer may be the animal and handler. For a forensic lab the customer may be
more complex: internal staff, university staff, police departments, and maintainers of nationwide crime databases
may all at some point act as customers. In these cases, documenting these various points of contact and linking them
to samples, equipment, and tests becomes vital. Managing demographics, complaints, correspondence, and history
LIMS feature
are all feasible with customer management functionality. This process is often made simpler through the use of a
more context-neutral entity creation system, which allows for more flexible management of contacts.
This feature may also be referred to as contact management, an address book module, or a customer service module.
Billing management
While the finances of a laboratory are important, they've typically been handled separately as a business process.
However, some LIMS include additional functionality to make handling financial transactions and documentation of
all sorts possible within the LIMS. In theory, such functionality brings the possibility of keeping more of a
laboratory's data centrally located and queryable. This feature may include:
payment processing
expense reporting
price quotes
revenue management
workload tracking of billable hours
bill of materials
grant management
Quality, security, and compliance

Regulatory compliance
The topic of whether or not a LIMS meets regulatory compliance is often a complex one. While Title 21 CFR Part
11 has arguably had the largest influence on a electronic data management system's compliance, other influential
standards have shaped the way LIMS and other systems handle and store data. Other compliance-based codes,
standards, and regulations include:
ASTM
ASCLD/LAB
Classified data
Freedom of information legislation (various)
GALP and GAMP
HIPAA
Health Level 7
ICD
ISO/IEC 17025
ISO 9000/9001
ISO/TS 16949
ODBC
TNI and NELAP
Title 40 CFR Part 3
With so many codes, standards, and regulations, LIMS consumers are advised to contact vendors with their user
requirements and ask how the vendor's software meets and/or exceeds those requirements.
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LIMS feature
47
QA/QC functions
The quality management functions of a LIMS allow users to maintain a level of necessary quality across many of the
functions in a laboratory. From running quality assurance tests to ensuring employed researchers are proficient at
certain tasks, the QA/QC functionality of a LIMS is largely responsible for the output of consistent data and
manufactured products in and out of the lab.
Common functionality includes:
single or batch QA/QC tests

quality control charts and reports
proficiency testing
document management
instrument maintenance
data acceptance/rejection
certificates of analysis (COA)
data types defined by QC analysis
Performance evaluation
As document management becomes increasingly prevalent in LIMS, it only makes sense to also collate and store all
the documentation associated with employee training and certification. Changes to laboratory techniques, scientific
understanding, and business practices force researchers to learn, reevaluate, and demonstrate competency in order to
maintain quality levels in the laboratory. Evaluations can frequently extend beyond staff members, however. Clinics,
visit types, vendors, or test species can also be tracked and evaluated based on custom criteria. The performance
evaluation functionality of a LIMS makes this possible.
That functionality typically includes the ability to maintain training records and history, and also to link that training
to a technique or piece of equipment. Afterwards, the staff member, vendor, etc. can be marked as competent or
certified in the equipment, knowledge, or process. Periodical assessment of the training and its practical
effectiveness can later be performed. Productivity of an entity or process can also be gauged over a certain date range
based on tracked time, pre-determined milestones, or some other criteria.
Audit trail
As codes and regulations like Title 21 CFR Part 11 mandate "computer
systems (including hardware and software), controls, and attendant
documentation" utilize electronic signatures and audit trails, LIMS
developers must put serious thought into how their software handles
audit trail functionality. The audit trail documentation of the
sequence of activities that have affected an action must be thorough
and seamlessly integrated into the software.
Information recorded in the audit trail typically includes:
Whether validating sample data or an entire
LIMS, maintaining an audit trail is an important
part of 21 CFR Part 11 compliance.
case number
transaction type
amount and quantity prior to change
user notes
operator code
time stamp
location
LIMS feature
Chain of custody
The chain of custody (COC) of an item is of varying importance, depending on the type of laboratory. A highly
regulated laboratory that works under Code of Federal Regulation or other guidelines makes tracking COC a vital
part of its operations. This is especially true in forensic labs, which depend on continuous accountability of their
evidence collection, retention, and disposal procedures. As with an audit trail, a laboratory depends on recorded
information like user ID, time stamp, and location ID to maintain a robust and accurate COC. Barcodes, inventory
management, and configurable security roles all play an important part in maintaining chain of custody.
Configurable roles and security

Many roles exist within the laboratory setting, each with its own set of responsibilities. And just as the role an
individual plays within the laboratory may change, so may the responsibilities associated with each role. This sort of
change necessitates a flexible and configurable security system, one that allows for the placement of individual
LIMS users into standardized security roles which provide role-specific access to certain LIMS functionality.
Additionally, as responsibilities change within roles, that same flexible configuration is necessary for assigning or
restricting access to certain LIMS functionality for each existing or newly created role.
Of course, roles aren't always assigned on an individual level. Often large groups of individuals may need to be
assigned to roles, necessitating group assignments for security purposes. For example, a group of laboratory trainees
may only be given read-only access to the sample login and sample tracking functionality of the system through a
custom "Trainees" group role, while the head researcher of the lab may be given the "Administrator" role, which
allows that individual to access most if not all of the LIMS' functionality.
Data normalization
For the purposes of describing LIMS functionality, "data normalization" specifically refers to the process of ensuring
incoming/imported data into the LIMS is standardized to the same format of existing LIMS data.
Here's an example to better explain this issue. When a LIMS is initially configured, in most if not all cases a clear
standard can be set for how logged samples and their associated measurements pre- and post-analysis are recorded in
the system. Perhaps all temperatures will be recorded in Celsius to two decimal places. If temperature data imported
from a spreadsheet or a lab instrument is not in this format, the LIMS can normalize the incoming data to match the
standard already set for existing LIMS temperature data. This ensures consistency within the LIMS database and
typically leads to better data validation efforts later on.
Note: Some LIMS developers may include data normalization functionality within what they may refer to as data
validation functionality. The line between these two may be blurred or not exist at all.
Data validation
For the purposes of describing LIMS functionality, "data validation" specifically refers to the process of ensuring
existing data in the LIMS either pre-analysis or post-analysis sufficiently meets any number of standards or
thresholds set for sample login, sample analysis, or any other data management process in the LIMS. This validation
process may be completely automatic and system-based, or it may also include additional steps on the part of the
user base utilizing additional LIMS functionality, including verification of standard operating procedures (SOPs),
QC samples, and QA approval.
Note: This functionality shouldn't be confused with the process of validating the LIMS itself, which is an entirely
different process partially falling under regulatory compliance and involves the process of ensuring "the software is
performing in a manner for which it was designed."
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LIMS feature
49
Data encryption
The existence of this functionality in LIMS software generally indicates the LIMS has the ability to protect the
integrity and authenticity of its housed data through the use of a variety of technologies which makes data
unreadable except to those possessing a key/right/etc. to unlock/read the data. This functionality is especially vital to
the Web-enabled LIMS, which transfers information over the Internet in a client-server relationship. As a wide
variety of encryption technologies exist, it's generally a good idea to consult with the developers of a LIMS to
determine the strengths and weaknesses of their employed encryption methods.
Version control
Version control is a form of safeguard which helps preserve data integrity. This is typically done by creating a
modifiable new version of a piece of information rather than allowing the original to be modified. Such versioning
may be applied to a wide variety of digital information housed in the LIMS, including test methods, training
certifications, instrument logs, specifications, and process and procedure (P&P) documentation. In LIMS like
LabWare LIMS, reference data can also be versioned while also retaining the original relationship between samples
and test results, including the version of reference data current at the time lab testing is performed. Information
tracked with such revisions includes attributes like user name, time the edit was made, and what exactly was edited.
This also benefits those managing audit trails and chains of custody.
Other LIMS may employ a different form of version control called file
locking, which simply puts the affected information into a read-only
mode for users while someone else is busy editing it. Another popular
strategy is to, rather than locking the file, allow multiple people edit to
a piece of information, later merging the various edits. Potential LIMS
buyers may need to inquire with developers to determine what type of
versioning scheme is used in the vendor's software.
Automatic data backup
The temperature of an open cryopreservation

container may be monitored on a computer via a
connection to a LIMS with environmental
monitoring functionality.
The existence of this piece of functionality in a LIMS usually means

information contained in one or more associated databases or data
warehouses can be automatically preserved in an additional backup
file. The save location for that file as well as the scheduled backup time is configurable, typically through the
administrative module of the LIMS.
Environmental monitoring
Some LIMS like Core LIMS and Oracle Health Sciences LabPas allow users to monitor the environmental
conditions of not only sample storage containers but also the entire laboratory itself. Attributes like humidity, air
quality, and temperature may be monitored to ensure sample storage units and experiments maintain desired
conditions. Alarms may be able to be configured to notify staff if a storage container's environmental attributes go
beyond a certain threshold. Manufacturers utilizing a LIMS like NOVA-LIMS may also be able to employ more
advanced environmental tracking features in the plant to guarantee a more consistent, higher quality product is
created.
LIMS feature
50
Reporting, barcoding, and printing

Custom reporting
Reporting is a vital part of a LIMS, as it allows users to gain a clearer picture of collected data and potential trends.
At a minimum a number of pre-configured report styles come standard with a LIMS. However, some LIMS are more
flexible than others, offering the ability to customize reports in numerous ways. The most popular attributes of
custom reporting include custom headers, custom information placement, charts, pivot tables, and multiple output
formats.
Note: Some LIMS vendors will offer custom reporting as an option as an added cost, depending on the level of
customization required.
Report printing
Today's LIMS software almost universally offers the ability to print reports and other materials, so this feature may
seem a bit redundant to list. Nonetheless, printer support is a feature worth confirming when considering a piece of
LIMS software.
Label support
The label typically affixed to a sample container is a vital part of the sample tracking process. Identifying
information such as sample number, batch number, and barcodes are printed on such labels to ensure optimized
sample management and more precise sample data. As such, some LIMS allow users to design and print labels
directly from the software.
Barcode support
Barcodes offer many advantages to laboratory techs handling samples,
including more accurate data input, tighter sample/instrument
associations, tighter sample/study associations, and more room for
human-readable information on a label. Given such advantages, many
LIMS developers have integrated barcode support into their laboratory
information management systems, including support for symbologies
like Code 128, Code 39, and Interleaved 2 of 5. Aside from printing
options, a LIMS may also offer support for a variety of bar code
readers.
The word "Wikipedia" encoded in Code 128 and
Code 39
Barcode support and label support are typically found together in

LIMS software, but not always, thus their separation into two features
of a LIMS.
LIMS feature
Export to PDF
A LIMS with this feature is able to collect and save information into a Portable Document Format (PDF).
Export to MS Word
A LIMS with this feature is able to collect and save information into a Microsoft Office Word format.
Export to HTML or XML

A LIMS with this feature is able to collect and save information into a HyperText Markup Language (HTML) and/or
Extensible Markup Language (XML) format.
Fax integration
A LIMS with this feature is able to connect with a fax machine and send information to it via manual input,
automatically, and/or at scheduled intervals.
Email integration
A LIMS with this feature is able to integrate with and use the electronic mail information exchange method to send
reports, alerts, and more via manual input, automatically, and/or at scheduled intervals.
Base functionality
Administrator management
The administrator management tools of a LIMS allow lab technicians to set up the LIMS most optimally for the
laboratory. Through the administrator management interface of a LIMS, other features may be accessed like setting
up user roles and scheduling automatic data backups.
Like report printing, administrator management is nearly ubiquitous in LIMS software, generally considered a
mandatory feature. However, for the purposes of being thorough, it's important to point out its existence.
51
LIMS feature
Modular
This feature indicates that a LIMS has an intentional modular design, which separates some functionality into
manageable components of the overall system. Generally speaking, a modular design allows for 1. the structured
addition of new functionality to a LIMS and 2. the limiting of overall effects on the system design as new
functionality is added.
Instrument interfacing and management

In laboratories there are instruments, and with those
instruments comes scientific measurements which
produce data. It's therefor natural a lab technician
would want to connect those instruments to a
laboratory information management system, which is
already organizing and storing laboratory data. This
sort of interfacing is typically handled with
instrument-to-LIMS interfaces, which started out as
merely data-transfer mechanisms. Later that interface
mechanism became much more robust as a data
management tool, though often at great expense with
heavy involvement from third parties. Today, "many
LIMS vendors can act as single source providers of
An entire room of gas chromatography instruments could potentially be
the entire instrument interfacing solution,", providing
connected to a LIMS via instrument interfacing.
a cheaper and smoother solution to LIMS customers.
The ability to calibrate and schedule maintenance for interfaced instruments may also be included in this category.
Mobile device integration

While not incredibly common, a few LIMS developers are including support for mobile devices in their laboratory
information management system. LabCollector, for example, extends its LIMS' functionality to Pocket PC or
Windows CE devices equipped with wireless barcode scanners, allowing users to read or collect sample information
while on the move. Future Technologies' DNA LIMS, designed for labs performing DNA analysis, has its own
mobile version for technicians who need access but can't be in the lab.
Alarms and/or alerts

Alarms and alerts are an integral part of a LIMS. They can be automatic or scheduled, and they can come in the form
of an e-mail, a pop-up message, or a mobile text message. When the results for a sample analysis go out out of range,
an automatic warning message can appear on the screen of the technician responsible for the analysis. A scheduled
alert can be e-mailed to a lab technician every month indicating a piece of laboratory equipment needs routine
maintenance. If the LIMS is equipped with environmental monitoring, an alert can be sent in the form of an SMS
text message to the head researcher if the temperature inside a freezer unexpectedly rises. All of these scenarios
represent a tiny fraction of the possible implementation of alarms and alerts in a LIMS, highlighting how powerful
(yet easy to take for granted) this feature is.
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LIMS feature
53
Work-related time tracking

This feature specifically refers to a LIMS' ability to track the amount of time an employee spends at work in general
(for payroll purposes) or on more specific projects and tasks (as part of an employee work evaluation program).
Voice recognition system

A LIMS with this feature allows some functions of the LIMS (for example, accessing sample analysis results) to be
accessed via voice commands.
External monitoring
This feature allows clients outside the laboratory to monitor the status of sample batches, test results, and more via
an online Web portal or, less commonly, as activity alerts sent via e-mail, fax, or SMS.
Messaging
The messaging feature of a LIMS may refer to one (or both) of two
things:
a built-in instant messaging system that allows users to converse
with each other through text messages real-time
an SMS text messaging integration that allows the users or the
LIMS itself to send messages or alerts to a user's mobile or smart
phone
Multilingual
If a LIMS is listed as multilingual, its an indication the LIMS interface
can be configured to display more than one language depending on the
preference a user or administrator chooses. Some LIMS interfaces can
only be displayed in one of two languages (English or German, for
example), while others come configured with support for dozens of
languages.
Instant messaging clients built into a LIMS often

make it easier to collaborate.
Network-capable
This feature is perhaps archaic and/or obvious, but it is mentioned nonetheless. It's generally applied to a
non-Web-based LIMS installed over a local or wide-area computer network, essentially indicating the LIMS is not
an isolated application, but rather one that can interface with other instances of the LIMS or other networked
instruments.
Web client or portal

A LIMS with a Web client or portal is either a Web-based LIMS (one that is not installed on every computer, but
rather is hosted on a server and accessed via a Web browser) or a non-Web-based LIMS with an included portal to
access it via the Internet.
LIMS feature
Online or integrated help

This indicates a LIMS has help infrastructure integrated into the software, support documentation via the LIMS
vendor's website, or both.
Software as a service delivery model

This indicates the software can be licensed and utilized via the software as a service (SaaS) delivery model.
Usage-based cost
While rare, some LIMS vendors allow potential clients to license and utilize the vendor's software under a
usage-based cost model. An example of this model in use is Bytewize AB's O3 LimsXpress, which has a cost
directly related to the amount of samples processed each month.
References

A laboratory information system (LIS) is a software
system that records, manages, and stores data for
clinical laboratories. A LIS has traditionally been most
adept at sending laboratory test orders to lab
instruments, tracking those orders, and then recording
the results, typically to a searchable database. The
standard LIS has supported the operations of public
health institutions (like hospitals and clinics) and their
associated labs by managing and reporting critical data
concerning "the status of infection, immunology, and
care and treatment status of patients."
History of LIS
Advances in computational technology in the early
1960s led some to experiment with time and data
management functions in the healthcare setting.
Company Bolt Beranek Newman and the
Massachusetts General Hospital worked together to
create a system that "included time-sharing and
multiuser techniques that would later be essential to the
Hospitals and labs around the world depend on a laboratory
implementation of the modern LIS." At around the
information system to manage and report patient data and test results.
same time General Electric announced plans to
program a hospital information system (HIS), though those plans eventually fell through.
Aside from the Massachusetts General Hospital experiment, the idea of a software system capable of managing time
and data management functions wasn't heavily explored until the late 1960s, primarily because of the lack of proper
technology and of communication between providers and end-users. The development of the Massachusetts General
Hospital Utility Multi-Programming System (MUMPS) in the mid-'60s certainly helped as it suddenly allowed for a
54

multi-user interface and a hierarchical system for persistent storage of data. Yet due to its advanced nature,
fragmented use across multiple entities, and inherent difficulty in extracting and analyzing data from the database,
development of healthcare and laboratory systems on MUMPS was sporadic at best. By the 1980s, however, the
advent of Structured Query Language (SQL), relational database management systems (RDBMS), and Health Level
7 (HL7) allowed software developers to expand the functionality and interoperability of the LIS, including the
application of business analytics and business intelligence techniques to clinical data.
Today, web-based and database-centric Internet applications of laboratory informatics software have changed the
way researchers and technicians interact with data, with web-driven data formatting technologies like Extensible
Markup Language (XML) making LIS and EMR interoperability a much-needed reality. SaaS and cloud computing
technologies have further changed how the LIS is implemented, while at the same time raising new questions about
security and stability.
Common LIS functions

Functions that a LIS has historically performed include, but are not limited to:
patient management, including admission date, admitting physician, ordering department, specimen type, etc.
patient data tracking
decision support, including comparisons of lab orders with their respective ICD-9 codes
test ordering
quality assurance
workload and management reporting
workflow management
billing
Clinical vs. anatomic pathology LIS

The laboratory information system has been primarily segmented into two broad categories (though other variations
exist): the clinical pathology and anatomic pathology LIS.
In clinical pathology the chemical, hormonal, and biochemical components of body fluids are analyzed and
interpreted to determine if a disease is present, while anatomic pathology tends to focus on the analysis and
interpretation of a wide variety of tissue structures, from small slivers via biopsy to complete organs from a surgery
or autopsy. These differences may appear to be small, but the differentiation in laboratory workflow of these two
medical specialties has led to the creation of different functionalities within LISs. Specimen collection, receipt, and
tracking; work distribution; and report generation may vary sometimes significantly between the two types of
labs, requiring targeted functionality in the LIS. Other differences include:
Specific dictionary-driven tests are found in clinical pathology environments but not so much in anatomic
pathology environments.
Ordered anatomic pathology tests typically require more information than clinical pathology tests.
A single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology
orders usually do not.
Anatomic pathology specimen collection may be a very procedural, multi-step processes, while clinical pathology
specimen collection is routinely more simple.
55
Differences between a LIS and LIMS

There is often confusion regarding the difference between a laboratory information system (LIS) and a laboratory
information management system (LIMS). While the two laboratory informatics components are related, their
purposes diverged early in their existences. Up until recently, LIMS and LIS have exhibited a few key differences:
1. A LIS has been designed primarily for processing and reporting data related to individual patients in a clinical
setting. A LIMS has traditionally been designed to process and report data related to batches of samples from drug
trials, water treatment facilities, and other entities that handle complex batches of data.
2. A LIS must satisfy the reporting and auditing needs of hospital accreditation agencies, HIPAA, and other clinical
medical practitioners. A LIMS, however, needs to satisfy good manufacturing practice (GMP) and meet the
reporting and audit needs of the U.S. Food and Drug Administration and research scientists in many different
industries.
3. A LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and
clinical labs, whereas a LIMS is most competitive in group-centric settings (dealing with "batches" and "samples")
that often deal with mostly anonymous research-specific laboratory data.
However, as of 2011 these distinctions have faded somewhat as some LIMS vendors have adopted the case-centric
information management normally reserved for a LIS, blurring the lines between the two components further.
LIS vendors
See the LIS vendor page for a list of LIS vendors past and present.
Further reading
Henricks, Walter H. (09 October 2012). "LIS Basics: CP and AP LIS Design and Operations" [1] (PDF).
Pathology Informatics 2012. Walter H. Henricks, MD.
Park, Seung Lyung; Pantanowitz, Liron; Sharma, Guarav; Parwani, Anil Vasdev (March 2012). "Anatomic
Pathology Laboratory Information Systems: A Review" [2]. Advances in Anatomic Pathology 19 (2): 8196. doi
[2]
:10.1097/PAP.0b013e318248b787 [3]. (Alternate URL [4])
References
[1]
[2]
[3]
[4]
http:/ / www. pathinformatics. pitt. edu/ sites/ default/ files/ 2012Powerpoints/ 01HenricksTues. pdf
http:/ / ebookbrowse. com/ anatomic-pathology-laboratory-information-systems-a-review-slpark-et-all-adv-anat-pathol-2012-pdf-d344405134
http:/ / dx. doi. org/ 10. 1097%2FPAP. 0b013e318248b787
https:/ / docs. google. com/ gview?url=http:/ / bpa-pathology. com/ uploads/ file/ docs/ Anatomic+ Pathology+ Laboratory+ Information+
Systems+ -+ A+ Review+ -+ SLPark+ et+ all. + -+ Adv+ Anat+ Pathol+ 2012. pdf& chrome=true
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LIS feature
57
LIS feature
You can find a listing of all LIS vendors and by extension, the features their products offer on the LIS vendor page.
A LIS feature is one or more pieces of

functionality that appear within a laboratory
information system (LIS).
The LIS has traditionally been utilized in
clinical, pathology, and medical research
laboratories as well as numerous public
health institutions. Yet as laboratory
demands have changed and technological
progress has continued, the functions of a
LIS have also changed, with the distinction
between a LIS and a laboratory information
management system (LIMS) fading as some
LIMS vendors have adopted the case-centric
information management normally reserved
for a LIS..
Thousands of hospital laboratories like this one benefit from the use of a laboratory
information system.
Despite the blurring of distinction between a

LIS and a LIMS, the LIS generally continues to feature the following:
patient management, including admission date, admitting physician, ordering department, specimen type, etc.
patient data tracking
decision support, including comparisons of lab orders with their respective ICD codes
quality assurance of ordered tests
workload and management reporting
Of course, there are LIS features that are difficult to categorize or simply contribute to the whole of the LIS rather
than add a function. For example, multilingual support allows users to interact with the LIS in more than one
language. Some functionality may also overlap several research phases, making it difficult to firmly classify.
The features described below come from an analysis of freely available LIS product information on vendor websites.
An attempt was made to discover the features most utilized in vendors' LIS products and collect information on those
features for each LIS. Not every possible feature is referenced here; some LIS products fill specific niches, utilizing
unique functionality to solve a specific problem.
That said, keep in mind the categorization of features below is very loose. It may be viable to argue a feature belongs
under a different section or multiple sections. For the purposes of organizing this information in an uncomplicated
manner, however, some liberty has been taken in the categorizing of features.
LIS feature
Experiment, patient, and data management

Sample login and management

Sample login and management often referred to as accessioning or specimen management is an important
component of the clinical laboratory, whether it's a molecular pathology lab testing samples for disease indicators or
a contract lab running pharmacokinetic and biomarker analysis on samples from a clinical trial. As such, researchers
and technicians who work in these types of labs are unable to complete their tasks without an effective method of
managing samples. The process of sample management and accessioning includes, but is not limited to:
storing related sample information, including demographics, dates, and external links
creating and documenting viewable sample container schemas with name and status
assigning sample access rights
assigning custom sample ID or accessioning numbers based on a specification
applying additional processing to the sample before storage and/or analysis
Additional functionality that could potentially fall under this feature:

barcoding or RFID tagging of samples
defining sample points and series
creating data associations for samples - such as pedigree for sample/aliquot relationships or relationships based on
experiment, etc.
issuing sample receipts
Sample tracking
For most laboratory personnel, knowing that a sample has arrived to
the lab isn't good enough; they need to know where it's located and
what is being done with it. Enter the sample tracking feature. Without
it, many problems arise. In the forensic world, for example, many
samples are linked to a criminal investigation. In this case,
misidentification, contamination, or duplication can become significant
issues: a lost sample is essentially missing evidence, while a duplicated
sample can render it useless as evidence.
After sample reception and its initial handling procedures, many LIS
can then track sample location as well as chain of custody. Location
tracking usually involves assigning the sample to a particular freezer,
oven, or other location, often down to the granular level of shelf, rack,
box, row, and column. The process of tracking a sample has become
more streamlined with increasing support of 2-D barcode or
radio-frequency identification (RFID) technology. While handwritten
labels were the norm, now barcode and RDIF support in a LIS can "tie
together a vast amount of information, clearly relating each sample to a
Where's sample 20110512_122GJH? Sample
specific case." Other event tracking such as freeze and thaw cycles that
tracking functionality will let you know which
a sample undergoes in the laboratory may also be required. As each
lab oven it's in.
laboratory's needs for tracking additional data points can vary widely,
many modern LIMS and LIS have implemented extensive configurability to compensate for varying environments.
The functionality of sample tracking strongly ties into the audit trail and chain of custody features of a LIS.
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LIS feature
Sample and result batching

What is batching? The United States Environmental Protection Agency (EPA) defines a batch as "a group of samples
which behave similarly with respect to the sampling or testing procedures being employed and which are processed
as a unit." This definition can be applied to many laboratories which handle large quantities of samples for some
form of analysis or processing. A LIS that has the ability to check in, link, and track groups of samples across one or
multiple facilities is valuable to such laboratories. Additionally, batching the analysis results of multiple samples or
groups of samples gives laboratories more flexibility with how they manage their data. Batching also offers the
benefit of mimicking the production groups of samples while also capturing quality control data for the entire group.
Task and event scheduling

Within the context of a LIS, the ability to schedule a task or event is a natural extension of how work was done in a
laboratory before the advent of data management systems. Sample processing, data analysis, equipment
maintenance, and case management follow-ups are assigned to technicians and other personnel. Outpatient
scheduling is another aspect of some clinical atmospheres, better handled with computerized scheduling
functionality. While these tasks have in the past been performed without the LIS, a modern data management system
can now optimize those tasks and provide additional scheduling functionality to streamline the operation of a lab.
Some LISs like Elekta AB's IntelliLab include a scheduling calendar for recurring test orders, rules-based orders, and
pre-defined selection lists. Additional functionality within this feature group includes the ability to configure
automated assignments of experiment requests, establish recurring events, and in most cases, create printable reports.
Examples of tasks and events that can feasibly be scheduled in a LIS include:
production of reports
creation and sending of e-mails and alerts
maintenance of equipment
assignment of accessioning tasks to technicians
scheduling outpatient visits
Option for manual result entry

While many LIS vendors tout the ability of their product to automate the entry of sample analysis results into LIS' or
other databases, the need for manual data entry of analysis results still exists. This feature is important to laboratories
obtaining analysis results from multiple sources, including non-digital paper-based results and instruments that can't
be connected to the LIS. Additional functionality associated with this feature includes a customizable spell-check
dictionary and the ability to add comments, notes, and narratives to many of the data items in the LIS.
Multiple data viewing methods

Hospitals, physicians, and clinical research facilities produce reams of data, and the LIS exists to help organize and
distribute that data to the necessary entities. Additionally, even before the existence of the LIS, scientists have had a
corresponding need for visually representing that data for clearer analysis and hypothesis creation. Today a LIS can
not only collect and analyze data, but it also can represent that data in reports, graphs, gradients, and spreadsheets.
Depending on the LIS, more than one way to visually represent the data may exist.
This category ties in with the custom templates and forms functionality apparent in some LIS, providing both custom
and standardized ways to present information across a healthcare or medical research enterprise.
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LIS feature
Configurable templates and forms

Similar to an electronic laboratory notebook (ELN), a template in a LIS is a functionality item which allows users to
increase the productivity and quality of their work by allowing for the creation of a standardized analysis page,
patient page, or reporting process across a healthcare or medical research enterprise. These templates allow
researchers to maintain more consistent data representation for similar tasks in the LIS and save time by not needing
to manually input common data outputs or recreate experiments. Templates and forms typically utilize a wide field
library, and the data that is posted to those template fields can also be normalized to a specific standard. Types of
templates that may be created include those for renal and blood pressure analysis, patient demographics, test
ordering, and department-level reports.
Data and trend analysis

For public health centers and pharmaceutical
research centers alike, data analysis plays an
important role in their operations, helping clinicians
and researchers make better sense of their collected
data and reach valuable conclusions about them.
While this important phase of laboratory work has
often been done externally from the LIS, it's now
Some LISs allow users to analyze patient test results or clinical research
data with built-in software tools.
more common to see basic analysis tools being
included. Such tools allow raw data to be imported
directly to the LIS, which then can store, process, and display it in a shareable form. Vendors may include data
analysis functionality by simply including Microsoft Excel compatibility or providing advanced reporting tools, or
they may take a more advanced approach by programming and including their own custom data and trend analysis
tools in their informatics software. As sample analysis is increasingly an important part of most if not all
laboratories, such functionality which has often come in the form of a separate application or analysis device
will likely continue to merge into software like LIS, LIMS, and other laboratory informatics solutions.
Data and equipment sharing

Aside from data storage and sample registration, a modern LIS's major contribution to the laboratory is aiding in the
sharing of test results, reports, and patient data with other entities across the clinical and research enterprise. Rather
than pieces of information becoming misplaced or locked away in a physician's office or pathology lab, the LIS
makes it easier to test results and increase the efficiency of patient-doctor-lab collaboration in general. Yet data is
more than just test results; it also can come in the form of charts, reports, policy and procedure, and other documents.
Additionally, the need for controlling who has access to those types of data is also an important consideration. As
such, this feature is at least partially tied to other features like document management and configurable security.
Data mining
Data mining, in the field of computational science, involves "the process of discovering interesting and useful
patterns and relationships in large volumes of data" and includes three computational steps: model-learning, model
evaluation, and model usage. As informatics software allows both research and clinical laboratories to collect and
manage increasing quantities of data, a corresponding demand for tools capable of modeling that data is appearing.
For example, public health laboratories may wish to utilize data mining for statistical analysis and surveillance of
populations for specific diseases. LIMSs like LabWare LIMS and LISs like Orchard Harvest are examples of
laboratory informatics software which incorporate data mining and reporting tools.
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LIS feature
Customizable fields and/or interface

As thorough as some user interface (UI) developers may be in adding relevant fields and interface options for end
users, there are at times options that are either omitted or unanticipated. This has traditionally required the end user
to contact the vendor and ask if the needed option(s) can be added in the next release. However, many modern LIS
vendors have responded instead by adding functionality that gives end users and/or LIS administrators more control
over the user interface.
Aspects of the LIS's user interface that are often customizable by the end user include:
report interface and display
patient profile display
project and experiment display
Note in many cases an interface may be customized through the use of templates and forms, and as such, this
functionality may be closely tied to the configurable templates and forms functionality.
Query capability
As was the case before the advent of databases and electronic data management solutions, today researchers must
search through test results, patient notes, and other types of data to better draw conclusions from experiments,
diagnose patient illnesses, and plan pharmaceutical research activities. Whereas this used to mean browsing through
laboratory notebooks, Excel spreadsheets, or Access databases, now powerful query tools exists within data
management tools like the LIS and ELN. A flexible search algorithm can be implemented to allow users to search a
dataset by patient name (full or partial) or by any accessioning number. Or more advanced query tools may be
implemented to collate and search across multiple datasets.
Query functionality often includes the ability to:
search both transactional data and archived data tables
search multiple databases via an application programming interface (API) or open database connectivity (ODBC)
connection
filter and sort data
collate queried data for further analysis and visualization
create ad-hoc queries
Import data
Data can originate from numerous places in the laboratory. The ability to import that data into a LIS can be
beneficial, especially when an instrument can't be connected or external clients collaborating on a project need to
submit relevant data. Of course instrument interfacing allows for even more importation options. Additional data
validation procedures may be applied to the imported data to guarantee information homogeneity. For the LIS, one
of the common sources of importing data is a separate electronic medical record (EMR) system, for collecting
patient data and test orders.
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LIS feature
62
Internal file or data linking

This feature allows research collaborators
using a LIS to link together sample batches,
reports, protocols, results, and more,
providing greater contextual clarity to
projects and datasets. Examples include:
linking a sample batch to a test or sample
preparation methodology
linking a test process to a particular
experiment
linking a report to a sample batch
linking a group of experiment results to a
raw data file
linking multiple images to a patient
record
linking all experiment results with the
correct reporting test methods
Many informatics systems allow for internal linking of data; however, entities
outside of the system often need to access the data housed within. A LIS is often
capable of such external data linking.
External file or data linking

This feature allows research collaborators using a LIS to link together data and files housed in the database with
data, files, and customers outside the LIS's domain. Examples include:
linking to an external practice management or electronic medical record (EMR) system using an an
HL7-compliant interface
linking one public health data source with others to pool demographic and medical information for better disease
modeling
linking to separate clinical trial laboratory data files within a report
ELN support or integration

The functionality of a LIMS and an ELN began to blur in the 2000s, with both types of software incorporating
features from the other. It has been more common to see a LIMS take on some sort of ELN support (or vice versa),
but less common in the LIS. Though uncommon, some LIS may include some sort of integration or compatibility
with an ELN, and thusly this functionality is at least mentioned.
Export to MS Excel
While Microsoft Excel has long been used within the laboratory setting, a slow shift towards relational databases and
LIMS occurred in the late 1990s and early 2000s. Additional concerns with the difficulties of Excel's validation and
compliance with FDA 21 CFR Part 11 and other regulations have led many labs to turn to data management
solutions that are easier to validate. Nevertheless, laboratories continue to use Excel in some fashion, and thus Excel
integration or data exportation in Excel format is a real need for LIS customers. LISs with this feature allow raw,
processed, or imported data to be exported in the Excel format for further analysis and dissemination elsewhere in
the LIS or externally from it.
LIS feature
Raw data management

While not described as a feature on most LIS vendor websites, a few indicate their product is capable of managing
(import, export, editing, etc.) data in its raw format for future analysis and dissemination.
Data warehouse
An LIS's data warehouse serves the important function of storing, extracting, and managing the data that
laboratories, physician offices, and other facilities produce for the purposes of analysis, reporting, and dissemination,
typically separate from the primary storage database. Data warehouses also offer the benefit of speeding up queries,
making queries and data mining more user-friendly, and smoothing out data gaps.
Project and/or task management

Project and task management within a LIS typically involves the scheduling of tasks to technicians and organizing
associated tasks into a more cohesive unit for better tracking and management. While the functionality of task and
event scheduling can also be found in project and task management, many LISs include functionality beyond
scheduling that warrants the addition of the project and/or task management feature. This functionality includes:
job allocation and rescheduling
instrument workload tracking

pending workload verification
project- and experiment-based workflow management
sample, batch, and document linking
work template sharing
recurring event management
See also: Patient and case management
Test, experiment, and/or trial management

Specimen or sample test management is a common component of a LIS, while experiment and research trial
management functionality is a component of some LISs, often limited to those that are designed to help manage
clinical trials. Test, experiment, and trial management can cover a wide variety of tasks, from setting up the design of
a clinical trial to specimen task assignments, from ordering tests for patients to planning trial experiments. Note: this
may also be referred to as "order management" with some vendors.
It's worth noting this functionality category may seem broad in scope and include other functionality listed on this
page, including workflow management and project and task management. Its inclusion when reviewing software
functionality is primarily to indicate when a vendor or project team indicates the existence of specific test,
experiment, or trial management tools in their software.
Inventory management
Laboratories use a wide array of inventory, from reagents to glassware, from radiopharmaceuticals to laboratory
baths. With that comes the need to know how much/many and the frequency of use. For this, some LIS products
(especially those for pathology labs) now offer limited or full-featured inventory management functionality, which
may include the ability to:
register the origin and demographics of incoming materials.
track used and in-use items via barcodes or RFID tags.
track inventory reduction based on usage and shipping out of the lab.
create alerts for when items reach a certain stock level.
calculate inventory cost and fluctuation.
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LIS feature
64
manage transportation and routing.

manual incrementing/decrementing of items.
track location and usage of laboratory equipment.
track location and usage of reagents.
assign storage locations.
track forensic evidence.
It should be noted electronic equipment may also be considered inventory, and thus there is likely some functionality
crossover with instrument management features.
Document and/or image management

Standard operation procedures, (SOPs),
specifications, reports, graphs, images,
and receipts are all collected and used
in the average laboratory. With a LIS
already designed to reference and store
test and patient data of all types, it
makes sense to include functionality to
create, import, export, and manage
other sorts of data files. As
experimental data can be indexed,
queried, and linked, so too can
document data. Functionality of a
typical document management system
includes the ability to:
upload and index documents.
add images and photos inline to a
patient or case entry.
enforce version control.
Standard operating procedures, workflow diagrams, and business models can all be
handled effectively with document management functionality.
provide full text searches.

export to PDF, XML, or other relevant formats.
add documents as attachments.
Patient and case management

The laboratory information system (LIS) has played an important role in the case management tasks of
patient-centric and clinical laboratories. LIS products have included patient or case management tools suitable for
the clinical, public health, and veterinary industries, as well as the fields of law enforcement and forensic science.
Functionality seen in the patient and case management feature includes:
case accessioning and assignment

disease tracking
trend analysis
clinical history follow-up
out-of-range result alerts
document and result association
evidence control
study management
collating of patient data across multiple spectrum
LIS feature
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Workflow management
Workflow management is common in the laboratory, acting as a
graphical representation of planned sequential steps to either automate
or clarify a process or experiment within the lab. Separate
standards-based workflow management systems (in the form of a
software component) have traditionally performed this task. However,
in the 2000s vendors began incorporating workflow management
functionality into their laboratory informatics software, reducing
customization headaches in the process.
Capturing workflow in the lab is becoming more
commonplace for laboratory informatics
products.
Modern commercial and open-source LIS solutions recognize clinical

laboratory workflow often has its own share of requirements, requiring
specific workflow management functionality, including:
managing the request cycle within a laboratory
organizing and executing diagnostic testing

managing specific chemistry- and biology-related procedures
defining activity attributes
managing automation tools to better workflows
re-route samples based on changes to a process
dynamically modifying workflow in case of future changes
receiving notification of changes to the workflow
Specification management
Specification (spec) management is vital to not only the manufacturing and research industries but also to a host of
other laboratories requiring precise measurements and infallible test methods. Just as the ASTM offers standards and
specs for laboratory informatics software, so too do users have standards and specs for their laboratory.
Spec management has primarily been seen in a manufacturing execution system (MES) or a LIMS, but occasionally
a LIS may appear which includes such functionality. With spec management in place, laboratories can then:
enforce standard operating procedures and business rules.

create specs down to a project or sample level.
validate recipes and procedures.
accept or reject sample batches.
document internal and external spec history.
Note some of the functionality of spec management may cross over into the realm of quality control and data
validation.
Customer, supplier, and physician management

Unless a laboratory is conducting internalized independent research, in most cases it will do business with external
entities such as contract labs, physician offices, equipment providers, and reagent suppliers. In some cases, even
internal employees may be considered a customer, necessitating documentation of who is using the system and in
what ways. For a veterinary lab, the customer may be the animal and handler. For a forensic lab the customer may be
more complex: internal staff, university staff, police departments, and maintainers of nationwide crime databases
may all at some point act as customers. In these cases, documenting these various points of contact and linking them
to tests, equipment, and patients becomes vital. Managing demographics, complaints, correspondence, and history
are all feasible with customer, supplier, and physician management functionality. This process is often made simpler
LIS feature
through the use of a more context-neutral entity creation system, which allows for more flexible management of
contacts.
This feature may also be referred to as contact management, an address book module, or a customer service module.
Billing and revenue management

While the finances of a laboratory are important, they've typically been handled separately as a business process.
However, some LISs include additional functionality to make handling financial transactions and documentation of
all sorts possible within the LIS. In theory, such functionality brings the possibility of keeping more of a laboratory's
data centrally located and queryable. This feature may include:
payment processing
expense reporting
price quotes
revenue management
workload tracking of billable hours
bill of materials
sales team and client management
profitability analysis
medical necessity checks

Regulatory compliance
The topic of whether or not a LIS meets regulatory compliance is often a complex one. While Title 21 CFR Part 11
has arguably had the largest influence on an electronic data management system's compliance, other influential
standards have shaped the way laboratory informatics systems handle and store data. Other compliance-based codes,
standards, and regulations include:
ASTM
ASCLD/LAB
Classified data
Freedom of information legislation (various)
GALP and GAMP
HIPAA
Health Level 7
ICD
ISO/IEC 17025
ISO 9000/9001
ISO/TS 16949
ODBC
TNI and NELAP
Title 40 CFR Part 3
With so many codes, standards, and regulations, LIS consumers are advised to contact vendors with their user
requirements and ask how the vendor's software meets and/or exceeds those requirements.
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LIS feature
67
QA/QC functions
The quality management functions of a LIS allow users to maintain a level of necessary quality across many of the
functions in a laboratory. Some of the activities quality assurance / quality control functionality allows for includes:
force random review of cases by second pathologist before case verification

receive and process QC results from laboratory analyzers
create user rules
set up custom alerts and flags for out-of-range results
observe standard deviations in outcome research
review and sign off on data electronically
delta checking
Performance evaluation
As document and file management plays an important role in clinical and research laboratories, it only makes sense
to collate and store all the associated data for future reference, including documentation relating to individual
training and performance. Changes to laboratory techniques, scientific understanding, and business practices force
lab technicians and researchers to learn, reevaluate, and demonstrate competency in order to maintain quality levels
in the laboratory. Evaluations can frequently extend beyond staff members, however. Clinics, visit types, vendors, or
test species can also be tracked and evaluated based on custom criteria. The performance evaluation functionality of
a LIS makes this possible.
That functionality typically includes the ability to maintain training records and history, and also to link that training
to a technique or piece of equipment. Afterwards, the staff member, vendor, etc. can be marked as competent or
certified in the equipment, knowledge, or process. Periodical assessment of the training and its practical
effectiveness can later be performed. Productivity of an entity or process can also be gauged over a certain date range
based on tracked time, pre-determined milestones, or some other criteria.
Audit trail
As codes and regulations like Title 21 CFR Part
11 mandate "computer systems (including
hardware and software), controls, and attendant
documentation" utilize electronic signatures and
audit trails, LIS developers must put serious
thought into how their software handles audit
trail functionality. The audit trail
documentation of the sequence of activities that
have affected an action must be thorough and
seamlessly integrated into the software.
Information recorded in the audit trail typically
includes:
Whether validating an instrument's data or an entire LIS, maintaining an audit
trail is an important part of 21 CFR Part 11 compliance.
case number
accessioning number
transaction type
amount and quantity prior to change
operator code
time stamp
location
LIS feature
user notes
Chain of custody
The chain of custody (COC) of an item is of varying importance, depending on the type of laboratory. A highly
regulated laboratory that works under Code of Federal Regulation or other guidelines makes tracking COC a vital
part of its operations. This is especially true in forensic labs, which depend on continuous accountability of their
evidence collection, retention, and disposal procedures. As with an audit trail, a laboratory depends on recorded
information like user ID, time stamp, and location ID to maintain a robust and accurate COC. Barcodes and RFID
tags, inventory management, and configurable security roles all play an important part in maintaining chain of
custody.
Configurable roles and security

Many roles exist within the clinical and research setting, each with its own set of responsibilities. And just as the role
an individual plays within the laboratory may change, so may the responsibilities associated with each role. This sort
of change necessitates a flexible and configurable security system, one that allows for the placement of individual
LIS users into standardized security roles which provide role-specific access to certain functionality. Additionally, as
responsibilities change within roles, that same flexible configuration is necessary for assigning or restricting access
to specific functionality for each existing or newly created role.
Of course, roles aren't always assigned on an individual level. Often large groups of individuals may need to be
assigned to roles, necessitating group assignments for security purposes. For example, a group of hospital laboratory
trainees may not be given access to the inventory management functionality of the system through a custom
"Trainees" group role, while the head of the lab may be given the "Administrator" role, which allows that individual
to access a much broader spectrum of the LIS's functionality.
Data normalization
For the purposes of describing LIS functionality, "data normalization" specifically refers to the process of ensuring
incoming/imported data into the LIS is standardized to the same format of existing data.
Here's an example to better explain this issue. When a LIS is initially configured, in most if not all cases a clear
standard can be set for how logged test results and their associated measurements pre- and post-analysis are recorded
in the system. Perhaps all temperatures will be recorded in Celsius to three decimal places. If temperature data
imported from a spreadsheet or a lab instrument is not in this format, the LIS can normalize the incoming data to
match the standard already set for existing temperature data. This ensures consistency within the database and
typically leads to better data validation efforts later on.
Note: Some LIS developers may include data normalization functionality within what they may refer to as data
validation functionality. The line between these two may be blurred or not exist at all.
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LIS feature
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Data validation
For the purposes of describing LIS
functionality, "data validation" specifically
refers to the process of ensuring existing
data in the LIS either pre-analysis or
post-analysis sufficiently meets any
number of standards or thresholds set for
any given data management process. This
validation process may be completely
automatic and system-based, or it may also
include additional steps on the part of the
user base utilizing additional LIS
functionality, including verification of
standard operating procedures (SOPs), QC
samples, and QA approval.
Note: This functionality shouldn't be
confused with the process of validating the
application itself, which is an entirely
different process partially falling under
regulatory compliance and involves the
process of ensuring "the software is
performing in a manner for which it was
designed."
In a LIS, data and data models can be forced through a validation process to
remove errors and reconcile that those data and models.
Data encryption
The existence of this functionality in a LIS indicates the software has the ability to protect the integrity and
authenticity of its housed data through the use of a variety of technologies which makes data unreadable except to
those possessing a key/right/etc. to unlock/read the data. This functionality is especially vital to the web-enabled LIS,
which transfers information over the Internet in a client-server relationship. As a wide variety of encryption
technologies exist, it's generally a good idea to consult with the developers of a LIS to determine the strengths and
weaknesses of their employed encryption methods.
Version control
Version control is a form of safeguard which helps preserve data integrity and thus ties in with the topic of
regulatory compliance. This is typically done by creating a modifiable new version of a piece of information rather
than allowing the original to be modified. Such versioning may be applied to a wide variety of digital information
housed in the LIS, including templates, training certifications, instrument logs, specifications, and process and
procedure (P&P) documentation. Information tracked with such revisions includes attributes like user name, time the
edit was made, and what exactly was edited. This also benefits those managing audit trails and chains of custody.
Other LIS vendors may employ a different form of version control called file locking, which simply puts the affected
information into a read-only mode for users while someone else is busy editing it. Another popular strategy is to,
rather than locking the file, allow multiple people to edit a piece of information, later merging the various edits.
Potential LIS buyers may need to inquire with developers to determine what type of versioning scheme is used in the
vendor's software.
LIS feature
Automatic data backup

The existence of this piece of functionality in a LIS usually means information contained in one or more associated
databases or data warehouses can be automatically preserved in an additional backup file. The save location for that
file as well as the scheduled backup time is configurable, typically through the administrative module of the
software.
Environmental monitoring
While not common at all, a few LIS may allow users to monitor the environmental conditions of not only sample
storage containers but also the entire laboratory itself. Attributes like humidity, air quality, and temperature may be
monitored to ensure sample storage units and experiments maintain desired conditions. This monitoring may be done
by treating the storage container as a device, which must be interfaced with the LIS. Alarms may be able to be
configured to notify staff if a storage container's environmental attributes go beyond a certain threshold.

Custom reporting
Reporting often provides useful information representation for gaining a clearer picture of collected data and
potential trends. At a minimum, a number of pre-configured report templates typically come standard with a LIS.
However, other systems are more flexible than others, offering the ability to customize reports in numerous ways.
The most popular attributes of custom reporting include custom headers, custom information placement, charts, pivot
tables, and multiple output formats.
Note: Some LIS vendors may offer custom reporting as an option as an added cost, depending on the level of
customization required.
Synoptic reporting
Synoptic reporting is a specific type of reporting applicable to pathology and other associated laboratories. Synoptic
reporting essentially involves a structured, pre-formatted "checklist" of clinically and morphologically relevant data
elements (ideally passed to a relational database where they are efficiently organized, searched, and retrieved), with
the intent of making reporting more efficient, uniform, and relevant to internal and external researchers. This style of
reporting has the advantage of obviating the need for transcription services, reducing specimen turnaround time, and
prioritizing the presentation of large amounts of diagnostic information. Some LISs, especially those oriented
towards pathology, may include this specialized functionality. In some cases, a configurable templates or form may
be utilized to structure a report in a synoptic format, providing similar functionality to a separate synoptic reporting
module.
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LIS feature
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Report printing
Today's software almost universally offers the ability to print reports and other materials, so this feature may seem a
bit redundant to list. Nonetheless, printer support is a feature worth confirming when considering a piece of
laboratory informatics software.
Label support
The label typically affixed to a sample container or piece of equipment is a vital part of many laboratory
operations. Identifying information such as sample number, batch number, and barcodes are printed on such labels to
ensure optimize managing the location of items in a lab. As such, numerous LISs allow users to design and print
labels directly from the software.
Barcode and/or RFID support

Barcodes offer many advantages to laboratory techs handling samples,
including more accurate data input, tighter sample/instrument
associations, tighter sample/study associations, and more room for
human-readable information on a label. Given such advantages, many
laboratory informatics developers have integrated barcode support into
their software, including support for symbologies like Code 128, Code
39, and Interleaved 2 of 5. Aside from printing options, a LISmay also
offer support for a variety of barcode readers.
The word "Wikipedia" encoded in Code 128 and
Code 39
Additionally, some LIS include the ability to handle radio-frequency

identification (RFID) tags, which have several advantages over a more
traditional label-based approach to accessioning.
Barcode support and label support are typically found together in LIS software, but not always, thus their separation
into two features.
Export to PDF
A LIS with this feature is able to collect and save information into a Portable Document Format (PDF).
Export to MS Word
A LIS with this feature is able to collect and save information into a Microsoft Office Word format.
Export to HTML or XML

A LIS with this feature is able to collect and save information into a HyperText Markup Language (HTML) and/or
Extensible Markup Language (XML) format.
Fax integration
A LIS with this feature is able to connect with a fax machine and send information to it via manual input,
automatically, and/or at scheduled intervals.
LIS feature
72
Email integration
A LIS with this feature is able to integrate with and use the electronic mail information exchange method to send
reports, alerts, and more manually, automatically, and/or at scheduled intervals.
Base functionality
Administrator management
The administrator management tools of a LIS allows researchers to set up the software most optimally for the facility
and its projects. Through the administrator management interface, other features may be accessed like setting up user
roles and scheduling automatic data backups.
Like report printing, administrator management is nearly ubiquitous in laboratory informatics software, generally
considered a mandatory feature. However, for the purposes of being thorough, it's important to point out its
existence.
Modular
This feature indicates that a LIS has an intentional modular design, which separates some functionality into
manageable components of the overall system. Generally speaking, a modular design allows for 1. the structured
addition of new functionality to a LIS and 2. the limiting of overall effects on the system design as new functionality
is added.
Instrument interfacing and management

In laboratories there are instruments, and with those instruments comes scientific measurements which produce data.
It's therefor natural a researcher would want to connect those instruments to a laboratory information system, which
is already organizing and storing laboratory data for hospitals and medical research facilities. This sort of interfacing
is typically handled with instrument-to-software interfaces, which started out as merely data-transfer mechanisms.
Later that interface mechanism became much more robust as a data management tool, though often at great expense
with heavy involvement from third parties. Today, "vendors can act as single source providers of the entire
instrument interfacing solution,", providing a cheaper and smoother solution to laboratory informatics customers. In
the clinical laboratory setting, a LIS vendor may have additional considerations to make, such as Health Level 7
(HL7) triggers, messages, and segments transported across communication interfaces.
Mobile device integration
In some cases mobile devices like these may

access and utilize a LIS, typically through a Web
portal or special mobile version of the software.
While not ubiquitous by any means, LIS developers are increasingly

including support for mobile devices in their software, usually in the
form of a separate mobile version of the software. Research and
development labs, for example, potentially can put mobile technology
to use in the laboratory as remotely monitoring a lab or using mobile
phone microscopy. Those uses aside, the relatively simple action of
recording and reviewing laboratory research results while on the move
or at a conference gives researchers flexibility, and LIS developers like
McKesson are beginning to include that functionality.
LIS feature
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Third-party software integration

A few LIS vendors either incorporate third-party software into their product or they provide the means to integrate
the LIS with other applications. The most typical integration involves simply communicating with common
authoring tools like Microsoft Word, allowing users to work directly from the third-party application and then
transferring the information to the LIS.
Alarms and/or alerts

Alarms and alerts in a LIS can be automatic or scheduled, and they can come in the form of an e-mail, a pop-up
message, or a mobile text message. For example, when a test result goes out-of-range, an automatic warning message
can appear on the screen of the lab analyst responsible for the test. Another example: a scheduled alert can be
e-mailed to a lab technician every month indicating a piece of laboratory equipment needs routine maintenance. Both
scenarios represent a tiny fraction of the possible implementation of alarms and alerts in a LIS, highlighting how
powerful (yet easy to take for granted) this feature is.
Work-related time tracking

This feature specifically refers to a LIS' ability to track the amount of time an employee spends at work in general
(for payroll purposes) or on more specific projects and tasks (as part of an employee work evaluation program). May
also be referred to as "workload tracking" or "workload tracking."
Voice recognition system

A LIS with this feature allows some functions of the software (for example, accessing test results) to be accessed via
voice commands.
External monitoring
This feature allows clients and/or collaborators outside the laboratory to monitor the status of experiments, test
results, and more via an online web portal or, less commonly, as activity alerts sent via e-mail or SMS.
Messaging
The messaging feature of a LIS may refer to one of two (or both)
things:
a built-in instant messaging system that allows users to converse
with each other through text messages real-time
an SMS text messaging integration that allows the users or the LIS
itself to send messages or alerts to one or more user's mobile or
smart phone
Commenting
An instant messaging client built into a LIS often

makes it easier to collaborate.
Clinical data collection and research collaboration require data sharing

and communication tools to be most effective. One of the collaborative
communication features of some LISs is commenting on test results,
patient records, or study protocols.
LIS feature
Multilingual
If a LIS is listed as multilingual, its an indication the software interface can be configured to display more than one
language depending on the preference a user or administrator chooses. Some LIS interfaces can only be displayed in
one of two languages (English or German, for example), while others come configured with support for dozens of
languages.
Network-capable
This feature is perhaps archaic and/or obvious, but it is mentioned nonetheless. It's generally applied to a
non-web-based LIS installed over a local or wide-area computer network, essentially indicating the LIS is not an
isolated application, but rather one that can interface with other instances or other networked instruments.
Web client or portal

A LIS with a web client or portal is either a web-based LIS (one that is not installed on every computer, but rather is
hosted on a server and accessed via a web browser) or a non-web-based LIS with an included portal to access it via
the Internet.
Online or integrated help

This indicates a LIS has help infrastructure integrated into the software, support documentation via the vendor's
website, or both.
Software as a service delivery model

This indicates the software can be licensed and utilized via the software as a service (SaaS) delivery model.
Usage-based cost
While rare, some software vendors allow potential clients to license and utilize the vendor's software under a
usage-based cost model. An example of this model in use is Bytewize AB's O3 LimsXpress, which has a cost
directly related to the amount of samples processed each month.
References
74

The intention of this document is 1. to assist labs searching for a laboratory informatics product with identifying their
system needs and 2. to help labs better determine if a specific vendor/product meets their requirements in the form of
a request for information (RFI). The idea is to allow users to incorporate a standardized specifications sheet in their
comparison of various LIMS and other laboratory informatics products.
This questionnaire lists the extensive requirements of a LIMS as well as other laboratory informatics systems. (See
below for more about this.) The questionnaire is organized such that sections 1.0 through 1.4 offer questions
applicable to most any laboratory informatics system, be it a LIMS or an ELN. Section 1.5 covers functionality
found specifically in software systems other than LIMS.
This questionnaire is comprehensive and includes many items that do not apply to every lab. Additionally, some
laboratories' requirements include a functionality item not common to other labs. Section 1.6 "Industry-specific"
contains a selection of those industry-specific requirements and will continue to be amended over time. The last
section, 1.7 "Custom functions," is designed for the vendor to insert any additional functionality that doesn't fall
under the categories provided.
When referencing a particular item for someone else, use the section number followed by the requirement letter, e.g.
1.4.2.f for "Does your system allow the administrator to create custom screens, applications, and reports? Please give
details."
More about this questionnaire

As noted above, this questionnaire was originally designed to cover aspects of a laboratory information management
system (LIMS). However, a significant portion of this page if not most of it could easily apply to other laboratory
informatics systems like ELNs. As such, we took the approach of adding addenda (as seen in section 1.5 and 1.6)
that provide additional requirements unique to other systems and industries. If you're evaluating several
industry-neutral LIMS, you likely don't need 1.5 and 1.6.
Requirement code and notes

In responding to each requirement, the vendor must select a requirement code from the following:
Y: Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
YC: Meets requirement only with customization (additional code, using a third-party application, etc.)
N: Does not meet requirement
I: Informational response only, N/A
The vendor should ideally enter a requirement code and a response for each functionality question.
Printing or saving
The print/export options in the navigation on the far left give you a few options for saving this and other pages,
printing them for later.
Notice you'll have to open 1.5 and 1.6 in separate pages to view, print, and save them.
Note: Tables are currently not being rendered in PDFs as we like through the MediaWiki Collection extension [1].
While we sure would love for you to make a PDF of this document, be warned: the tables don't format as intended,
using either the "Create a book" or "Download as PDF" processes. For now you're best off selecting "Printable
version" and printing that instead.
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1.0 Vendor information

1.0 Vendor information
Company name
Physical address
Website
LIMSwiki web page
Contact name and title
Contact e-mail
Contact phone and fax
Years in business
1.1 Vendor services

1.1 Vendor services
Request for information
a. Does the vendor offer an online demonstration and/or an on-site demonstration?

b. Does the vendor provide a detailed project approach and plan that includes the project team, timeline,
deliverables, and risk and issue management procedures?
c. Does the vendor explain their overall project approach, acknowledgement of the deliverables, time/schedule
constraints, and any other criteria for the project?
d. Does the vendor provide reliable cost estimates and pricing schedules, including all products and services in
the scope of work?
e. Can the vendor detail the amount of time and staff that purchaser will have to provide for the implementation
process?
f. Can the vendor explain the maintenance and support offered during and after implementation, including times
and methods of availability, issue escalation and management, etc.? Give details.
g. Does the vendor provide a support schedule for the implementation process, including optional support levels
and their function and availability? Give details.
h. Does the vendor provide support during the "go-live" period between system validation/operational
deployment and final acceptance/beginning of maintenance and support agreements?
i. Does the vendor provide a gap analysis after initial system installation, identifying the deliverables or tasks
remaining?
j. Does the vendor provide a table linking each deliverable to the corresponding user requirement specification it
fulfills?
k. Does the vendor use a consistent training methodology for training new users? Give details.
l. Does the vendor supply LIMS-specific training program curricula?
m. Does the vendor provide user, administrator, developer, installation, and reference manuals? Give details.
n. Does the vendor provide design qualification documentation?
o. Does the vendor provide installation qualification documentation?
p. Does the vendor provide operation qualification documentation?
q. Does the vendor provide performance qualification documentation during implementation?
Requirement
code
Vendor
response
77
r. Does the vendor provide well-documented system upgrades that authorized users can independently install?
s. Does the vendor provide source code for the system?
t. Does the vendor provide an optional comprehensive set of test codes suitable for use by the purchasing facility?
1.2 Information technology

1.2.1 General IT
1.2.1 General IT
a. Does your system operate with a web-based interface (hosted on a server and accessed via a web browser) or
on a more traditional client-server architecture? If web-based, what technology does it support?
b. Does your system contain a single database that supports multiple laboratory sites and departments?
c. Does your system's database conform to the Open Database Connectivity Standard (ODBC)?
d. Did you design your system so upgrades to the back-end database do not require extensive reconfiguration or
effectively cripple the system? Please describe.
e. Did you design your system to not be impacted by multiple users or failover processes? Please describe.
f. Does your system apply security features to all system files?
g. Does your system apply login security to all servers and workstations accessing it?
h. Does your system provide a workstation and server authentication mechanism?
i. Does your system apply Secured Socket Layer (SSL) encryption on the web client interface?
j. Does your system encrypt client passwords in a database with support for multi-case and special characters?
k. Does your system provide all secured users access to its data via the Internet, LAN, or direct modem
connection?
l. Does your system use TCP/IP as its network transport?
m. Does your system contain an archive utility that doesn't require off-line mode?
n. Does your system provide local backup and restore capability without support intervention?
o. Does your system maintain the transactional history of system administrators?
p. Does your system maintain an analyst communication log, accessible by the administrator?
q. Does your system architecture facilitate the incorporation of new technology and interfaces?
Requirement
code
Vendor
response
78
1.2.2 Hardware environment

1.2.2 Hardware environment
Requirement code Vendor response
a. Does your system prove compatible with a variety of hardware environments? Please describe how.
b. Can your system be utilized with a touch-screen?
1.2.3 Software environment

1.2.3 Software environment
Request for
information
Requirement Vendor
code
response
a. Does your
system utilize
a
non-proprietary
database such
as Oracle or
Microsoft
SQL Server?
Please
explain.
b. Does your
system prove
compatible
with a variety
of software
environments?
Please
describe how.
1.3 Regulatory compliance and security

1.3.1 Regulatory compliance
1.3.1 Regulatory compliance
a. Does your system support 21 CFR Part 11 and 40 CFR Part 3 requirements, including login security, settable
automatic logouts, periodic requirements for mandatory password changes, limits on reusability of passwords, and
full electronic signature? Please explain in detail.
b. Does your system support ISO/IEC 17025 requirements? Please explain how.
c. Does your system support HIPAA requirements? Please explain how.
d. Does your system support GALP and/or GAMP standards? Please explain how.
e. Does your system support the standards The NELAC Institute? Please explain how.
f. Does your system meet government requirements for handling classified information and documents?
Requirement
code
Vendor
response
79
g. Does your system maintain audit and specification violation trails of all data manipulation such as result and
header information changes as consistent with all applicable regulations and standards? Provide details.
h. Does your system's audit log retain all data, prohibit any deletions, allows user comments, and allow reporting of
contained information?
i. Does your system provide additional persistent auditing capabilities, such as the audit of cancelled tests and
scheduled system functions? If so, what?
j. Does your system provide user-selectable NELAP-compliant internal chain of custody that tracks all samples and
associated containers from the time they are collected until disposed of? Please explain how.
k. Does your system provide the ability to insert/manage secure electronic and/or digital signatures?
l. Does your system incorporate automatic date and time stamping of additions, changes, etc.?
1.3.2 Security
1.3.2 Security
a. Does your system allow system administrators and managers to configure multiple levels of user rights and
security by site location, department, role, and/or specific function? Please explain the depth of this security.
b. Does your system allow administrators to reset user passwords?
c. Does your system enforce rules concerning password complexity, reuse, and expiration? If so, how?
d. Does your system provide automatic logout based on keyboard or mouse inactivity?
e. Does your system prompt users for a reason for database record changes?
f. Does your system allow administrators to modify records, while also maintaining an audit trail of such actions?
g. Does your system allow authorized personnel to review audit logs at will?
h. Does your system allow authorized users to query and print chain of custody for items, cases, projects, and
batches?
i. Does your system allow supervisors to override chain of custody?
j. Does your system automatically track when supervisors review critical result values?
k. Does your system provide email notification of lockout, security access, and improper workstation access?
l. Does your system allow multiple users to connect simultaneously to a contract lab?
m. Does your system provide read-only access to contract laboratory results?
n. Does your system prohibit issuing reports outside of qualified areas while also allowing reports to be viewed
locally or remotely based on security application limits and/or sample ownership? If so, how?
1.4 General system functions

1.4.1 General functions
Requirement
code
Vendor
response
80
1.4.1 General functions

a. Does your system offer non-LIMS trained personnel the ability to easily access system data via an intuitive,
user-friendly Windows-type graphical user interface (GUI) which permits the display of data from sample points,
projects, and user-defined queries, and can be configured to language, character set, and time zone needs?
b. Does your system permit remote access for users, system admins, and support agents?
c. Does your system allow for the use of navigation keys to freely move from field to field?
d. Does your system allow data tables to be sorted?
e. Can your system send on-screen output to a printer or file? If so, does it contradict view-only statuses?
f. Does your system provide single data entry, automatically populate other data fields, and remember pertinent and
relevant data so it doesn't need to be re-entered, selected, or searched for?
g. Does your system support multiple users entering data simultaneously?
h. Does your system eliminate (or significantly reduce) redundant data entry and paper trails? If so, how?
i. Does your system contain one or more spell-check dictionaries that allow authorized users to add, edit, or remove
entries?
j. Does your system provide full database keyword and field search capability, including the use of multiple search
criteria?
k. Does your system include the ability to search multiple databases, including those containing legacy data?
l. Does your system interface with or import existing data from other systems and/or databases?
m. Does you system cleanly convert migrated data to allow for reporting of historical sample collections? If so,
how?
n. Does your system provide data archival and retention functionality for both paper-based and electronic laboratory
records? If so, what is your system strategy for maintaining the archives as technology changes?
o. Does your system allow users to associate and store both sample- and non-sample-related objects such as pictures
from microscopes, GCMS scans of peaks, PDF files, spreadsheets, or even raw data files from instrument runs for
later processing?
p. Does your system store more non-traditional information and objects like project- or sample-specific special
information fields, user-defined fields, scanned chain of custodies and digital photos of such items as sample events,
bitmaps, movies, and .wav audio files?
q. Does your system issue sequential numbers for chain of custody?
r. Does your system's numbering scheme allow for sub-numbering while maintaining parent-child relationships?
s. Does your system efficiently utilize standardized data input points and enhanced individual workload tracking?
t. Does your system capture data from all laboratory processes, ensuring uniformity of statistical reporting and other
electronic data shared with designated users of the data?
u. Does your system link or embed standard operation procedures (SOPs) to/in other objects like analysis requests
and test results?
v. Does your system notify users of events like the scheduling, receipt, and completion of tasks?
w. Does your system include the ability to set up alerts via email?
x. Does your system have real-time messaging capabilities, including instant messaging to one or more users?
y. Does your system support the use of a voice recognition system (for navigation or transcription) or have that
functionality?
z. Does your system offer integrated or online user help screens?
Requirement
code
Vendor
response
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1.4.2 Configuration and customization

1.4.2 Configuration and customization
Requirement
code
Vendor
response
Requirement
code
Vendor
response
a. Can your system can be configured to meet the workflow of a laboratory without additional programming?
Please explain how.
b. Can your system easily and efficiently be modified to meet lab growth and changing business needs? Please
explain how.
c. Does your system include an application programming interface (API)? If so, what kind? If web, does it use
Simple Object Access Protocol (SOAP) or representational state transfer (REST)?
d. Can your system expand to accommodate a new discipline? If so, how?
e. Can your system support customized screens with user-definable information specific to a customer,
department, analysis, etc.?
f. Does your system allow the administrator to create custom screens, applications, and reports? Please give
details.
g. Does the system allow a user to independently add fields without requiring reconfiguration of the system, even
after routine upgrades and maintenance?
h. Does your system allow a user to independently add universal fields on all samples logged into the system at
any time during or after implementation, while neither voiding the warranty nor requiring vendor review at a later
date?
i. Does your system support the definition and maintenance of edit tables and lists?
j. Does your system dynamically change captions (labels) on system fields?
k. Does your system have dynamically configurable limit periods and notification hierarchy?
l. Does your system allow for the integration of additional printers and scanners both locally and externally?
1.4.3 Receiving and scheduling

1.4.3 Receiving and scheduling
a. Does your system track status and workflow of the accession throughout the laboratory lifecycle, from
submission to final analysis, including receiving, diagnostic testing, diagnostic test result reporting, and billing?
b. Does your system support barcoded specimen labeling and tracking?
c. Does your system create and maintain a unique electronic accession record for each accession received?
d. Does your system support standard-format digital picture and document upload and attachment to electronic
accession records?
e. Does your system support a user-configurable, spreadsheet-style, templated multi-sample (batch) login without
requiring additional programming?
f. Does your system support the modification of sample or sample batch information prior to actual multi-sample
(batch) login?
g. Does your system support ad-hoc samples not predefined in the sample point list during multi-sample (batch)
login?
h. Does your system create, save, and recall pre-login groups for routine samples to simplify recurring logins?
i. Does your system streamline the login of recurring sampling projects?
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j. Does your system automatically generate labels for recurring samples and sample groups?
k. Does your system allow authorized users to generate user-definable or rules-based chain of custodies,
worksheets, routing sheets, and custom labels upon sample login?
l. Does your system provide a comprehensive view of all samples and projects in the system using a color-coded
status view of the current and scheduled samples via user-configurable templates, all without requiring additional
programming?
m. Does your system include environmental monitoring (EM) functionality or integrate with an external EM
product?
n. Does your system prevent a sample from being placed in a report queue until approved?
o. Does your system include comprehensive sample scheduling, tracking, and sample flow management?
p. Does your system allow authorized users to accept, cancel, re-run, and override attributes of one or multiple
tests for a given patient?
q. Does your system allow authorized users to review the available test types in the system, including their
reference range and units of measure?
r. Does your system have a "miscellaneous" test code to allow a test undefined in the system to be ordered and
billed?
s. Does your system allow authorized users to schedule routine samples on an hourly, daily, weekly, or monthly
basis, allowing them to be enabled and disabled as a group?
t. Does your system generate an hourly, daily, weekly, or monthly sampling schedule from a schedule database?
u. Does your system schedule and assign tasks based on available inventory and personnel?
v. Does your system support automatic assignment and scheduling of analysis requests?
w. Can your system receive accession/analysis request information from web-enabled forms?
x. Can your system electronically receive and process collection and analysis request information and schedules
from third parties?
y. Does your system have an inter-lab transfer function?
z. Can your system process automated uploading of field-derived sample collection data?
aa. Does your system allows users to handle billable and non-billable tests on the same accession?
ab. Does your system support tracking of shipping and receiving?
1.4.4 Analysis and data entry

1.4.4 Analysis and data entry
a. Does your system support a variety of test protocols, each capable of storing test comments, test required, and
special information like GCMS conditions or special objects associated with the test? Please give details.
b. Does your system provide normal data range values for diagnostic tests?
c. Does your system includes default input values for diagnostic tests?
d. Does your system provide for a single test code requiring multiple analytes as targets?
e. Does your system limit test code authorization to only qualified personnel and maintain their certification(s) to
run assigned tests?
f. Does your system support and qualify text-based tests?
g. Does your system support single-component tests such as pH, BOD, CD, etc.?
Requirement
code
Vendor
response
83
h. Does your system allow users to specify a single-component, multi-component, or narrative text test or group of
tests, which represent all tests required?
i. Does your system permit user-generated and modifiable calculations (based on a formulaic language) to be
applied to all tests?
j. Does your system distinguish between routine and duplicate analysis?
k. Does your system provide an overview of all outstanding tests/analyses for better coordination of work
schedules?
l. Does your system notify analysts of applicable safety hazards associated with a sample, reagent, or test before
testing begins?
m. Does your system electronically transfer an item during testing from one functional area to another?
n. Does your system's user interface display visual indicators such as status icons to indicate a sample's status in
the workflow?
o. Does your system allow file transfer of data from instruments via intelligent interfaces or
multi-sample/multi-test ASCII files, with full on-screen review prior to database commitment?
p. Does your system permit manual data entry into an electronic worksheet of test measurements and results?
q. Does your system allow incorrectly inputted data to be manually corrected?
r. Does your system provide colored visual indication of previously entered data as well as new data associated
with a single sample when a result is entered, with the indicator changing color if the value is out of specification?
s. Does your system allow automated or semi-automated data insertion?
t. Does your system store non-narrative textual results in searchable fields?
1.4.5 Post-analysis and validation

1.4.5 Post-analysis and validation
a. Does your system update sample/item status when tests are completed?
b. Can your system automatically reorder a test or order additional tests if results don't meet lab-defined criteria?
c. Does your system read results from previously entered tests to calculate a final result and immediately display
the calculated result?
d. Does your system allow authorized users to review all analytical results, including pricing, spec violations,
history or trend analysis by analyte, and comments?
e. Can your system graphically display the results of one or more tests in a graph (normalized or otherwise) for the
purpose of visualizing data or searching for possible trends?
f. Does your system allow on-screen review of the stored test result, diluted result with corrected method detection
limits (MDLs), and qualifiers after running samples for multiple dilutions as in gas chromatographymass
spectrometry (GC-MS)?
g. Does your system display the standard operating procedure (SOP) associated with each test result to ensure
proper techniques were used?
h. Does your system store test-related analysis comments with the test?
i. Does your system provide auto-commenting for common laboratory result comments?
j. Does your system provide for high-volume multi-component transfers of test results, with the ability to
automatically match samples to data files in either a backlog mode or a designated file mode, to parse the data, and
to review and commit the sample data?
Requirement
code
Vendor
response
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k. Does your system's results validation process access all information about a sample or group of samples,
including comments or special information about the sample?
l. Does your system's results validation process check each result against its individual sample location
specifications (both warning and specification limits)?
m. Does your system support validation at the analysis and sample level, while also prohibiting sample validation
when analysis validation is incomplete?
n. Does your system use a menu-driven process for results validation?
o. Does your system provide secure electronic peer review of results?
p. Can your system clearly differentiate released preliminary data from fully validated results?
q. Does your system validate/approve data prior to being moved to the main database?
r. Does your system fully manage all aspects of laboratory quality control, including the reporting and charting of
all quality control data captured in the lab? Please explain how.
s. Does your system provide a base for a quality assurance program, including proficiency testing, scheduled
maintenance of equipment, etc.? Please explain how.
t. Does your system distinguish QA/QC duplicates from normal samples?
u. Does your system allow QA/QC tests to be easily created and associated with the primary analytical test?
v. Does your system allow manual entry of QA and QC data not captured as part of the system's regular processes?
w. Does your system calculate monthly QA/QC percentages for testing?
x. Does your system automatically flag out-of-range quality control limits?
y. Does your system check data files for specification and corrects them for specific reporting and analyte limits
and qualifiers like dilution factor, automatically assigning qualifiers based on project analyte limiting?
1.4.6 Instruments
1.4.6 Instruments
a. Does your system bilaterally interface with instruments and related software? If so, please provide details.
b. Can your system download data directly from laboratory instruments?
c. Does your system permit the defining and exporting of sequences to instruments?
d. Does your system track and report on laboratory equipment usage?
e. Does your system allow automatic or manual reservation/scheduling of laboratory instruments?
f. Does your system automatically (or manually allow an authorized user to) remove an instrument from potential
use when it falls out of tolerance limit or requires scheduled calibration?
g. Does your system provide a database of preventative maintenance, calibration, and repair records for
laboratory equipment, preferably supported by standardized reporting?
h. Can your system schedule calibration, verification, and maintenance tasks in the worksheets or work flow
process and make that schedule available for viewing?
i. Does your system allow users to create and edit instrument maintenance profiles?
Requirement
code
Vendor
response
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1.4.7 External system interfaces

1.4.7 External system interfaces
Requirement
code
Vendor
response
a. Does your system support a library of common and/or basic electronic data deliverable (EDD) formats? If so,
which?
b. Can your system transfer data to and from another record management system? If so, how?
c. Does your system integrate with Microsoft Exchange services?
d. Can your system import data from and export data to Microsoft Word, Excel, and/or Access?
e. Can your system interface with non-Microsoft programs? If so, which?
f. Can your system interface with external billing systems? If so, how?
g. Can your system interface with enterprise resource planning (ERP) systems? If so, how?
h. Can your system interface with external contract or reference laboratories to electronically send or retrieve
datasheets, analysis reports, and other related information?
i. Can your system exchange data with National Identification System (NAIS) tracking systems?
j. Can your system generate and exchange data with other systems using Health Level 7 (HL7) standards?
k. Can your system leverage the application programming interface (API) of other systems to establish
integration between systems?
l. Does your system provide a real-time interface for viewing live and stored data transactions and errors
generated by interfaced instruments and systems?
m. Can your system transmit status changes of samples, inventory, equipment, etc. to an external system?
n. Can your system direct output from ad-hoc queries to a computer file for subsequent analysis by other
software?
o. Does your system support the manual retransmission of data to interfaced systems?
p. Does your system support dockable mobile devices and handle information exchange between them and the
system?
q. Does your system support the use of optical character recognition (OCR) software?
1.4.8 Reporting
1.4.8 Reporting
a. Does your system include a versatile report writer and forms generator that can generate reports from any data in
tables? If so, please provide details.
b. Does your system include a custom graphic generator for forms?
c. Does your system interface with a third-party reporting application?
d. Does your system allow the development of custom templates for different types of reports?
e. Does your system maintain template versions and renditions, allowing management and tracking of the template
over time?
f. Can your system generate template letters for semi-annual reports?
g. Does your system support report queries by fields/keys, status, completion, or other variables?
Requirement
code
Vendor
response
h. Does your system use Microsoft Office tools for formatting reports?
i. Does your system support multiple web browsers for viewing online reports? If so, list which ones.
j. Can your system generate, store, reproduce, and display laboratory, statistical, and inventory reports on demand,
including narrative?
k. Does your system include several standard reports and query routines to access all samples with the pending status
through a backlog report that includes the following criteria: all laboratory, department, analysis, submittal date,
collection date, prep test complete, location, project, sample delivery group, and other user-selectable options?
l. Can your system indicate whether a report is preliminary, amended, corrected, or final while retaining revision
history?
m. Does your system support both structured and synoptic reporting?
n. Can your system generate management and turn-around time reports and graphs?
o. Can your system generate customized final reports?
p. Can your system automatically generate laboratory reports of findings and other written documents?
q. Can your system automatically generate individual and aggregate workload and productivity reports on all
operational and administrative activities?
r. Can your system automatically generate and transmit exception trails and exception reports for all entered and/or
stored out-of-specification data?
s. Can your system generate a read-only progress report that allows for printed reports of sample status and data
collected to date?
t. Does your system provide an ad-hoc web reporting interface to report on user-selected criteria?
u. Can your system automatically generate and update control charts?
v. Can your system generate QA/QC charts for all recovery, precision, and lab control samples via a full statistics
package, including Levy-Jennings plots and Westgard multi-rule?
w. Does your system display history of previous results for an analyte's sample point in a tabular report, graphic
trend chart, and statistical summary?
x. Can your system automatically generate and post periodic static summary reports on an internal web server?
y. Does your system transmit results in a variety of ways including fax, e-mail, print, and website in formats like
RTF, PDF, HTML, XML, DOC, XLS, and TXT? Please explain.
z. Does your system electronically transmit results via final report only when all case reviews have been completed
by the case coordinator?
aa. Does your system include a rules engine to determine the recipients of reports and other documents based on
definable parameters?
ab. Does your system allow database access using user-friendly report writing and inquiry tools?
1.4.9 Laboratory management
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1.4.9 Laboratory management

a. Does your system allow the creation, modification, and duplication of user profiles?
b. Does your system allow entry, maintenance, and administration of customers, suppliers, and other outside
entities?
c. Does your system allow the creation, modification, and maintenance of user training records and associated
training materials?
d. Does your system allow the management of information workflow, including notifications for requests and
exigencies?
e. Does your system allow the management of documents like SOPs, MSDS, etc. to better ensure they are current
and traceable?
f. Does your system allow the management and monitoring of resources by analyst, priority, analysis, and
instrument?
g. Does your system allow authorized persons to select and assign tasks by analysts, work group, instrument, test,
sample, and priority?
h. Does your system allow authorized persons to review unassigned work by discipline and by lab?
i. Does your system allow authorized persons to review pending work by analyst prior to assigning additional work?
j. Does your system manage and report on reference samples, reagents, and other inventory, including by
department? If so, to what extent?
k. Does your system automatically warn specified users when inventory counts reach a definable threshold and
either prompt for or process a reorder?
l. Does your system allow authorized users to monitor and report on reference and reagent creation, use, and
expiration?
m. Does your system allow authorized users to search invoice information by invoice number, account number,
accession, payment types, client, or requested diagnostic test(s)?
n. Does your system include performance assessment tracking?
o. Can your system receive, record, and maintain customer and employee feedback and apply tools to track the
investigation, resolution, and success of any necessary corrective action?
p. Does your system monitor proficiency test assignment, completion, and casework qualification for analytical
staff?
q. Does your system provide analysis tools to better support laboratory functions like resource planning,
productivity projections, workload distribution, and work scheduling? Do those tools display information in a
consolidated view, with the ability to drill down to more detailed data? Please explain.
r. Does your system calculate administrative and lab costs?
s. Does your system capture and maintain patient, submitter, supplier, and other client demographics and billing
information for costing, invoicing, collecting, reporting, and other billing activities?
t. Does your system support multiple customer payment sources (e.g. grants}? Please explain the extent.
u. Does your system track number of visits per specific industry?
Requirement
code
Vendor
response
1.5 System-specific
The system-specific addendum can be found here.
1.6 Industry-specific
The industry-specific addendum can be found here.
1.7 Custom requirements

1.7 Custom requirements
Request for information Requirement code Vendor response
a.
b.
c.
d.
e.
f.
g.
h.
i.
h.
i.
j.
References
[1] https:/ / www. mediawiki. org/ wiki/ Extension:Collection
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5. More Laboratory Informatics

Applications
An electronic laboratory notebook (also
known as electronic lab notebook or ELN) is a
software program or package designed to replace
more traditional paper laboratory notebooks.
Laboratory notebooks in general are used by
scientists and technicians to document, store,
retrieve, and share fully electronic laboratory
records in ways that meet all legal, regulatory,
technical and scientific requirements. A
laboratory notebook is often maintained to be a
legal document and may be used in a court of
Alexander Graham Bell's unpublished lab notebook, well before the invention
law as evidence. Similar to an inventor's
of the ELN
notebook, the lab notebook is also often referred
to in patent prosecution and intellectual property
litigation. Modern electronic lab notebooks have the advantage of being easier to search upon, support collaboration
amongst many users, and can be made more secure than their paper counterparts.
History of the ELN

While some credit Dr. Keith Caserta with the concept of an electronic version of the laboratory notebook, it's likely
that others had similar early ideas on how to integrate computing into the process of laboratory note taking.
Significant discussion concerning the transition from a pen-and-paper laboratory notebook to an electronic format
was already in full swing in the early 1990s. During the 206th National Meeting of the American Chemical Society
in August, 1993, an entire day of the conference was dedicated to talking about "electronic notebooks" and ELNs. "A
tetherless electronic equivalent of the paper notebook would be welcomed by the working scientist," noted Virginia
Polytechnic Institute's Dr. Raymond E. Dessy for the conference. Dessy had in the mid-1980s begun postulating on
the idea of an electronic notebook, and by 1994 he provided one of the first working examples of an ELN.
By 1997, a special interest group called the Collaborative Electronic Notebook Systems Association (CENSA)
formed. Supported by 11 major pharmaceutical and chemical companies, the consortium worked with scientific
software and hardware vendors to facilitate the creation of an ELN that met the technical and regulatory needs of its
members. The consortium at that time envisioned a collaborative ELN that "teams of scientists worldwide can use to
reliably capture, manage, securely share, and permanently archive and retrieve all common data and records
generated by research and development and testing labs." That same year development of an enterprise-wide ELN at
Kodak's research facilities in England was in full swing. The Kodak ELN was "implemented as a collection of Lotus
Notes databases and applications," making it arguably one of the first enterprise ELN solutions in use at the time.
In 1998 one of the first web-based versions of an ELN was introduced in the form of the University of Oregon's
Virtual Notebook Environment (ViNE), "a platform-independent, web-based interface designed to support a range of
scientific activities across distributed, heterogeneous computing platforms." This innovation would go on to inspire

vendors in the 2000s to develop web-based thin-client ELNs for laboratories everywhere. Yet it likely wasn't until
the Electronic Signatures in Global and National Commerce Act (ESIGN) in June 2000 that the true legal
implications of a fully electronic laboratory notebook would have on the industry. If an ELN were to be responsible
for providing validation during the patent processes and be valid for other types of audits, a mechanism for
authenticating the origin of the ideas would be necessary. The ESIGN act meant that electronic records could be
authenticated and digital signatures made legally binding, lending further relevancy to ELNs. Instead of searching
through notebooks and piles of documents, printing material, and submitting thousands of pages for an FDA audit,
ELN users could suddenly collate and submit electronic records, saving time and headaches.
Enthusiasm for ELNs began to pick up again in the early 2000s, with a strong case for further data integration into
ELNs being made at the CENSA-supported International Quality & Productivity Center (IQPC) conference in
London during September 2004. During that conference the push for stronger data integration was made, with the
base premise that "ELNs would improve corporate strategy by allowing information to be used more intelligently
with the help of decision-support software." By early 2007, industry-specific ELNs were pushing growth in the
market: Scientific Computing World estimated 83 percent of related organizations declaring interest in ELNs, with
43 percent of those organizations seriously considering an evaluation or purchase.
Despite the beginnings of an economic downturn in the late 2000s, Atrium Research later estimated that ELN's
market potential was around $1.7 billion. During this time scientists and academics traditionally slow to adopt
technological change were gradually warming up to the benefits of an electronic laboratory notebook. Academics
in particular realized the problems the high turnover postdoc rate created in research laboratories. Postodocs would
depart from the university, leaving PIs and directors scratching their heads on where the data ended up. ELNs
changed that, allowing much more persistent data that can be found and referenced even after a postdoc departs.
The movement towards ELN integration into other laboratory functions during the 2000s eventually led to the
blurring of what an ELN actually is. In early 2007 Scientific Computing World reported that the definition of an
ELN varied among scientists, with 35 percent of them stating they were "clear about the difference between a LIMS
and an ELN." Today it's possible to see in some vendors' offerings the formerly distinct entity that was ELN to now
be completely integrated into a LIMS.
Regulations and legal aspects

The laboratory accreditation criteria found in the ISO 17025 standard needs to be considered for the protection and
computer backup of electronic records[citation needed]. These criteria can be found specifically in clause 4.13.1.4 of the
standard.
Electronic lab notebooks used for development or research in regulated industries, such as medical devices or
pharmaceuticals, are expected to comply with U.S. Food and Drug Administration (FDA) regulations related to
software validation. The purpose of the regulations is to ensure the integrity of the entries in terms of time,
authorship, and content. Unlike ELNs for patent protection, the FDA is not concerned with patent interference
proceedings, but rather with avoidance of falsification.
Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et
seq.) and 21 CFR 11. Essentially, the requirements are that the software has been designed and implemented to be
suitable for its intended purposes. Evidence to show that this is the case is often provided by a software requirements
specification (SRS) that lays out the intended uses and needs that the ELN will meet. The SRS typically includes one
or more testing protocols that, when followed, demonstrate that the ELN meets the requirements of the specification
and that the requirements are satisfied under worst-case conditions. Security, audit trails, prevention of unauthorized
changes without substantial collusion of otherwise independent personnel (i.e. those having no interest in the content
of the ELN such as independent quality unit personnel) are all fundamental to the ELN. Finally, one or more reports
demonstrating the results of the testing in accordance with the predefined protocols are required prior to release of
the ELN software for use. If the reports show that the software failed to satisfy any of the SRS requirements, then
90

corrective and preventive action (CAPA) must be undertaken and documented. Such CAPA may extend to minor
software revisions, or changes in architecture or major revisions. CAPA activities need to be documented as well.
Modern features of an ELN

ELNs are generally divided into two categories:
A "specific" ELN contains features designed to work within specific applications, scientific instrumentation, or
data types.
A cross-disciplinary or "generic" ELN is designed to support access to all data and information that needs to be
recorded in a lab notebook.
Among these two general categories are ELNs that capture two particular markets: individual researchers and group
research teams. ELNs can be tailored to one or both types of markets, with both groups and individuals benefiting
from the ELN's inherent ability to add structure to research records. Groups utilizing an ELN typically require two
additional abilities: to share research data and communicate about their research.
Modern features include, but are not limited to:
importation of data which has already been captured elsewhere
direct recording of data in various forms like text, images, and tables
lending of structure to data and information through the use of preformatted or customizable templates which
include a range of field types
creation of links between records
storage of fully searchable records in a secure database format
inclusion of a messaging system for better collaboration
a secure yet flexible environment to protect the integrity of both data and process while allowing for process
changes
generation of secure forms that accept laboratory data input via a computing device and/or laboratory equipment
accommodation for networked or wireless communications
a scheduling option for routine procedures such as equipment qualification and study-related timelines
configurable qualification requirements
ELN vendors
See the ELN vendor page for a list of ELN vendors past and present.
Further reading
LabCompliance News [1]
Taylor, Keith T. (2006). "The status of electronic laboratory notebooks for chemistry and biology" [2] (PDF).
Current Opinion in Drug Discovery & Development 9 (3): 348353. Retrieved 06 May 2011.
References
[1] http:/ / www. labcompliance. com/
[2] http:/ / www. symyx. com/ products/ pdfs/ Electronic_laboratory_notebooks. pdf
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A laboratory execution system or LES is a "computer system employed in the laboratory at the analyst work level
to aid in step enforcement for laboratory test method execution," according to the 2007 Annual Book of ASTM
Standards. The general purpose of the LES is to direct the user to follow specific steps to ensure the rigidity of the
test method and and the process' end results, though alternate workflow routes may be applied in specific
circumstances. The LES may encompass this functionality and more, including tasks like enforcing standard
operating procedures (SOPs), validating calculations and instrument interfaces, and acquiring or importing
procedural data from other systems into one common system.
For some, an LES may be considered a sub-branch of an electronic laboratory notebook (ELN) specifically made for
laboratories engaging in quality control and quality assurance applications, while others may consider it simply a
separate set of functionality which may be found in an ELN or a LIMS. Some in the industry suggest the term
"laboratory execution system" is a vendor-led morphing of the "method execution system," which was originally
designed "to address the problem of standard operating procedure (SOP) compliance."
In France, the English word "Middleware" is used to define a LES.
References

A scientific data management system (SDMS) is a piece or package
of software that acts as a document management system (DMS),
capturing, cataloging, and archiving data generated by laboratory
instruments (HPLC, mass spectrometry) and applications (LIMS,
analytical applications, electronic laboratory notebooks) in a compliant
manner. The SDMS also acts as a gatekeeper, serving
platform-independent data to informatics applications and/or other
consumers.
As with many other laboratory informatics tools, the lines between a
LIMS, ELN, and an SDMS are at times blurred. However, there are
some essential qualities that an SDMS owns that distinguishes it from
other informatics systems:
NIST tests standard interfaces for its lab

equipment. SDMSs allow labs to integrate
equipment data with other types of data.
1. While a LIMS has traditionally been built to handle structured,

mostly homogeneous data, a SDMS (and systems like it) is built to handle unstructured, mostly heterogeneous data.
2. A SDMS typically acts as a seamless "wrapper" for other data systems like LIMS and ELN in the laboratory,
though sometimes the SDMS software is readily apparent.
3. A SDMS is designed primarily for data consolidation, knowledge management, and knowledge asset realization.
[1]
An SDMS can be seen as one potential solution for handling unstructured data, which can make up nearly 75 percent
of a research and development unit's data. This includes PDF files, images, instrument data, spreadsheets, and other
forms of data rendered in many environments in the laboratory. Traditional SDMSs have focused on acting as a
nearly invisible blanket or wrapper that integrate information from corporate offices (SOPs, safety documents, etc.)
with data from lab devices and other data management tools, all to be indexed and searchable from a central
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database. An SDMS also must be focused on increasing research productivity without sacrificing data sharing and
collaboration efforts.
Some of the things a standard SDMS may be asked to do include, but are not limited to[2]:
retrieve worklists from LIMS and convert them to sequence files

interact real-time with simple and complex laboratory instruments
analyze and create reports on laboratory instrument functions
perform complex calculations and comparisons of two different sample groups
monitor environmental conditions and react when base operating parameters are out of range
act as an operational database that allows selective importation/exportation of ELN data
manage workflows based on data imported into the SDMS
validate other computer systems and software in the laboratory
SDMS vendors
See the SDMS vendor page for a list of SDMS vendors past and present.
References
[1] Wood, Simon (2007). "Comprehensive Laboratory Informatics: A Multilayer Approach" (http:/ / www. starlims. com/
AL-Wood-Reprint-9-07. pdf), pp. 3.
[2] Heyward, Joseph E. II (2009). "Selection of a Scientific Data Management System (SDMS) Based on User Requirements" (https:/ /
scholarworks. iupui. edu/ handle/ 1805/ 2000), pp. 15 (PDF).

Sometimes referred to as a chromatography data
system
(CDS),
a
chromatography
data
management system (CDMS) is a set of dedicated
data-collection tools that interface and/or integrate
with a laboratory's chromatography equipment. A
base CDMS will set up a desired methodology to be
used by the chromatography equipment, acquire data
from it, process the acquired data, store the
information in a database, and interface with other
laboratory informatics systems to import and export
files and data.[1]
A liquid chromatography linear ion trap instrument as an example of a

device that may be interfaced with a CDMS
History of the CDMS

The first attempts to automate the analysis of chromatography data through electronics took place in the early 1970s.
These analysis tools utilized microprocessor-based integrators, "dedicated devices for measuring chromatographic
peaks and performing user-specified calculations" which also featured a printer plotter to output the results. Limited
memory plagued those early systems, preventing more than one chromatograph from being stored at any one time.
This became less of problem for large labs with bigger budgets in the mid-70s, as expensive centralized data systems
were installed, allowing greater data storage and sharing capabilities.

As computers shrank in size, the personal computer became a viable reality. In 1980 entrepreneur and
Hewlett-Packard prodigy Dave Nelson saw the potential the personal computer could have on the field of analytical
chemistry, joining with partner Harmon Brown to create Nelson Analytical Inc. That year they developed the first
CDMS personal computer software, soon followed by Turbochrom, the first CDMS system for MS Windows. This
innovation quickly spread from analytical chemistry labs to the fields of environmental, forensic, and pharmaceutical
sciences. At the same time chromatography minicomputers like Hewlett-Packard's 3350 LAS Lab Automation
System and Perkin-Elmer's LIMS 2000 CLAS chromatography laboratory automation system were seeing increased
utilization, featuring the data acquisition and processing of up to 32 or more simultaneous chromatographs.
In the 1990s, more affordable higher-performance PCs combined with tighter networking standards allowed
for networks of CDMSs, especially those installed on personal computers. By the late '90s, the CDMS commonly
featured the ability to set up a methodology and analytical run information, control some instruments, acquire
injection data, process the data in different ways, save the data, and transmit it to other systems like a LIMS. By
2008, CDMS functions were becoming more enhanced, driven by improvements in liquid chromatographs (LC) and
gas chromatographs (GC). The new innovation of high-speed LC and GC instruments meant the potential for faster
data generation, improved seperation, and higher resolutions and sensitivities. While these next-generation machines
would bring more processing power to chromatography labs, it also meant that vendors would have to improve
CDMSs, specifically the analog-to-digital converter sampling rates. Some vendors were estimating at the time that
data acquisition sampling rates on the order of 100 to 300 Hz would be needed to keep up with the new wave of
speedier chromatography devices. Additional concerns of scalability and remote access were becoming important
due to the expansion of pharmaceutical and chemical companies expanding into parts of Latin America, South
America, and the Far East.
CDMS vendors
See the CDMS vendor page for a list of CDMS vendors past and present.
References
[1] McDowall, R.D. (1999). "Chromatography Data Systems I: The Fundamentals" (http:/ / www. 21cfrpart11. com/ files/ library/ compliance/
cds_1. pdf) (PDF), pp. 1-2.
94
95
6. Related Standards and Compliance

21 CFR Part 11
The Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) provides compliance information regarding
the U.S. Food and Drug Administration's (FDA) guidelines on electronic records and electronic signatures. Within
this part, requirements are created to help ensure security, integrity, and confidentially of electronic records and to
ensure electronic signatures are as legally binding as hand-written signatures.
Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech and biologics companies,
contract research organizations, and other FDA-regulated industries, with some specific exceptions, to implement
controls, including audits, system validations, audit trails, electronic signatures, and documentation for closed and
open software and systems involved in processing specific electronic data. This primarily includes data to be
maintained by the FDA predicate rules and data used to demonstrate compliance to a predicate rule. A predicate rule
is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA
regulation other than Part 11. The rule also applies to submissions made to the FDA in electronic format, but not to
paper submissions by electronic methods, though paper submissions may eventually be prohibited by the FDA.
History
By the early 1990s, food and drug manufacturers approached the U.S. Food and Drug Administration (FDA) about
the possibility of electronic submissions with electronic signatures. However, at that time the government did not
allow for digital signatures. In July 1992, the FDA began soliciting comments about the process of using electronic
signatures.
In March 1997, the FDA issued Part 11 regulations which, in the words of the FDA, were "intended to permit the
widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health."
Various keynote speeches by FDA insiders early in the 21st century (in addition to compliance guides and draft
guidance documents) as well as strong efforts by the FDA to motivate industry to move to e-filing resulted in many
companies like Eli Lilly, Agilent Technologies, and other businesses rapidly being forced to change their methods
and systems to adapt to the new standards.
However, many entities expressed concerns about the Title 11 conditions, including concerns the regulations would
"unnecessarily restrict" the use of technology, add significant compliance costs beyond what was intended, and stifle
technological innovation while reducing public health benefit. In November 2002, the FDA released the guidance
document "Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of
Electronic Records" to the public for commenting. On February 3, 2003, the FDA withdrew that document, stating
"we wanted to minimize industry time spent reviewing and commenting on the draft guidance when that draft
guidance may no longer represent our approach under the [current good manufacturing practice] initiative," adding it
would afterwards "intend to exercise enforcement discretion with regard to certain Part 11 requirements." Further
guidance documents were withdrawn later that month, culminating in a final guidance document in August 2003
stating the government body would re-examine Part 11 and make necessary changes. However, the FDA reiterated
despite its retraction of the guidance documents "21 CFR Part 11 is not going away, and neither is the agency's
demand for electronic record integrity." The retraction of guidance and change in policy, however, led many IT
members in the pharmaceutical and life sciences industry in late 2004 to state one of the key problems they face as
the lack of clear guidelines from the FDA about what is required for compliance.
21 CFR Part 11
The FDA had indicated it would produce a revised version of Part 11 by the end of 2006, after its Third Annual FDA
Information Management Summit had concluded. Those revisions never arrived, and little in the way of updates on
the topic arrived. On July 8, 2010, the FDA announced it would begin to audit facilities working with drugs "in an
effort to evaluate industry's compliance and understanding of Part 11 in light of the enforcement discretion," leaving
some to wonder if this was an indicator the regulation and/or its guidance would finally see a revision.
Structure
The structure of Part 11 is as follows:
Subpart A General Provisions
11.1 Scope [1]
11.2 Implementation [2]
11.3 Definitions [3]
Subpart B Electronic Records
11.10 Controls for closed systems [4]
11.30 Controls for open systems [5]
11.50 Signature manifestations [6]
11.70 Signature/record linking [7]
Subpart C Electronic Signatures
11.100 General requirements [8]
11.200 Electronic signature components and controls [9]
11.300 Controls for identification codes/passwords [10]
Subpart A
This is essentially the preamble of the regulations, explaining to what and who the regulations apply as well as how
they'll apply. Definitions of common terms appearing in the regulations can also be found here, including a
clarification in the difference between a digital and electronic signature.
Subpart B
This section covers the requirements applicable to electronic records and their management. Several requirements
are addressed, including "how to ensure the authenticity, integrity, and, when appropriate, the confidentiality of
electronic records"; what content a signature should contain; and how electronic records and their signatures should
be linked. It also covers topics like system validation, data traceability, audit control, and version control.
Subpart C
This final section addresses the requirements specific to electronic signatures and their use. General requirements for
electronic signatures, their components and controls, and password controls are all addressed. Additionally, this
section addresses requirements for more advanced biometric-based signatures.
Audit guidelines and checklist

For those auditing computer systems and IT environments for their compliance with 21 CFR Part 11 and other
regulations, a set of guidelines and checklist items may be useful.
Click the link above for the full set of guidelines and checklist items.
96
21 CFR Part 11
Further reading
"Electronic Code of Federal Regulations - Title 21: Food and Drugs - Part 11: Electronic Records; Electronic
Signatures" [11]. U.S. Government Printing Office.
"CFR - Code of Federal Regulations - Title 21 - Part 11 Electronic Records; Electronic Signatures" [12]. U.S.
Food and Drug Administration.
Huber, Ludwig (15 November 2012). "Tutorial: 21 CFR Part 11 - Electronic Records and Electronic Signatures"
[13]
. LabCompliance.
References
[1]
[2]
[3]
[4]
[5]
[6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ CFRSearch. cfm?fr=11. 1
http:/ / www. ecfr. gov/ cgi-bin/ retrieveECFR?gp=& SID=04a3cb63d1d72ce40e56ee2e7513cca3& r=PART& n=21y1. 0. 1. 1. 8
http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ cfrsearch. cfm?cfrpart=11
http:/ / www. labcompliance. com/ tutorial/ part11/

The following guidelines and checklist items provide a frame of reference for vendors and auditors to better
determine potential compliance issues with Title 21 Code of Federal Regulations Part 11 and a variety of other
regulatory guidelines.
All items in the checklist for general IT controls should also be checked for individual systems, especially where
those systems use different control measures (e.g., they have an independent authentication system).
If this checklist is used by software vendors, then certain elements may or may not apply depending on the
circumstances. For instance, validation is technically the responsibility of the entity acquiring the software.
However, in the case of SaaS, a greater practical responsibility to validate the system may lie with the vendor. In all
cases, the vendor should assume responsibility for ensuring that their software operates as intended within the
targeted environments. Failure to do so may result in a lack of willingness of potential customers to obtain the
system.
References will be provided for each checklist item to indicate where the requirement comes from. These references
are either to the regulation itself, Agency responses in the Final Rule, or from the guidance document "General
Principles of Software Validation; Final Guidance for Industry and FDA Staff" (GPSV).
General IT
Following is a list of questions that either apply to the larger IT environment, or to both the larger environment and
to individual systems. The auditor must be sure to evaluate both where necessary. For instance, an organization may
have a robust password policy which is managed by a centralized identity management tool. This is important
evaluate in terms of general security around the systems in scope. At the same time, the specific system may or may
not leverage the corporate IDM and thus its identity management should be evaluated on its own merits.
97

Computer Systems Validation - 21 CFR 11.10(a)
Does a defined computer system validation policy exist? - 21 CFR 11.10(a)
Are all computer systems involved in activities covered by predicate regulations validated? - 21 CFR 11.10(a), 21
CFR 211.68(b), 21 CFR 820.30(g)
Does the computer system validation cover the current deployed version of the system? - GPSV 4.7
Validation Assessment
Does the software developer have a defined systems development life-cycle (SDLC)? - GPSV 4.4
Does the SDLC reflect a generally recognized life cycle approach? [1]
Is the SDLC followed? - GPSV 4.4
Is the software well documented from a design/development/implementation perspective? - GPSV 3.3
Is there evidence of design review activities (what this entails will depend on the nature of the SDLC - for
instance, Agile methodologies will involve daily standup meetings,while a waterfall approach may reflect
formal design review steps)? - GPSV 3.5
Does the level of validation coverage reflect the risk from system failure? - GPSV 6.1
Is there sufficient level of independence in the validation/verification activities? - GPSV 4.9
Are sufficient resources and personnel provided for software development and validation? - 21 CFR 211.25(c),
21 CFR 820.25(a)
Are records maintained of defects and failures identified in the development process? - GPSV 5.2.6
For any software system, is there a set of approved requirements which drove the design (note: the name can
vary based on the SDLC in use). - GPSV 6.1
For iterative development approaches, are previous versions of deliverables (such as requirements lists)
archived in some fashion? - GPSV 5.2.1
Is there an audit trail for modifications to system documentation? - 21 CFR 11.10(k)(2)
For commercial off-the-shelf (COTS), has the vendor been evaluated for its quality systems? - GPSV 6.3
Is there some form of traceability that permits tracking of test results and verification activities to specific
requirements? - GPSV 5.2.2
Are adequate change control systems in place during the development and implementation processes? GPSV
3.3
For each of the other elements of this checklist that apply directly to an electronic record system, has
appropriate validation work been undertaken to establish that the system complies with the checklist item?
Identity Management Systems

Do any identity management systems have minimum password complexity/strength requirements? Do these
minimums seem reasonable? - 21 CFR Part 11 Final Rule Section 130
Do these id systems have policies regarding password change frequency? - 21 CFR 11.300(b)
Do identity management systems prevent the creation of duplicate user IDs? [2]
Access Controls
Do formal procedures exist governing user account creation for electronic records systems.
Do formal procedures exist governing access to network and server resources that are used to operate electronic
records systems?
98
Cloud Computing Policies[3]

Are policies in place governing the selection and use of cloud vendors for electronic record systems?
Do these policies include Service Level Agreements(SLA's) regarding such things as up time, and support
responsiveness?
Are cloud vendors evaluated for security and compliance with appropriate regulations?
Do policies governing record retention specifically apply to cloud vendors?
Are systems for transmitting electronic records configured to do so in a secure manner? 21 CFR 11.30
Training and Personnel

Is an organizational chart available covering personnel involved in the design, development, administration or use
of electronic records systems?
Are job descriptions available for these individuals, indicating their specific responsibilities regarding electronic
record systems?
Is there a defined training program around authentication practices? Electronic signatures?21 CFR 11.10(i)
Are system administrators and developers trained in Part 11 and related regulations? 21 CFR 11.10(i)
Are users trained on the use of electronic records systems? 21 CFR 11.10(i)
Change Control Systems

Is there a formal change control system for modifications to the production electronic records system? GPSV
5.2.7
Does the change control system require an assessment of impact, risk, and require authorization before
proceeding? GPSV 6.1
Is there a configuration management system in place such that the contents of each version of released software is
archived and readily identifiable? GPSV 5.2.1
Is there a formal change control system for changes to requirements and design elements of the system during the
development process? GPSV 3.3
Do change control systems in use require appropriate approvals as governed by the SDLC model in use?
Electronic Signature Certification

If the organization is using electronic signatures, have they filed a certification with the FDA indicating so? 21
CFR 11.100(c)
Records Retention Policy

Does the organization have a records retention policy covering records per the predicate regulations? 21 CFR
11.10(c)
System Specific
Fraud Detection
Is the system designed to either prevent record alteration or make such alteration apparent? 21 CFR 11.10(a)
99
Audit Trails
Does the system maintain an audit trail that tracks changes to electronic records? 21 CFR 11.10(e)
Are the audit trail records time stamped? 21 CFR 11.10(e)
Are the audit trail records system generated, such that human intervention is not required? 21 CFR 11.10(e)
Are audit trail records secured such that they cannot be modified by users of the system? 21 CFR 11.10(e)
Is the audit trail data available for export (printing or electronic) to support agency review? 21 CFR 11.10(e)
Access Controls
Does the identity management systems have minimum password complexity/strength requirements? Do these
minimums seem reasonable? 21 CFR Part 11 Final Rule Section 130
Do these id systems have policies regarding password change frequency? 21 CFR 11.300(b)
Do identity management systems prevent the creation of duplicate user IDs?
Open Systems Controls[4]

Are records transmitted by the system sent in a secure manner, such that their authenticity, integrity and
confidentiality are ensured? 21 CFR 11.30
Is access to the system appropriately managed to prevent unauthorized external access?
Has the system been evaluated for susceptibility to intrusion?
Is there a system in place to evaluate current IT security threats that have been identified (by the National Cyber
Awareness System via NIST, or other appropriate organization)?
Electronic Signatures
Is the electronic signature system engineered in such a way as to ensure that the signatures cannot be attached to
other records, or cannot be removed from the records they are attached to? - 21 CFR 11.70
Is the system engineered such that in order to apply someone elses signature to a file that collaboration is
required between two or more individuals? (this is largely covered by the identity management controls). - 21
CFR 11.200(a)(3)
If a signature event only requires one signature element, is it only in the case of being part of a continuous period
of system access? - 21 CFR 11.200(a)(1)(i)
Are their suitable loss management procedures in place to address compromised passwords, or lost/stolen
authentication devices (such as RSA ID tokens)? - 21 CFR 11.300(c)
Is the system designed to alert security and/or management in the event of an apparent attempt at unauthorized
use of electronic signatures? Does the system automatically take steps to lock out users associated with these
attempts? - 21 CFR 11.300(d)
Is there a system for the periodic testing of tokens and cards to ensure that they are still operating as expected and
have not been altered? If not, is there something in the nature of the tokens/cards that would render them unusable
should alteration be attempted? - 21 CFR 11.300(e)
Is there a password reset method that does not require system administrators to know a users password? - 21 CFR
Part 11 Final Rule Section 123
Are user passwords suitably encrypted in any persistent data store, such that elucidating the original password
would require extraordinary means?
Are controls in place to ensure that password reset instructions are sent to the correct individual?
100
Export of Records for Agency Review

Does the system support exporting records in a format that is readable by the agency? - 21 CFR 11.10(b)
If the agency hasnt been specifically consulted with regard to acceptable formats, does the system support export
into common formats such as XML or JSON?
Records Retention Support

Does the system have sufficient controls to ensure that the records stored within it will be available throughout the
period specified in the records retention policy? - 21 CFR 11.10(c)
Process Controls
Does the system have a mechanism to establish differing levels of authority to perform tasks in the system? - 21
CFR 11.10(g)
Does the system have a mechanism for preventing steps being taken out of sequence (e.g., signing a record before
data has been entered, or releasing a record before the review step was completed)? - 21 CFR 11.10(f)
Reference material
21 CFR Part 11
11.1 Scope [1]
11.2 Implementation [2]
11.3 Definitions [3]
Subpart B Electronic Records
11.10 Controls for closed systems [4]
11.30 Controls for open systems [5]
11.50 Signature manifestations [6]
11.70 Signature/record linking [7]
Subpart C Electronic Signatures
11.100 General requirements [8]
11.200 Electronic signature components and controls [9]
11.300 Controls for identification codes/passwords [10]
General Principles of Software Validation

The full name of this FDA guidance document is "General Principles of Software Validation; Final Guidance for
Industry and FDA Staff," referenced on here as "GPSV."
Section 1. Purpose [5]
Section 2. Scope [6]
2.1. Applicability
2.2. Audience
2.3. The Least Burdensome Approach
2.4. Regulatory Requirements for Software Validation
2.4. Quality System Regulation vs Pre-Market Submissions
101

Section 3. Context for Software Validation [7]
3.1. Definitions and Terminology
3.1.1 Requirements and Specifications
3.1.2 Verification and Validation
3.1.3 IQ/OQ/PQ
3.2. Software Development as Part of System Design
3.3. Software is Different from Hardware
3.4. Benefits of Software Validation
3.5 Design Review
Section 4. Principles of Software Validation [8]
4.1. Requirements
4.2. Defect Prevention
4.3. Time and Effort
4.4. Software Life Cycle
4.5. Plans
4.6. Procedures
4.7. Software Validation After a Change
4.8. Validation Coverage
4.9. Independence of Review
4.10. Flexibility and Responsibility
Section 5. Activities and Tasks [9]
5.1. Software Life Cycle Activities
5.2. Typical Tasks Supporting Validation
5.2.1. Quality Planning
5.2.2. Requirements
5.2.3. Design
5.2.4. Construction or Coding
5.2.5. Testing by the Software Developer
5.2.6. User Site Testing
5.2.7. Maintenance and Software Changes
Section 6. Validation of Automated Process Equipment and Quality System Software [10]
6.1. How Much Validation Evidence Is Needed?
6.2. Defined User Requirements
6.3. Validation of Off-the-Shelf Software and Automated Equipment
102
Others
21 CFR Part 211 [11]: Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 820 [12]: Quality System Regulation
References and footnotes

[1] While the Agency specifically does not recommend an SDLC, and rightfully so, established SDLC approaches become established typically
due to the quality of product that comes from them. An SDLC that is either unique or a blend of disparate approaches may merit additional
attention on the part of the auditor
[2] Although the regulation only specifies that identification codes in combination with passwords must be unique, since passwords are typically
stored in encrypted format, there is no practical way to do this outside of ensuring that user ID's are unique
[3] In general there was little anticipation when Part 11 was drafted that such a thing as the cloud would come to exist. These checklist items,
therefore, are reasonable extensions of requirements for in house systems.
[4] The field of IT security has exploded in recent years with a number of high profile breaches. At the time of the writing of Part 11, the internet
was much safer in this regard than it is today. The auditor should focus significant effort on security around all systems, but especially open
systems.
[5] http:/ / www. fda. gov/ medicaldevices/ deviceregulationandguidance/ guidancedocuments/ ucm085281. htm#_Toc517237928
[11] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ cfrsearch. cfm?cfrpart=211
[12] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ cfrsearch. cfm?cfrpart=820
40 CFR Part 3
The Title 40 Code of Federal Regulations Part 3 (40 CFR Part 3) sometimes referred to as the Cross-Media
Electronic Reporting Rule (CROMERR) provides for electronic reporting (in lieu of a paper document) to the
U.S. Environmental Protection Agency (EPA). Within this part, requirements are created to ensure that electronic
reporting to the EPA is enacted in a satisfactory way to satisfy federal or authorized program reporting requirements,
including those requiring an electronic signature.
History
On August 31, 2001, the EPA "published a notice of proposed rulemaking, announcing the goal of making electronic
reporting and electronic recordkeeping available under EPA regulatory programs." However, the EPA had been
working on plans related to such a proposal (referred to as Cross-Media Electronic Reporting) well before, stating in
its review of its final rule that the process actually "reflects more than ten years of interaction with stakeholders,"
including "electronic reporting pilot projects conducted with state agency partners, including the States of
Pennsylvania, New York, Arizona, and several others." This also involved collaboration with more than half of U.S.
states in May 1997 on the State Electronic Commerce/Electronic Data Interchange Steering Committee (SEES) and a
series of conferences starting in 1999 to acquire stakeholders' thoughts. Public commenting closed on February 27,
2002, with the EPA receiving 184 collection of written comments. The EPA made additional adjustments to the
proposal, which culminated in a final version of CROMERR that was codified into Title 40 as Part 3 on October 13,
2005 and made effective January 11, 2006.
On December 24, 2008, minor adjustments were made to CROMERR that extended compliance dates for existing
systems making the transition to electronic filing to the EPA.
103
40 CFR Part 3
Structure
The structure of Part 3 is as follows:
3.1 Who does this part apply to? [1]
3.2 How does this part provide for electronic reporting? [2]
3.3 What definitions are applicable to this part? [3]
3.4 How does this part affect enforcement and compliance provisions of Title 40? [4]
Subpart B Electronic Reporting to EPA
3.10 What are the requirements for electronic reporting to EPA? [5]
3.20 How will EPA provide notice of changes to the Central Data Exchange? [6]
Subpart C [Reserved]
Subpart D Electronic Reporting Under EPA-Authorized State, Tribe, and Local Programs
3.1000 How does a state, tribe, or local government revise or modify its authorized program to allow
electronic reporting? [7]
3.2000 What are the requirements authorized state, tribe, and local programs' reporting systems must meet?
[8]
Appendix 1 to Part 3 Priority Reports [9]
Subpart A
This is essentially the preamble of the regulations, explaining to what and who the regulations apply as well as how
they'll apply. Definitions of common terms appearing in the regulations can also be found here, including a
description of electronic signature devices.
Subpart B
This section covers the requirements applicable to electronic record formats and their submission to the EPA's
Central Data Exchange (CDX) or other related EPA systems. It also provides guidelines on how the EPA will notify
CDX users of hardware and software changes that affect transmission.
Subpart C
Subpart C is blank, "reserved for future EPA electronic recordkeeping requirements."
Subpart D
This final section provides in-depth requirements for revising state, local, and tribal government programs for
electronic submissions as well as outlining the reporting system requirements. In particular it lays out a list of
requirements for data generated from electronic document receiving systems, including security, audit trail, quality
control, and electronic signatures.
104
40 CFR Part 3
Central Data Exchange

The EPA's Central Data Exchange (CDX) is used by EPA offices, local and state governments, private industries,
and Indian tribes required to submit environmental data related to more than 60 programs in the United States,
including the Greenhouse Gas Reporting Program, the RadNet program, and the Verify engine and vehicle
compliance program. The EPA touts CDX as an important component of operations as well as meeting 40 CFR Part
3 compliance, claiming reductions in reporting burdens, cost, and data transfer times as well as increases in data
quality and compliance.
As of mid-February 2015, the CDX had more than 296,000 registered users submitting data to 63 data feeds, with 10
additional data flows in development.
Further reading
CROMERR Fact Sheet [10] (PDF)
"Cross-Media Electronic Reporting" [11]. Federal Register. OFR/GPO. 13 October 2005.
"CROMERR 101: Fundamentals for States, Tribes, and Local Governments" [12] (PDF). U.S. Environmental
Protection Agency.
References
[1] http:/ / www. ecfr. gov/ cgi-bin/ text-idx?c=ecfr& sid=5ff3a0efed913ef8fae9e225869688a2& rgn=div5& view=text& node=40:1. 0. 1. 1. 3&
idno=40#se40. 1. 3_11
idno=40#se40. 1. 3_12
idno=40#se40. 1. 3_13
idno=40#se40. 1. 3_14
idno=40#se40. 1. 3_110
idno=40#se40. 1. 3_120
idno=40#se40. 1. 3_11000
idno=40#se40. 1. 3_12000
idno=40#ap40. 1. 3_12000. 1
[10] http:/ / www. epa. gov/ CROMERR/ documents/ cromerr_fact_sheet. pdf
[11] https:/ / www. federalregister. gov/ articles/ 2005/ 10/ 13/ 05-19601/ cross-media-electronic-reporting
[12] http:/ / www. epa. gov/ cromerr/ training/ cromerr101/ cromerr_course_summary. pdf
105

The Good Automated Laboratory Practices (GALP) was a U.S. EPA-based conglomeration of "regulations,
policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of
laboratory data." GALP is considered an expired policy by the EPA, though the true expiration date is not know.
History
Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing good laboratory practice
(GLP) requirements to what they saw as a state of increasing automation in laboratories. An additional revision was
released in 1995 by the EPA.
The GALP's creation was based on six principles:
1. The system must provide a method of assuring the integrity of all entered data.
2. The formulas and decision algorithms employed by the system must be accurate and appropriate.
3. An audit trail that tracks data entry and modifications to the responsible individual is a critical element in the
control process.
4. A consistent and appropriate change-control procedure capable of tracking the system operation and application
software is a critical element in the control process.
5. Control of even the most carefully designed and implemented system will be thwarted if appropriate user
procedures are not followed.
6. Consistent control of a system requires the development of alternative plans for system failure, disaster recovery,
and unauthorized access.
Impact
GALP had a variable regulatory impact on laboratories and organizations early on. Pharmaceutical and biologics
laboratories could practically ignore the regulations while the U.S. Food and Drug Administration (FDA) and EPA
used GALP as a key guiding factor in its standards and contract renewal considerations. The Department of Energy
and Superfund programs tightly followed GALP's standards while others viewed GALP as something to be loosely
interpreted.
References
106

(GAMP) is both a technical subcommittee of the
International
Society
for
Pharmaceutical
Engineering (ISPE) and a set of guidelines for
manufacturers and users of automated systems in
the pharmaceutical industry. One of the core
principles of GAMP is that quality cannot be
tested into a batch of product but must be built
into each stage of the manufacturing process. As a
result, GAMP covers all aspects of production;
from the raw materials, facility and equipment to
the training and hygiene of staff.
GAMP is largely about automated system
validation. In October 2014, Irish tech company
Dataworks Ltd. described it as such:
It is a formal process of thorough
documentation, testing, and logical
process steps that validate clients'
required specifications. The process
begins with a user requirements
specification for the machine, from
which a functional requirement and a
The area of automated pharmaceutical manufacturing is influenced in part
design specification are created.
by GAMP and its associated guidelines.
These documents then form the basis
for the traceability matrix and for the
formal testing of internal acceptance, factory acceptance, and site acceptance. Categorising software is
used to support the approach to validation based on the difficulty and individuality of the computerised
system.
History
GAMP's origins can be traced to the United Kingdom in 1988, when software developers David Forrest and Colin
Jones, through their company FJ Systems, developed real-time control and production information management
control systems for pharmaceutical manufacturers. They worked with ICI Pharmaceuticals' Tony Margetts on the
problem of validating systems that were increasingly becoming more software-based than mechanical- and
electrical-based. This culminated in a five-page document called VMAN I, mapping the older installation
qualification (IQ), operational qualification (OQ), and performance qualification (PQ) phases of equipment
validation to a more modern software validation lifecycle. A second version was created upon additional feedback.
GAMP itself was eventually founded in 1991 (with the previously mentioned Margetts as chairman of the editorial
board) to deal with the evolving U.S. Food and Drug Administration expectations for Good Manufacturing Practice
(GMP) compliance of manufacturing and related systems. GAMP published its first draft guidance in February 1994,
with version 1.0 of it arriving in March 1995. Soon afterwards the organization entered into a partnership with ISPE,
formally becoming part of ISPE in 2000. GAMP 4 was released a year later, followed by GAMP 5 in 2008. GAMP
has enjoyed the support of numerous regulatory authorities over the years spanning the United States, Europe, and
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Japan and is now a recognized good practice worldwide.
Publications
GAMP 5
ISPE has published a series of good practice guides for the industry on several topics involved in drug
manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation
of Automated Systems in Pharmaceutical Manufacture. The last major revision (GAMP 5) was released in February
2008.
The guidance generally states that pharmaceutical computer systems should be built with several key ideas in mind:
1. Make product and process understanding clear.
2. Approach the life cycle from the standpoint of a quality management system.
3. Make life cycle activities scalable.
4. Ensure quality risk management is science-based.
5. Leverage supplier involvement into the system.
System categorization
Software systems borne from these principles can be categorized into one of four GAMP 5 categories. These
classifications act as built-in risk and difficulty assessments that support different validation approaches:
Category 1: Infrastructure software - This includes "established or commercially available layered software" and
"infrastructure software tools" that are themselves validated from within rather than from the infrastructure.
Category 3: Non-configured products - This includes "software that is used as installed" and potentially "software
that is configurable (category 4) but is used either unconfigured or with the standard defaults provided by the
software supplier."
Category 4: Configured products - This includes products where "the user has the means and knowledge to change
the functionality of the device in a way that changes the results outputted by the device. As a direct consequence, this
triggers increased validation effort."
Category 5: Custom applications - This includes any "application, module, user-defined program, or macro" that has
been written in-house or by a third party that "needs to be specified, version controlled, built, and tested (including
integration testing with the commercial application, as applicable) as a minimum to ensure the quality of the
software."
Note: "Category 2: Firmware" was removed from GAMP with revision five.
Other guides
As of February 2015, the ISPE has 13 guides, the latest published in October 2014, titled A Risk-Based Approach to
Regulated Mobile Applications.
External links
International Society for Pharmaceutical Engineering (ISPE) website [1]
GAMP 4 guide [2] (PDF)
GAMP 5 guide [3]
108
References
[1] http:/ / www. ispe. org
[2] http:/ / www. ssfa. it/ allegati/ GDL_GIQAR_GCP_GampGuidelineMilano06. pdf
[3] http:/ / www. slideshare. net/ ProPharmaGroup/ overview-of-computerized-systems-compliance-using-the-gamp-5-guide
Health Insurance Portability and Accountability

Act
The Health Insurance Portability
and Accountability Act of 1996
(HIPAA) was enacted by the United
States Congress and signed by
President Bill Clinton in 1996. Its
intended purpose was "to improve
portability and continuity of health
insurance coverage in the group and
individual markets; to combat waste,
fraud, and abuse in health insurance
and health care delivery; to promote
the use of medical savings accounts; to
improve access to long-term care services and coverage; [and] to simplify the administration of health insurance."
History
Initial
In 1994, U.S. President Bill Clinton attempted to overhaul the national health care system but didn't receive the
support he needed. In 1995, Senators Nancy Kassebaum (R-KS) and Edward Kennedy (D-MA) introduced a
comparatively pared down proposal called the Health Insurance Reform Act of 1995 (S 11028), later referred to
informally as the Kassebaum/Kennedy Bill. The proposal called for health insurance portability for employees,
medical savings accounts, increased deductibility of health insurance for the self-employed, and tax breaks for
long-term care insurance. The legislation successfully made it out of the Senate Labor and Human Resources
Committee on August 2, 1995, only to be stalled "because of opposition from conservative senators who shared
industry concerns over the group-to-individual portability provisions."
With desire to get some sort of health care reform legislation passed, Clinton referenced the stalled bill in his January
1996 State of the Union address on several occasions. Though some feared the ploy by Clinton would ultimately sink
the bill, it inevitably resulted in bipartisan cooperation so no one side could take credit for the bill. On February 7,
1996, the two parties agreed to further discuss the legislation in the House and Senate. This resulted in several
events: the House of Representatives created an alternative bill (HR 3103) that drew on characteristics of S 11028,
passing on March 28; the Senate passed a version of the original S 11028 on April 23 but without controversial
attachments like medical savings accounts. However, differences between the House and Senate bills caused
problems. "The House bill, for example, included provisions allowing for medical savings accounts, a limit on
monetary damages in medical malpractice lawsuits and a reduction in states' authority to regulate health insurance
purchasing pools created by small businesses." Additionally, a provision on mental health coverage was found on the
Senate bill that was omitted from the House version. It took several weeks of debating to make concessions on these
topics.
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A Republican-led compromise was offered on June 10, however debate raged on. It wasn't until a July 25
compromise between Kennedy and Ways and Means Committee Chairman Bill Archer (R-TX) on medical savings
accounts that momentum shifted. Provisions on mental illness and medical malpractice were eventually dropped
from the proposal on July 31, with both House and Senate agreeing on the final version on August 1 and August 2
respectively. On August 21, 1996, the legislation was signed into law by President Clinton and codified as Public
Law 104-191, the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Amendments
The administrative simplification provisions in HIPAA meant more work had to be done in regards to the legislation.
The U.S. Department of Health and Human Services (HHS) began work on the HIPAA Privacy Rule in 1999,
"which set out detailed regulations regarding the types of uses and disclosures of personally identifiable health
information that are permitted by the covered entities." However, large volumes of comments and Executive branch
changes in 2000 slowed the process down. Several more years of corrections and requests for comments followed,
culminating in the release of the Final Rule on August 14, 2002 as 45 CFR Part 160 and Subparts A and E of Part
164. Most health plans were expected to be in compliance by April 14, 2003, though some exceptions existed.
Despite the Privacy Rule, many still argued that the legislation wasn't suitable enough to prevent mishandling of
personal health information and that it was impeding research. These concerns mixed with few incidents of
enforcement in the first few years after the 2003 compliance date prompted additional review by the HHS. On
February 16, 2006, HHS issued the Final Rule regarding HIPAA enforcement, to be effective March 16, 2006.
Additional updates to the enforcement rule came with the Health Information Technology for Economic and Clinical
Health (HITECH) Act, enacted on February 17, 2009. The Act added "several provisions that strengthen the civil
and criminal enforcement of the HIPAA rules" by adding categories of violations and tier levels of penalty amounts.
HIPAA and the HITECH statutes were further revised in January 2013 (effective March 26, 2013) "to strengthen the
privacy and security protection for individuals health information," update the Breach Notification Rule, "strengthen
the privacy protections for genetic information," and revise other portions of HIPAA rules "to improve their
workability and effectiveness."
Structure
HIPAA is divided into five titles, each with their own subtitles:
Title I: Health Care Access, Portability, and Renewability
Subtitle A - Group Market Rules
Subtitle B - Individual Market Rules
Subtitle C - General and Miscellaneous Provisions
Title II: Preventing Health Care Fraud and Abuse; Administrative Simplification; Medical Liability Reform
Subtitle A - Fraud and Abuse Control Program
Subtitle B - Revisions to Current Sanctions for Fraud and Abuse
Subtitle C - Data Collection
Subtitle D - Civil Monetary Penalties
Subtitle E - Revisions to Criminal Law
Subtitle F - Administrative Simplification
Subtitle G - Duplication and Coordination of Medicare-Related Plans
Title III: Tax-Related Health Provisions
Subtitle A - Medical Savings Accounts
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Subtitle B - Increase in Deduction for Health Insurance Costs of Self-Employed Individuals
Subtitle C - Long-Term Care Services and Contracts
Subtitle D - Treatment of Accelerated Death Benefits
Subtitle E - State Insurance Pools
Subtitle F - Organizations Subject to Section 833
Subtitle G - IRA Distributions to the Unemployed
Subtitle H - Organ and Tissue Donation Information Included With Income Tax Refund Payments
Title IV: Application and Enforcement of Group Health Plan Requirements
Subtitle A - Application and Enforcement of Group Health Plan Requirements
Subtitle B - Clarification of Certain Continuation Coverage Requirements
Title V: Revenue Offsets
Subtitle A - Company-Owned Life Insurance
Subtitle B - Treatment of Individuals Who Lose United States Citizenship
Subtitle C - Repeal of Financial Institution Transition Rule to Interest Allocation Rules
Description
Title I of HIPAA contains three subtitles that protect health insurance coverage for workers and their families when
they change or lose their jobs.
Title II of HIPAA contains seven subtitles. One of the most important for expanding HIPAA is Subtitle F, the
Administrative Simplification (AS) provisions, requiring the establishment of national standards for electronic health
care transactions and national identifiers for providers, health insurance plans, and employers. Title II also addresses
the security and privacy of health data, with the intent of improving the efficiency and effectiveness of the nation's
health care system by encouraging the widespread use of electronic data interchange in the U.S. health care system.
Title III of HIPAA modifies the Internal Revenue Code (IRC) to revise available tax deductions for health insurance,
clarify how pre-tax money could be applied health payments, and regulate long-term care services and how they're
contracted. Other tax-related issues like IRA distribution and organ donor tax refund payments are covered by this
title, in total spread out over eight subtitles.
Title IV of HIPAA modifies both the IRC and the Public Health Service Act (PHSA) to describe requirements for
and enforcement of how group health plans could legally manage and cover patients' pre-existing conditions as well
as their continuation of coverage. This information is supplied over two subtitles.
Title V of HIPAA contains three subtitles that amend the IRC concerning miscellaneous issues such as interest
deductions on loans related to company-owned life insurance, how individuals who lose their U.S. citizenship shall
be treated tax-wise, and the removal of certain limitations on interest allocation.
Enforcement
On February 16, 2006, HHS issued the Final Rule regarding HIPAA enforcement. It became effective on March 16,
2006. The Enforcement Rule set civil money penalties for violating HIPAA rules and established procedures for
investigations and hearings for HIPAA violations. Before the enforcement rule, the deterrent effects of the legislation
seemed negligible, with few prosecutions for violations. Enforcement operations were ratcheted up further with the
passage of the Health Information Technology for Economic and Clinical Health Act (HITECH) in 2009, which
greatly increased the financial penalties that could be applied to entities in non-compliance.
By the end of 2014, the U.S. Department of Health and Human Resources (HHS) reported investigating 106,522
HIPAA complaints against national pharmacy chains, major health care centers, insurance groups, hospital chains
111

and other small providers since April 2003. The HHS reported 23,314 of those cases had been resolved by requiring
changes in privacy practice or by corrective action. 10,566 cases were investigated and found that HIPAA was
followed correctly. Another 68,412 cases were found to be ineligible for enforcement because, for example, a
violation occurred before HIPAA became effective, a case was withdrawn by the pursuer, or an activity did not
actually violate the rules.
According to the HHS, the most commonly investigated compliance issue, by order of frequency, have been:
1.
2.
3.
4.
5.
incorrectly used or revealed protected health information (PHI);

insufficient protection mechanisms for PHI;
insufficient mechanisms for patients to access their PHI;
insufficient administrative protections and tools for managing electronic PHI; and
usage and disclosure of more PHI than minimally necessary.
The HHS also stated the entities most likely to be responsible for infractions, by order of frequency, have been:
1.
2.
3.
4.
5.
private practices;
general hospitals;
outpatient facilities;
pharmacies; and
health plans (group health plans and health insurance issuers).
Assessed impact
The enactment of HIPAA caused major changes in the way physicians and medical centers operate. The complex
legalities and potentially stiff penalties associated with HIPAA, as well as the increase in paperwork and the cost of
its implementation, were causes for concern among physicians and medical centers. Many of those concerns were
expressed in an August 2006 paper published in the journal Annals of Internal Medicine. It mentioned a University
of Michigan study that demonstrated how the implementation of the HIPAA Privacy rule resulted in a drop from 96
percent to 34 percent in the proportion of follow-up surveys completed by study patients being followed after a heart
attack.
By 2013, views on the impact of HIPAA were mixed. Leon Rodriguez, director of the HHS' Office for Civil Rights
said of HIPAA:
Whereas many thought HIPAA would "bankrupt" healthcare, shut down research, and otherwise
paralyze the industry, instead the industry has learned the benefits of the transaction and code set
standards through the ease of electronic transactions. And the balance of the [HIPAA] Privacy and
Security protections have paved the way to real benefits for consumers through greater access to quality
care.
In an article for the Houston Chronicle, writer and business consultant Lisa Dorward stated the following for patients
requesting personal health information:
Direct cost to patients is minimal; health care institutions can charge the patient only for copying and
postage costs for delivery of the documents. On the other hand, costs to health care providers are high
and can strain already overburdened budgets. Some clinics and hospitals have had to reconstruct or
remodel existing registration areas to comply with HIPAA's privacy regulations.
Writing for the Loyola Consumer Law Review, attorney and legal writer Anna Colvert wrote:
Generally, HIPAA is considered a step in the right direction regarding patient privacy, and it has
resulted in more descriptive and detailed privacy policies; however, it has not improved the online
privacy practices of these organizations. While HIPAA is a solid foundation in protecting patients
healthcare information there is more work to be done..."
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A May 2013 Computerworld reported on a survey conducted by the Ponemon Institute that found 51 percent of
respondents believed "HIPAA compliance requirements can be a barrier to providing effective patient care" and 59
percent "cited the complexity of HIPAA requirements as a major barrier to modernizing the healthcare system."
Audit guidelines and checklist

For those auditing computer systems and IT environments for their compliance with the Health Insurance Portability
and Accountability Act and other regulations, a set of guidelines and checklist items may be useful.
Click the link above for the full set of guidelines and checklist items as they relate to HIPAA.
Further reading
"Public Law 104 - 191 - Health Insurance Portability and Accountability Act of 1996" [1]. U.S. Government
Publishing Office.
"S. 1028 (104th): Health Insurance Reform Act of 1995" [2]. GovTrack.us. Civic Impulse, LLC.
"Bill Makes Health Insurance Portable" [3]. CQ Almanac 1996 52: 6-286-39. 1997.
References
[1] http:/ / www. gpo. gov/ fdsys/ pkg/ PLAW-104publ191/ content-detail. html
[2] https:/ / www. govtrack. us/ congress/ bills/ 104/ s1028
[3] http:/ / library. cqpress. com/ cqalmanac/ document. php?id=cqal96-1092479
Health Insurance Portability and Accountability

Act/Audit guidelines and checklist
The following guidelines and checklist items provide a frame of reference for vendors and auditors to better
determine potential compliance issues with the Health Insurance Portability and Accountability Act and a variety of
other regulatory guidelines.
The following checklist is focused largely on computerized systems that house Protected Health Information (PHI)
under the HIPAA regulations. However, since the computerized system exists as part of a complete operation, even
when it is hosted by a Cloud provider, the checklist covers the majority of the regulation. This notion of the
requirements of the entire regulation applying even to Cloud companies is particularly underscored with the
HITECH modifications to the HIPAA regulations where Business Associates are now entirely responsible with
adherence to the HIPAA privacy regulations and not merely on a contractual basis.
Administrative safeguards
Security Management Process
Does a detailed risk assessment exist regarding potential vulnerabilities to the confidentiality, integrity, and
availability of PHI?
Does the assessment identify actions to mitigate certain risks? Have these actions been taken, or have plans been
generated to take these actions?
Does a policy exist specifying sanctions to be taken against employees who fail to comply with security policies
and procedures?
Is there a system in place for regular review of system activity, including things such as audit logs and incident
reports?
113

Assigned security responsibility
Is there a formally identified individual who is responsible for developing and implementing security policies?
Has this individual, or the individual's direct reports, developed and implemented security policies?
Collect evidence of security policies being implemented (group policy reports for the AD server, for instance)
Workforce security and Information Access Management
Do procedures exist governing access to PHI by employees?
Are employees who should not have access to PHI prevented from accessing it?
If employees are permitted to access systems that contain PHI, but are not permitted to access PHI, does the
system have suitable controls to prevent that access?
View system accesses by both individuals who have access to PHI and those who don't, and evaluate potential
areas of weakness in the security measures.
Do processes exist for authorizing access to PHI? Do these processes seem reasonable.
Are employees who have access to PHI supervised appropriately? Do their supervisors have adequate training and
understanding regarding the treatment of PHI?
Are adequate procedures in place governing the termination of employees with access to PHI?
Do these procedures include appropriately times termination of accounts (i.e., in the case of involuntary
termination, is the account terminated before the employee might have the opportunity to cause harm?).
For voluntary terminations, are procedures in place that require the supervisor to evaluate the need for continued
access to PHI prior to the departure of the employee in question?
Is there a clear requirement for communication with system administrators and IT staff regarding affected
accounts?
If a health clearinghouse is part of a larger organization, confirm that adequate controls exist that prevent the
larger organization from accessing PHI.
Do the PHI access procedures apply to the IT/IS organization? That is, is access to PHI only allowed for IT/IS
employees with a legitimate business reason to access that data? Are IT/IS employees adequately trained in the
HIPAA regulations, internal policies and procedures regarding PHI?
Security Awareness and Training
Is there a formal and documented training program for employees who deal with PHI?
Are employees provided training on principles of security?
Are there procedures in place for addressing malicious software, including it's detection and reporting? Are
employees prevented from accessing remote sites that are at high risk for containing malicious software?
Is there a system for ensuring that security protection software (in particular anti-virus programs, and firewalls)
are updated periodically?
For outward facing applications, is there a process by which security flaws in components (such as Java) are
identified and fixed.
For systems that provide access to PHI, do they track log-ins, and in particular failed logins?
Does the system lock out users after a specified number of failed logins?
Are system administrators notified if such an event occurs?
Is there evidence that administrators respond to such events in an appropriate manner?
Are there policies governing password complexity, change and reuse frequency? Are the policies consistent with
current "standards" within the industry?
Are employees trained to maintain strict secrecy regarding their passwords?
Are there procedures mandating that IT may not request passwords from users?
114

Security Incident Procedures
Are procedures in place for responding to security incidents?
Is there evidence that these procedures are being followed (review any logs/files regarding actions taken in
response to security incidents).
Contingency Plan
Does the organization have a comprehensive disaster preparedness/business continuity plan?

Does the plan included a backup and recovery procedure for all system data?
Does the plan adequately address how operations can be continued under various scenarios?
Does the plan include procedures for testing the various elements of the plan to ensure they are still valid?
Does the plan address the criticality of the various systems in its design?
Evaluation
Is a periodic re-evaluation of security standards undertaken?
Does the re-evaluation take into account changes in the current state of IT security and the environment of threats
facing secured systems, as well as the current state of the regulations?
Business Associate Agreements
If components of the system are held outside the direct control of the company, such that PHI will be outside of
the direct control of the company, do sufficient agreements exist to guarantee that the party responsible for
handling the PHI will adhere to the requirements of the regulation?
Are these agreements in such a form that they qualify as a contract or equivalent?
Physical safeguards
Facility Access Controls
Is the facility containing the system (this includes electronic access points that connect to the system in a
"non-secure" manner) sufficiently protected from unauthorized access?
Is access to application and database servers further restricted to only those personnel who are authorized to
directly interact with those elements of the system (i.e., system administrators).
Is there a system that limits access to facilities and areas within facilities to authorized personnel? Does this
system implement a mechanism for confirming the identify of individuals accessing the facility (e.g., through a
electronic key access system)
Does this system apply to visitors as well?
Is access to systems used for testing and revision of software similarly restricted? Evaluate the access restrictions
to tools that could be used to modify and deploy the software. Ensure that these access restrictions are addressed
via SOP.
115

Workstation Use
Do procedures exist which govern the class of workstation that can be used to access PHI?
Workstation Security
Are workstations that are used to access PHI appropriately restricted?
If workstations can directly interact with PHI without additional controls, are the workstations secured in
appropriately restricted areas?
Device and Media Controls
Are procedures in place governing the use and removal of hardware and storage media used to house PHI?
Do the procedures seem reasonable?
Do procedures exist regarding the disposal of media and devices used to store PHI?
Are records maintained that account for the movement of such media, and who moved it?
Technical safeguards
Access Control
Do systems with access to PHI have a robust authentication process for gaining access?
Do these system require that all users have a unique id?
Are password assignment, change, recovery, and related processes designed in such a way so as to ensure that the
user gaining access to PHI is who they say they are?
Is there a mechanism for gaining access to necessary PHI in the event of an emergency? Is this mechanism
designed such that it's invocation during non-emergencies would not be achievable in a non-obvious way?
Does this system automatically log off users after a defined period of inactivity?
Does the system maintain PHI in an encrypted state?
Audit Controls
Do systems used for PHI maintain audit trails which record, in a secure manner, all activities within the system.
Are the audit trails reviewed periodically?
Integrity
Are policies and procedures in place to ensure that PHI has not been altered or destroyed in an unauthorized
manner?
Are electronic mechanisms employed to corroborate that PHI has not been altered or destroyed in an unauthorized
manner?*
If PHI is transmitted outside of the responsible entity (i.e., via the internet), is the data transmitted in such a way
so as to prevent unauthorized access (via ssl or similar protocols?)
Are security certificates on servers involved in managing PHI current, and authenticated by a recognized third
party certifying organization?
116
Organizational requirements
Business associate contracts
Are business associates required contractually to adhere to the regulations with regard to PHI they maintain?
Do business associate agreements exist with third party data/application hosting services?
Do business associate agreements extend, contractually, to agents/subcontractors?
Is it clear within the terms of the business associate agreements that the business associate must immediately
report any breaches or incidents?
Is it clear within the terms of the business associate agreements that the relationship can be terminated if the
associate fails to comply with the requirements of the regulations?
Do records exist of audits and other reviews of business associates? If breeches or violations of the regulation
have occurred, have appropriate actions been taken, up to and including termination of the agreement?
Documentation requirements
Documentation
Are the procedures required by the regulations maintained in written (or alternatively electronic, but signed)
form?
Are actions and activities which are required to be documented maintained in written form (or electronic
alternatives)?
Is there a retention policy regarding the policies and procedures? Does the policy require that such documents be
maintained for at least 6 years after either the date of its creation or of its effective date (whichever is later)?
Does a review system exist for these policies and procedures to ensure that they are current?

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 is a United States federal statute and
regulatory standards program that applies to all clinical laboratory testing performed on humans in the United States,
except clinical trials and basic research.
History
On December 5, 1967, the U.S. enacted Public Law 90-174, which included in Section 5 the "Clinical Laboratories
Improvement Act of 1967." CLIA '67 set regulations on the licensing of clinical laboratories and the movement of
samples in and out of them across state lines. Laboratories would be eligible for a full, partial, or exempt CLIA-67
license, depending on the laboratory's conducted tests.
However, by the mid-1980s the relevancy of CLIA '67 to a vastly changed procedural and technological clinical
laboratory landscape began to be questioned. The Office of the Assistant Secretary for Health for Planning and
Evaluation (ASPE) of the U.S. Department of Health and Human Services commissioned a study to assess the
effectiveness of federal regulations affecting clinical laboratories and their goal of protecting the public health. On
April 8, 1986, the Final Report on Assessment of Clinical Laboratory Regulations by Michael L. Kenney and Don P.
Greenberg was submitted to the ASPE.
The analysis found that many federal regulations are technically obsolescent and many may be
operationally unnecessary as a result of changing laboratory technology and changed federal
reimbursement policies. Among changes recommended by the HHS-funded analysis are: (a) the
regulatory classification system based upon physical location of laboratories is no longer appropriate
117

and should be replaced with a classification system reflecting laboratory functions; (b) a single, uniform
set of federal regulations should be developed that covers all civilian laboratories receMng federal
reimbursement or operating in interstate commerce; (c) a revised federal regulatory system should
emphasize measures of performance such as personnel and inspection requirements; and (c clinical
laboratory regulations should be based upon objective data to the maximum extent possible.
On August 5, 1988, a new set of proposed regulations were put forth by the Health Care Financing Administration as
Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare,
Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs. The proposal aspired "to remove outdated,
obsolete and redundant requirements, make provision for new technologies, place increased reliance on outcome
measures of performance, and emphasize the responsibilities and duties of personnel rather than the formal
credentialing requirements and detailed personnel standards in existing regulations." This ultimately led to the
proposal becoming law on October 31, 1988 under Public Law 100-578 as the Clinical Laboratory Improvement
Amendments of 1988.
Regulations for implementing CLIA continued to be developed afterwards, with the Department of Health and
Human Services considering thousands of comments to the proposed regulations. The final regulations were
published February 28, 1992, set to be effective on September 1 of the same year. The new CLIA '88 put into place
regulations concerning test complexity, certification, proficiency testing, patient test management, personnel
requirements, quality assurance, and other processes in the clinical laboratory. However, phase-in effective dates
were extended on several occasions afterwards: on December 6, 1994 in the Federal Register (59 FR 62606), May
12, 1997 in the Federal Register (62 FR 25855), October 14, 1998 in the Federal Register (63 FR 55031), and
December 29, 2000 in the Federal Register (65 FR 82941).
On January 24, 2003, the Centers for Medicare and Medicaid Services submitted their final rule (68 FR 3639),
effective April 24, 2003, affecting QC requirements for laboratories and qualification requirements for lab directors.
The final rule also made revisions to 42 CFR 493, including the renaming, reorganizing, and consolidation of similar
requirements into one section, the deletion of duplicate requirements, and the rewording of the requirements to better
clarify their original intent. It also addressed requirements regarding the entire testing process, making those
requirement better correlate with the workflow of a lab specimen in the laboratory, from acquisition to reporting of
results, including the subdivision of testing into pre-analytic, analytic, and post-analytic phases.
CLIA program
The CLIA program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical
laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of
providing information for:
diagnosis, prevention, or treatment of disease or impairment.
health assessments.
The CLIA program is designed to ensure the accuracy, reliability, and timeliness of test results regardless of where
the test was performed. Each specific laboratory system, assay, and examination is graded for level of complexity by
assigning scores of "1," "2," or "3" for each of seven criteria. A test scored as a "1" is the lowest level of complexity,
while a test scored "3" indicates the highest level. A score of "2" is assigned when the characteristics for a particular
test are ranked primarily between low- and high-level in description.
The seven criteria for categorization are:
1. Knowledge
2. Training and experience
3. Reagents and materials preparation
4. Characteristics of operational steps
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5. Calibration, quality control, and proficiency testing materials
6. Test system troubleshooting and equipment maintenance
7. Interpretation and judgment
The Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA
program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and
Certification Group, and the Division of Laboratory Services.
The CLIA Program is funded by user fees collected from over 244,000 laboratories, most located in the United
States.
CLIA waived tests

Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate
of waiver. In its 2014 document Administrative Procedures for CLIA Categorization - Guidance for Industry and
Food and Drug Administration Staff, the U.S. Food and Drug Administration (FDA) advises its staff that a medical
testing device originally rated moderately complex could receive a waiver "if the device is simple to use and the
sponsor demonstrates in studies conducted at the intended use sites that the test is accurate and poses an insignificant
risk of erroneous results."
While a waived test is deemed to have an acceptably low level of risk, the Centers for Disease Control and
Prevention (CDC) reminds administrators and recipients of such tests that no test is 100 percent safe:
Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this
does not mean that waived tests are completely error-proof. Errors can occur anywhere in the testing
process, particularly when the manufacturer's instructions are not followed and when testing personnel
are not familiar with all aspects of the test system. Some waived tests have potential for serious health
impacts if performed incorrectly... To decrease the risk of erroneous results, the test needs to be
performed correctly, by trained personnel and in an environment where good laboratory practices are
followed.
In November 2007, the CLIA waiver provisions were revised by the United States Congress to make it clear that
tests approved by the FDA for home use automatically qualify for CLIA waiver.
List of tests
A list of tests categorized by the FDA as waived since 2000 can be found at the FDA website [1]. As of February 17,
2015, the list included 6,669 separate test devices.
Further reading
Kenney, Michael L. (February 1987). "Quality Assurance in Changing Times: Proposals for Reform and Research
in the Clinical Laboratory Field" [2] (PDF). Clinical Chemistry 33 (2): 328336. PMID [3]3542302 [4].
External links
42 CFR 493 at the U.S. Government Printing Office [5]
CLIA Law & Regulations at CDC [6]
Chronology of CLIA Related Documents in the Federal Register & Code of Federal Regulations [7]
119
Notes
A couple elements of this article are reused from the Wikipedia article [8].
References
[1]
[2]
[3]
[4]
[5]
[6]
[7]
[8]
http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfClia/ testswaived. cfm
http:/ / www. clinchem. org/ content/ 33/ 2/ 328. full. pdf
http:/ / en. wikipedia. org/ wiki/ PubMed_Identifier
http:/ / www. ncbi. nlm. nih. gov/ pubmed/ 3542302
http:/ / www. gpo. gov/ fdsys/ granule/ CFR-2011-title42-vol5/ CFR-2011-title42-vol5-part493/ content-detail. html
http:/ / wwwn. cdc. gov/ clia/ Regulatory/ default. aspx
http:/ / wwwn. cdc. gov/ CLIA/ Regulatory/ Chronology. aspx
http:/ / en. wikipedia. org/ wiki/ Clinical_Laboratory_Improvement_Amendments
Health Level 7
Health Level Seven (HL7) is an
international
non-profit
volunteer-based organization involved
with the development of international
health care informatics interoperability
standards. The HL7 community
consists of health care experts and
information scientists collaborating to
create standards for the exchange,
management, and integration of
electronic health care information.
The term "HL7" is also used to refer to
some of the specific standards created
by the organization (e.g., HL7 v2.x,
v3.0, HL7 RIM). HL7 and its members
The Reference Information Model (RIM) is an important component of the HL7 v3.0
provide a framework (and related
standard and is based on XML.
standards)
for
the
exchange,
integration, sharing, and retrieval of electronic health information. v2.x of the standards, which support clinical
practice and the management, delivery, and evaluation of health services, are the most commonly used in the world.
History
The International Organization for Standardization (ISO) got involved with standardizing network exchanges of data
between computers around 1979, creating the Open Systems Interconnect (OSI) standards model. These formal OSI
standards ranged across seven levels, from OSI Level 1 (physical layer, e.g. communication over coaxial cable) to
OSI Level 7 (application layer, e.g. communication between clinical software). By 1981, researchers at University of
California - San Francisco had created a proprietary protocol that unbeknownst to them at the time fit under the OSI
Level 7 model. The protocol was developed for clinical purposes such that "computers exchanged several core
messages, including the synchronization of patient admission-discharge-transfer information, orders from clinical
areas, and the display of textual results to the clinical areas."
By 1985, Simborg Systems (which developed hospital information systems) sought to have a non-proprietary
protocol created because "standardization efforts at the time was either fragmented, in a different direction or with a
120
Health Level 7
different scope." This led to a push to create a new standards organization, with initial meetings occurring at the end
of March 1987. The meetings produced the term "HL7" and prompted a non-profit organization to be created,
eventually known as Health Level Seven International. Version 1.0 of the HL7 specification was released in October
1987. The direction of HL7 was largely led by Simborg Systems; however, with greater practical use seen in
furthering the protocol and non-profit, the first non-Simborg Systems chairperson, Ed Hammond, took the reigns in
1989. By June 1990, Version 2.1 was published and included mechanisms for results reporting and billing. By the
early- to mid-1990s news of HL7 was beginning to spread to international clinical sectors, particularly parts of
Europe, including Netherlands, Germany, Canada, Japan, Australia, and the United Kingdom.
In June 1994 the American National Standards Institute (ANSI) awarded Health Level 7 International status as an
accredited standards developer. Version 2.2 became an official ANSI standard in February 1996. HL7 had roughly
1,700 members from various health care industries around the globe by the late 1990s.
Version 3.0 of the HL7 standard was released in late 2005, which internationalized it and made it more consistent
and precise. Where the 2.x standards eventually received wide adoption for their flexibility and available
implementation options, the 3.0 standards, in contrast, departed from that flexibility in order to be more "definite and
testable, and provide the ability to certify vendors' conformance." In 2009, Corepoint Health reported that most HL7
messaging was occurring using 2.3 and 2.3.1 models, with 3.0-based messages representing only a tiny fraction of all
interfaces; in 2012 Corepoint Health's Rob Brull estimated that more than 90 percent of all healthcare systems were
still utilizing 2.x models. That trend continued, with several experts proclaiming the standard to be more or less a
failure.
In early 2012, HL7 announced the HL7 FHIR (Fast Healthcare Interoperability Resources) initiative, which would
utilize the best aspects of both 2.x and 3.0 standards, optimally resulting in a standard that is 20 percent the size of
3.0 but still meet the operation requirements of 80 percent of systems using the standard. FHIR is being built on
RESTful web services and provides modular, extensible "resources" to provide some flexibility but within a more
fixed framework. In December 2014, HL7 announced the Argonaut Project, meant "to hasten current FHIR
development efforts in order to create practical and focused guidelines and profiles for FHIR by the spring of 2015."
Standards
In total HL7 develops conceptual standards (e.g., HL7 RIM), document standards (e.g., HL7 CDA), application
standards (e.g., HL7 CCOW), and messaging standards (e.g., HL7 v2.x and v3.0). Messaging standards are
particularly important because they define how information is packaged and communicated from one party to
another. Such standards set the language, structure, and data types required for seamless integration from one system
to another. Business use of the HL7 standards requires a paid organizational membership in HL7, Inc. HL7 members
can access standards for free, and non-members can buy the standards from HL7 or ANSI.
HL7 v2.x and 3.0 are the primary standards from the organization. They provide a framework for data exchange
among clinical and healthcare systems in an ideal format. The 2.x standards are flexible, with several implementation
options, loosely geared towards "clinical interface specialists" working to move clinical data in the application space.
The 3.0 standards are designed to be more fixed, precise, and international, geared towards governments and end
users of clinical applications.
While HL7 v2.x and 3.0 are the primary standards, a few other important standards and components are associated
with HL7, as detailed below.
121
Health Level 7
Reference Information Model (RIM)

The Reference Information Model (RIM) is an important component of the HL7 Version 3 standard. RIM expresses
the data content needed in a specific clinical or administrative context and provides an explicit representation of the
semantic and lexical connections that exist between the information carried in the fields of HL7 messages. The
standard is accepted as official by the ISO as ISO/HL7 21731; the original was approved in 2006, with a revised
version appearing in 2014.
Clinical Document Architecture (CDA)

The Clinical Document Architecture (CDA) is an XML-based markup standard intended to specify the encoding,
structure, and semantics of clinical documents for exchange. The standard is accepted as official by the ISO as
ISO/HL7 27932; the most current version comes from 2009.
Clinical Context Object Workgroup (CCOW)

The Clinical Context Object Workgroup (CCOW) family of standards are designed to enable disparate applications
to share user context and patient context in real-time, particularly at the user-interface level. CCOW implementations
typically require a CCOW vault system to manage user security between applications. The primary standard under
CCOW is the Context Management Specifications (CCOW), which "serves as the basis for ensuring secure and
consistent access to patient information from heterogeneous sources." This standard is accepted as official by ANSI
as ANSI/HL7 CMS V1.6.
Fast Healthcare Interoperability Resources (FHIR)

The Fast Healthcare Interoperability Resources (FHIR) standard was announced in 2012 and has been in
development since. FHIR is being built on RESTful web services and provides modular, extensible "resources" to
provide some flexibility but within a more fixed framework. The fundamental principles of FHIR are:
prioritize implementers as the target user of the standard;

provide a flexible framework for interoperability;
limit complexity to where it's most needed;
keep conformance requirement minimal but also provide varying degrees of rigor;
leverage open source development principles;
make the standard available without cost;
support multiple exchange architectures;
leverage common web technologies;
make the standard forward and backward compatible; and
design, publish, and implement associated specifications using widely available tools.
122
Health Level 7
123
Further reading
Introduction to HL7 Standards [1]
Spronk, Ren (05 September 2014). "The Early History of Health Level 7" [2]. Ringholm BV.
External links
Health Level 7 International [3]
HL7 Wiki [4]
HL7 FHIR [5]
References
[1]
[2]
[3]
[4]
[5]
http:/ / www. hl7. org/ implement/ standards/ index. cfm

http:/ / www. ringholm. com/ docs/ the_early_history_of_health_level_7_HL7. htm
http:/ / www. hl7. org/
http:/ / wiki. hl7. org/ index. php?title=Main_Page
http:/ / wiki. hl7. org/ index. php?title=FHIR
ISO 9000
ISO 9000 is a family of standards
related to quality management systems
and designed to help organizations
ensure that they meet the needs of
customers and other stakeholders. The
standards are published by the
International
Organization
for
Standardization
(ISO)
and
are
available through national standards
bodies. ISO 9000 deals with the
fundamentals of quality management
systems , including the eight
management principles on which the
family of standards is based.
A General Motors assembly plant advertises its ISO 9001 certification.
ISO 9001 deals with the requirements

that organizations wishing to meet the standard have to fulfill. Third party certification bodies provide independent
confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwide are
independently certified, making ISO 9001 one of the most widely used management tools in the world today.
Despite widespread use, however, the ISO certification process has been criticized as being wasteful and not being
useful for all organizations.
ISO 9000
History
The ISO 9000 family of standards was originally built on several British standards developed in the early 1970s: BS
9000, BS 5179, and BS 5750. These quality assurance standards were initially related to the electronics
manufacturing industry and set guidelines on managing supply-side quality through auditing and contractual
documentation. However, the history of ISO 9000 can be traced back even further to the publication of the United
States Department of Defense MIL-Q-9858 standard in 1959. MIL-Q-9858 was revised into the NATO AQAP series
of standards in 1969, which in turn were revised into the BS 5179 series of guidance standards published in 1974,
and finally revised into the BS 5750 series of requirements standards in 1979.
As the idea of company certification of meeting a certain level of quality became more attractive, the push for a more
rigorous international standard (primarily led by the British Standards Institute [BSI]) resulted in the creation of the
ISO 9000 family in 1987. Originally based on BS 5750, the ISO 9000 family started out with three quality
management models and a set of guidelines for following them:
ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing
ISO 9002:1987 Model for quality assurance in production, installation, and servicing
ISO 9003:1987 Model for quality assurance in final inspection and test
ISO 9004.1:1987 Quality management and quality system elements - Part 1: Guidelines
Changes to ISO 9000

In 1994, the ISO 9000 standards were updated to place focus on the importance of quality control and preventative
action, and emphasize the need for the documentation of procedures.
In 2000, ISO 9001, 9002, and 9003 were combined into ISO 9001:2000, with a major shift in focus towards quality
management versus quality control as well as a focus on process management, "the monitoring and optimizing of a
company's tasks and activities, instead of just inspecting the final product." It directed manufacturers to carefully
examine client requirements in order to design and improve processes and improve customer satisfaction.
The 2008 changes to ISO 9001 were minimal, clarifying and simplifying language while making it more consistent
with other standards.
The ISO 9004 guidelines document was updated in 2009 "to promote a sustainable business approach" that focused
on all stakeholders.
An updated version of ISO 9001 is expected at the end of 2015 if the ISO members vote favorably in the second
quarter of 2015. With the revision the scope of the standard will not change. An essential change, however, will
affect the structure. The new ISO 9001:2015 will follow the so-called high-level structure. This, and the uniform use
of core texts and terms, will enable an identical structure for all management systems.
Adoption of the standard

The global adoption of ISO 9001 may be attributable to a number of factors. Many major purchasers require their
suppliers to hold ISO 9001 certification. In addition to several stakeholders' benefits, a number of studies have
identified significant financial benefits for organizations certified to ISO 9001. Examples include:
1. In 2002, Heras et al. found superior return on assets compared to otherwise similar organizations without
certification and demonstrated that this was statistically significant and not a function of organization size.
2. A 2003 study of 146 Singapore-based companies by Chow-Chua et al. found improved financial performance,
though with the caveat "that while certification leads to better overall financial performance, nonlisted certified
firms experience better documentation procedures, higher perceived quality of products or services, and more
effective communication among employees than listed certified firms."
124
ISO 9000
3. That same year Rajan and Tamimi showed that ISO 9001 certification resulted in superior stock market
performance and suggested that shareholders were richly rewarded for investing in the certified companies.
4. In 2005, Corbett et al. showed in 2005 similar superior performance, atating that "three years after certification,
the certified firms do display strongly significant abnormal performance under all control-group specifications."
5. That same year, Sharma linked increases in "operating efficiency, growth in sales, and overall financial
performance" gains with ISO 9000 certification.
6. Naveha and Marcus claimed in 2007 that manufacturers in the U.S. automotive industry that implemented ISO
9001 saw superior operational performance soon after.
7. A 2011 survey from The British Assessment Bureau showing 44 percent of their certified clients had won new
business due to becoming certified.
While the connection between superior financial performance and ISO 9001 may be seen from the examples cited,
there remains no proof of direct causation, though longitudinal studies such as those of Corbett et al. may suggest it.
Other researchers such as Heras et al. have suggested that while there is some evidence of this, the improvement is
partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.
Criticisms of the standard

A common criticism of the ISO 9000 family of standards is the amount of money, time, and paperwork required for
registration. In 2003, writing for Quality Magazine, engineer Scott Dalgleish emphasized that "[u]nder ISO, every
quality system enhancement triggers enormous documentation changes that make quality managers question whether
the benefits of the change are worth the effort." In a piece for Inc. magazine in 2005, journalist Stephanie Clifford
told the story of Delaware North Companies, which spent nearly 18 months and $115,000 just to certify their guest
services management division.
Others have chosen not to adopt the standard because of the perceived risks and uncertainty of not knowing if there
are direct relationships to improved quality as well as doubts about what kind and how many resources will be
needed. Other perceived risks include how much certification will cost, increased bureaucratic processes, and risk of
poor company image if the certification process fails. Critics like John Seddon, a leading global authority on the
service industry, claim ISO 9001 promotes specification, control, and procedures rather than understanding and
improvement. Others like business improvement specialist Jim Wade have argued that ISO 9001 is effective as a
guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means
better quality, ... [undermining] the need for an organization to set its own quality standards." In short, Wade argues
that reliance on the specifications of ISO 9001 does not guarantee a successful quality system.
The standard has been seen as especially prone to failure when a company is interested in certification before quality.
Certifications have in fact often been based on customer contractual requirements rather than a desire to actually
improve quality. "If you just want the certificate on the wall, chances are you will create a paper system that doesn't
have much to do with the way you actually run your business," said ISO's Roger Frost in 2001. Certification by an
independent auditor is often seen as the problem area, and according to Barnes, it "has become a vehicle to increase
consulting services."
125
ISO 9000
126
Further reading
Cochran, Craig (2008). ISO 9001 in Plain English [1]. Paton Professional. pp.178. ISBN [2]9781932828207.
External links
ISO 9000 [2] at the International Organization for Standardization
Notes
This article reuses a few elements from the Wikipedia article [3].
References
[1] https:/ / books. google. com/ books?id=-GplCM5xTYYC
[2] http:/ / www. iso. org/ iso/ iso_9000
[3] http:/ / en. wikipedia. org/ wiki/ ISO_9000
ISO/IEC 17025
ISO/IEC 17025 is an International
Organization for Standardization (ISO)
standard used by testing and
calibration laboratories to provide a
basis for accreditation of laboratory
quality systems. There are many
commonalities with the ISO 9000
family of standards, but ISO/IEC
17025 adds in the concept of
competence to the equation, applying
directly to those organizations that
produce testing and calibration results.
History
Even military testing and calibration labs like the Navy Standards Laboratory (WPP) opt
to get ISO/IEC 17025 certified.
ISO/IEC 17025 was originally known as ISO/IEC Guide 25, first released in 1978, with subsequent editions
following in 1982 and 1990. Guide 25 was created with the belief that "third party certification systems [for
laboratories] should, to the extent possible, be based on internationally agreed standards and procedures." In the midto late 1990s, an update to Guide 25 was required. However, the ISO decided to convert the guide into a standard
and introduce tight compatibility with ISO 9001, which was also being revised, such that ISO 9001 would be treated
as a master standard and the next evolution of Guide 25 to be treated as a standard to be specifically applied to
testing and calibration laboratories.
ISO/IEC 17025:1999 was issued by the ISO in late 1999 and was internationally adopted in 2000. A second release
was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000
version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior
management, as well as explicit requirements for continual improvement of the management system itself,
particularly communication with the customer.
ISO/IEC 17025:1999 became defunct in May 2007.
ISO/IEC 17025
The standard
The ISO/IEC 17025 standard itself comprises five elements: scope, normative references, terms and definitions,
management requirements, and technical requirements. Two annexes are also included. In particular the management
and technical requirements are the most important sections, with the management requirement section detailing the
operation and effectiveness of the quality management system within the laboratory and the technical requirements
section detailing the factors which determine the correctness and reliability of the tests and calibrations performed in
laboratory.
The standard is organized as follows:
Scope
The scope of the standard is described over six points. It states what type of testing and calibration is covered; who
it's applicable to; the purpose for the standard; what's not covered; and how it relates to ISO 9001.
Normative references
This section states both ISO/IEC 17000 and the International Vocabulary of Metrology (VIM) are vital to applying
the standard.
Terms and definitions

This sections simply states that relevant terms found in the standard can be defined via ISO/IEC 17000 and VIM.
Management requirements
The requirements for the operational effectiveness of a laboratory's quality management system are outlined in this
section. The requirements are broken down into 15 subsections:
4.1 Organization
4.2 Management system
4.3 Document control
4.4 Review of requests, tenders and contracts
4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the customer
4.8 Complaints
4.9 Control of nonconforming testing and/or calibration work
4.10 Improvement
4.11 Corrective action
4.12 Preventive action
4.13 Control of records
4.14 Internal audits
4.15 Management reviews
127
ISO/IEC 17025
Technical requirements
The requirements for staff competence, methodologies, equipment testing and calibration, and test methods are
outlined in this section. The requirements are broken down into 10 subsections:
5.1 General
5.2 Personnel
5.3 Accommodation and environmental conditions
5.4 Test and calibration methods and method validation
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 Handling of test and calibration items
5.9 Assuring the quality of the test and calibration results
5.10 Reporting the results
Annexes
Two annexes and a bibliography are included. Annex A: Nominal cross-references to ISO 9001:2000 provides links
between this standard and ISO 9001, important as this standard includes requirements not covered in ISO 9001.
Annex B: Guidelines for establishing applications for specific fields gives accreditation seekers explanations of
specific requirements to better complete their applications.
Accreditation
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently
produce valid results. It is also the basis for accreditation from an accreditation body. Since the standard is about
competence, accreditation is simply formal recognition of a demonstration of that competence. A prerequisite for a
laboratory to become accredited is to have a documented quality management system. The usual contents of the
quality manual follow the outline of the ISO/IEC 17025 standard.
National accreditation bodies are primarily responsible for accrediting laboratories to ISO/IEC 17025. Laboratories
can use either a domestic organization or some other internationally recognized body in cases where the domestic
organization "has either no international recognition or where it lacks recognition in parts of the world relevant to the
laboratorys operations." Laboratories typically select a range of common and frequently used methodologies that
could readily benefit and demonstrate a comprehensive quality system that those methodologies run under.
128
ISO/IEC 17025
129
Further reading
"Complying with ISO 17025" [1] (PDF). United Nations Industrial Development Organization. October 2009. pp.
106.
External links
ISO 17025:2005 [2]
ISO 17025:2005 [3] on the ISO Online Browsing Platform
References
[1] http:/ / www. unido. org/ fileadmin/ user_media/ Publications/ Pub_fr/ Complying_with_ISO_17025_A_practical_guidebook. pdf
[2] http:/ / www. iso. org/ iso/ catalogue_detail. htm?csnumber=39883
[3] https:/ / www. iso. org/ obp/ ui/ #iso:std:iso-iec:17025:ed-2:v1:en
ISO/TS 16949
ISO/TS 16949 is an International
Organization for Standardization (ISO)
technical
specification
for
the
development of a quality management
system,
specifically
for
the
development, production, and, when
relevant, installation and servicing of
automotive-related
products.
The
standard provides for continual
improvement of these processes,
emphasizing defect prevention and the
reduction of variation and waste in the
supply chain. It is based on the ISO
9001 standard.
Manufacturers of automotive parts supplied to automakers most certainly must get

ISO/TS 16949 certified to remain competitive.
History
ISO/TC 16949 is based on DaimlerChrysler, Ford, and General Motors' QS-9000 quality systems standards as well
as the ISO 9000 family of standards. In June 1988, at the ASQ Automotive Division conference, a group of parts
suppliers suggested to the attending vice presidents the need for a set of quality assessment standards separate from
the ISO 9000 standards, which were introduced only a year earlier. At that time suppliers noted that ISO 9000
"lacked some elements in current automotive industry documents, such as business plans, customer satisfaction,
continuous improvement, manufacturing capabilities, and much of the advanced quality planning content." The
QS-9000 manual based on content from ISO 9001 was eventually released in August 1994, followed by a
second edition in February 1995, which caught on worldwide with other original equipment manufacturers (OEMs).
A few months later, at a European QS-9000 implementation meeting, representatives for the U.S. automakers
learned that similar efforts had already been underway in the forms of "VDA 6.1 in Germany, AVSQ in Italy, and
EAQF in France." A desire to further unify these disparate standards was expressed, resulting in the creation of the
International Automotive Task Force (IATF).
ISO/TS 16949
The ISO Technical Committee (TC) 176, responsible for quality management and assurance standards, took notice
and, not wanting to fraction ISO 9000 standards into sector-specific branches, attempted to convince the IATF to
adopt ISO 9000. However, after several meetings, the TC 176 agreed the family of standards was not comprehensive
enough for the automotive industry and vowed to include updates in the next version. Though the technical
committee worked with the IATF, their needs were different enough that the automotive-specific changes would not
be able to make it into the upcoming 2000 iteration. By November 1997, the two groups agreed on using the ISO
technical report as a tool for the requirements, which would be based off of ISO 9001:1994.
By the time the first draft document was created in the fall of 1998, a new type of ISO document became available: a
Technical Specification (TS). The IATF agreed to this format, and in November 1998, ISO/TS 16949 was initially
approved as the first ISO Technical Specification, with a second official printing arriving in March 1999. In March
2002, a revised ISO/TS 16949:2002 was released to align with changes to ISO 9001, putting more focus on how "to
improve effectiveness and efficiency of the entire process instead of a narrow focus on mere compliance with
standards." The current version is ISO/TS 16949:2009. It was released in July 2009 and draws off of ISO 9001:2008,
"emphasizing defect prevention and the reduction of variation and waste in the supply chain."
The standard
ISO/TS 16949 applies to the design, development, production and, when relevant, installation and servicing of
automotive-related products. The requirements are intended to be applied throughout the supply chain, with vehicle
assembly plants being encouraged to seek ISO/TS 16949 certification so as to improve system and process quality,
to increase customer satisfaction, to identify problems and risks in production process and supply chain, and to take
preventive measures to ensure effectiveness.
The technical specification is organized as follows:
Introduction
This section introduces the perceived importance of quality management systems as well as adopting a process-based
approach to their development and implementation. It also addresses its relationship to the ISO 9001, 9004 and
14001 standards.
Scope
The scope and application of the standard is described as defining "the quality management system requirements for
the design and development, production and, when relevant, installation and service of automotive-related products."
Normative references
This section states the definitions in ISO 9000:2005 are vital to applying the specification.
Terms and definitions

Additional definitions like "control plan," "error proofing," and "laboratory scope" are defined.
Quality management system

The requirements for the operational effectiveness of a manufacturer's quality management system are outlined in
this section. The requirements are broken down into two subsections:
4.1 General requirements
4.2 Documentation requirements
130
ISO/TS 16949
Management responsibility
This section outlines the managerial responsibilities associated with designing and implementing a quality
management system. These responsibilities are broken into six subsections:
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review
Resource management
This section outlines the requirements for managing the various resources needed to develop and maintain a quality
management system as well as improve its effectiveness. These responsibilities are broken into four subsections:
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
Product realization
The requirements for managing the aspects of a quality management system that directly affects how products are
designed, produced, and shipped are covered in this section, which spans six subsections:
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring equipment
Measurement, analysis and improvement

The requirements of this section address how products created through the quality management system should
conform and be continually assessed for improvement. This section is divided into five subsections:
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
131
ISO/TS 16949
Annex A
Annex A: Control plan "shows the correspondence between ISO 9001:2008 and ISO 14001:2004."
Certification
Manufacturers get ISO/TS 16949 certified based of the certification rules issued by the International Automotive
Task Force (IATF). Those certification rules changed in April 2014, "intended to strengthen the value of the
certification as seen by the customers of the scheme, i.e. the automotive OEMs who receive the products that are
produced by the suppliers certified to the scheme." The new rules place extra emphasis on customer-measured
performance as well as audit planning, including additional controls on site extensions, ring fencing, and
nonconformity management. In March 2014, standards institute BSI outlined all the changes that took place to the
certification process in their document Presentation by BSI on the main changes to the IATF ISO/TS 16949
certification scheme.
Certifications last three years, and according to the new rules, the first recertification audit should be completed
within exactly three years of the initial Stage 2 audit.
Further reading
Lomas, Frank (14 March 2014). "Presentation by BSI on the main changes to the IATF ISO/TS 16949
certification scheme" [1] (PDF). The British Standards Institution.
External links
ISO/TS 16949 standards at the International Organization for Standardization [2]
References
[1] http:/ / www. bsigroup. com/ LocalFiles/ en-US/ Documents/ TS16949changespresentations. pdf
[2] http:/ / www. iso. org/ iso/ catalogue_detail?csnumber=52844
132
The American Society of Crime Laboratory

Directors/Laboratory Accreditation Board
The American Society of Crime
Laboratory
Directors/Laboratory
Accreditation Board (ASCLD/LAB)
is a Missouri-based not-for-profit that
"offers voluntary accreditation to
public and private crime laboratories"
around the world. Laboratories wishing
to become accredited must go through
a proficiency testing program as part of
the accreditation process.
The
main
objectives
ASCLD/LAB are:
of
the
1. To improve the quality of

More than 400 crime labs around the world have chosen to get accredited by the
laboratory services provided to the
ASCLD/LAB.
criminal justice system.
2. To adopt, develop and maintain
criteria which may be used by a laboratory to assess its level of performance and to strengthen its operation.
3. To provide an independent, impartial, and objective system by which laboratories can benefit from a total
operational review.
4. To offer to the general public and to users of laboratory services a means of identifying those laboratories which
have demonstrated that they meet established standards.
History
The American Society of Crime Laboratory Directors (ASCLD) was officially founded in the fall of 1974. Around
the same time, a national examination of forensic science laboratories began, culminating in 1977 with the revelation
that many mistakes were being made in those labs. The problematic statistics that came out of that research partially
drove the ASCLD to create the Laboratory Accreditation Board (LAB) in the summer of 1981. The ASCLD/LAB
eventually incorporated as a non-profit corporation in Missouri on February 4, 1988. By June 1992, the organization
had accredited 128 laboratories, including its first international laboratory, located in Adelaide, Australia. By the
spring of 2014 that total was 403.
Accreditation
ASCLD/LAB accredits forensic laboratories and certain forensic breath alcohol calibration programs to help them
"demonstrate that its technical operations and overall management system meet ISO/IEC 17025:2005 requirements
and applicable ASCLD/LAB-International supplemental requirements." Application review, on-site assessments,
quality review, and, if necessary, corrective action resolutions are conducted before the final review and
accreditation decision. The International accreditation typically is good for four years as long as the lab remains
compliant and maintains obligations such as notification of significant changes to primary policies, resources,
organization, and legal ownership.
133
Compliance
After acceptance, ASCLD/LAB uses its Annual Accreditation Audit Report, proficiency testing reports, and
laboratory visits to monitor a crime lab's compliance with the body's accreditation standards. In the unusual case of a
laboratory failing to comply with those standards, the ASCLD may choose to place the lab on probation. Examples
of such probationary action include the Nassau County, New York crime lab in 2007 and 2010 and the El Paso
Police Department in 2011. Once on probation, the affected lab must satisfy certain conditions before being able to
again operate and eventually be removed from the probationary period, including but not limited to submitting lab
analyses for external technical reviews. In extreme cases of non-compliance, the ASCLD can also choose to suspend
the lab for a period of time or even revoke the lab's accreditation.
External links
ASCLD [1]
ASCLD/LAB [2]
References
[1] http:/ / www. ascld. org/
[2] http:/ / www. ascld-lab. org/
The NELAC Institute

The NELAC Institute (TNI) is a non-profit organization dedicated to promoting "the generation of environmental
data of known and documented quality through an open, inclusive, and transparent process that is responsive to the
needs of the community." The founders' long-term motivation behind the creation of the NIC was to enact a
"uniform, rigorous, and robust" nationwide environmental laboratory and monitoring accreditation program. This
accreditation program exists today in the form of the National Environmental Laboratory Accreditation Program
(NELAP).
History
The NELAC Institute (TNI) was formed on November 6, 2006 as a collaboration between the National
Environmental Laboratory Accreditation Conference (NELAC) and the Institute for National Environmental
Laboratory Accreditation (INELA) with "the vision that all entities generating environmental data in the United
States be accredited to a national standard."
With the original 2003 NELAC Standard and 2005 updates to ISO/IEC 17025 as their guide, TNI continued work on
revising the NELAC Standard, culminating in the release of its new standards in July 2011. The revisions both made
ISO/IEC 17025 adherence mandatory and added analysis requirements for "five new contaminants and lower limits
for existing contaminants."
National Environmental Laboratory Accreditation Program

NELAP is an accreditation program targeted at environmental laboratories. The laboratory and accreditation body
standards for the program are modeled after sections of ISO/IEC 17025 and ISO/IEC 17011. Accreditation for
NELAP is performed by U.S. state governmental agencies that wish to participate; control over scope, laboratory
types accepted, and fees are all controlled by the state agency. As of February 2015[1], 14 agencies in 13 states are
organized as NELAP accreditation bodies. Those states are Florida, Illinois, Kansas, Louisiana, Minnesota, New
Hampshire, New Jersey, New York, Oregon, Pennsylvania, Texas, Utah, and Virginia. California used to also
134
The NELAC Institute

participate but withdrew from the program on January 31, 2014.
Environmental laboratories seeking NELAP accreditation are directed to go to their State's accreditation body. If the
lab's state doesn't have such a body, the lab is still able to select an out-of-state body to do the accreditation for them.
This sort of "reciprocal certification" has the disadvantage that the accredited lab will only be certified to test a
certain subset of analytes and contaminants, specifically those chosen for coverage by the state's accreditation body.
This requires labs to carefully select which state agency to go through. Once the application stage begins, labs go
through a series of performance evaluation studies and on-site auditing as well as pay the necessary fees. Each state
may vary its audit requirements for labs maintaining accreditation.
External links
The NELAC Institute [2]
National Environmental Laboratory Accreditation Program [3]
TNI LAMS [4]
References
[1] http:/ / www. limswiki. org/ index. php?title=The_NELAC_Institute& action=edit
[2] http:/ / www. nelac-institute. org/ index. php
[3] http:/ / www. nelac-institute. org/ newnelap. php
[4] http:/ / lams. nelac-institute. org/
135
136
7. Laboratory Informatics Resources

LIMSWiki:LIMSforum and LIMS/LI forum
posts
This page was created to collect most of the commented and active threads from the LIMSforum and LIMS/LI user
groups hosted on LinkedIn. (Threshold is three or more comments.) The LIMSforum's goal is to "connect, share, and
learn about laboratory, scientific, and healthcare informatics," while LIMS/LI is more focused on laboratory
informatics.
Note: This page is updated once a month, typically at the beginning of the month. We run two months behind current
to allow posts to accumulate comments first.
Commented and Active Posts from LIMSforum and LIMS/LI
Post
#
Title
711.
Suggestions for simple sample-tracking software?
710.
Author
[1]
Forum
Year Month
Comments Likes
Paul-Michael
Agapow
2015 01
37
New site for LIMSforum.com. Can I get you test the group discussion
[2]
functionality?
John Jones
2015 01
33
709.
When looking for a LIMS professional, should you choose a LIMS

[3]
Consulting firm or a LIMS Staffing firm? What's the difference?
John Jones
2015 01
21
708.
Which makes up the largest share of a LIMS solution: Labor or Software? John Jones
[4]
2015 01
21
707.
LIMS Implementation: "Big Bang" or "Phased Approach"
Howard Rosenberg
2015 01
16
10
706.
Hello, Which are the top 5 vendors for instrument integration for 21 CFR
Part 11 compliant Laboratories. Looking for vendors for instrument
[6]
integration to existing LIMS system.
Mithun Kale
2015 01
14
705.
Looking for lower cost (<200K) LIMS to integrate bio-banking, reagent

inventory, resource scheduling, molecular (nucleic acid isolation, PCR,
[7]
microarray, NGS, esoteric) workflow, and reporting. Ideas?
Deepa Eveleigh
2015 01
12
704.
Happy New Year to all. I am looking for global suppliers who can
provide all LIMS, eLN, SDMS and CDS software and services. Thank
[8]
you.
Amit Rathore
2015 01
10
703.
Who could be the better partner for lab informatics- a vendor with
multiple portfolio in lab including equipment, services etc. such as
[9]
Agilent or a pure player such as LabAnswer?
Amit Rathore
2015 01
702.
What are some Must have features for an LIMS/LIS?
Aneel Irfan
2015 01
701.
For those of you who do LIMS development work, what have you seen as John Jones
[11]
good tools for customizing the LIMS you work with?
2015 01
[10]
[5]
137
700.
Hi. Can anyone guide how to do KPI or quality indicator for medical lab?
[12]
Thanks in advance.
Krija Chennimalai
2015 01
699.
Former Audiology Doctoral student/ current hearing instrument specialist

[13]
seeking to transition into HIM
Sara Chamma
2015 01
698.
Which web browser do you recommend for validated environments?

[14]
Chrome is a non-starter
John Jones
2014 12
45
697.
Would any ELN experts in the group like to collaborate with me on

[15]
creating an ELN / LES combo using BonitaSoft?
John Jones
2014 12
22
696.
How much does a LIMS Cost?
Howard Rosenberg
2014 12
19
695.
Lab Instrument Interface software needed for Veterinary Practice

[17]
Management Software (PMS)
David Wolz
2014 12
18
694.
Does anyone have an experience with open-source LIMS? Can this kind
of LIMS be used instead of the paid LIMS with the same level of
[18]
functionality?
Kasin Toleb
2014 12
18
693.
What are some of the Regulatory / Standards that apply to Agricultural

[19]
Testing labs?
John Jones
2014 12
14
692.
LabWare ELN: any user that could give me his/her opinion? Thank you!
[20]
Pierre Chaumat
2014 12
11
691.
Are there any good Tools or Templates for validating software systems
[21]
other than using MS-Word templates?
John Jones
2014 12
690.
What are the best resources for information about agriculture

[22]
laboratories?
Rebecca Fein
2014 12
689.
Does your lab need LIMS Strategic Planning? Consider this...
John Jones
2014 12
688.
Custom development support in various commercial lims?
Prem K.
2014 12
687.
What is the ISO 15189 requirement checklist for LIMS?
Kamal Kant Gupta
2014 11
39
686.
I am looking for a lab information system for a centralized lab of the

[26]
grouped 6 other labs. Please, give me some recommendations!
Trung Pham
2014 11
36
685.
Does anyone in the group use a Cloud hosting provider to host any
[27]
software you use in your lab?
John Jones
2014 11
32
684.
21 CFR part 11, ISO 17025, other regulatory requirements, security &
[28]
you?
Rebecca Fein
2014 11
18
683.
Professional development for the LIMS community?
Rebecca Fein
2014 11
14
682.
Does anyone have any recommendations on a control charting software

[30]
package?
John Jones
2014 11
14
681.
Hi everybody, my name is Liz and I'm currently a Laboratory Application Elizabeth Hansen
Analyst at ABC Laboratories, Inc. We use LabWare LIMS and I thought
[31]
it would be fun to join this group.
2014 11
10
[16]
[23]
[24]
[25]
[29]
138
680.
Evaluation of Open Source LIMS against the ASTM E1578-13 Standard

[32]
John Jones
2014 11
679.
Labkey LIMS demo server setup for use
John Jones
2014 11
678.
Just joined the group, will be looking at the Lims system. BTW, are there
any important groups where I could locate a good organics chemist in the
[34]
Mid-Atlantic area?
Stephen Giannetti
2014 11
677.
Getting smart about antibiotics
Rebecca Fein
2014 11
676.
Atlanta January Event Planning
Rebecca Fein
2014 11
675.
What is typically covered in an Annual Maintenance & Support

[37]
Agreement for a LIMS? Is it worth the cost?
John Jones
2014 10
19
674.
A client of mine considering transformation into new LIMS, Is there any

[38]
LIMS vendor willing to work with an entrepreneur?
Katayoon Bitarafan
2014 10
13
673.
LIMS in the Cloud
Miguel Angel
Laffont
2014 10
12
672.
Instrument Integration via middleware or driver based -- which is more

[40]
effective?
Somnath Mukherjee
2014 10
12
671.
Is it time for a new era in LIMS?
[41]
John Jones
2014 10
670.
Has anyone used Docker as a container for LIMS, or in a lims setting?

[42]
What were your experiences?
Scott Lett
2014 10
669.
Laboratory Information System Management (LIMS)
Daniel Aittie
2014 10
668.
How important is data?
Rebecca Fein
2014 10
667.
Example deployment of LIMS using Docker. Please test it and see what
[45]
you think
John Jones
2014 10
666.
What are the best curation tools for professional librarians?
Knimbus Online Pvt.

Ltd.
2014 10
665.
What do you think is the best way to list Lab Informatics vendors and
products such that it help folks find the most relevant product for their
[47]
needs?
John Jones
2014 10
664.
"The future of LIMS"
Ruth Thompson
2014 09
35
663.
Looking for LIMS vendor recommendations
William Scruggs
2014 09
23
662.
LIMS Service Offerings
Bryn Hird
2014 09
20
661.
Hi all, Is there any cost effective Instrument Integration software

available which can integrate with any LIMS and with any instrument?
[51]
Sachin Pawar
2014 09
20
[33]
[35]
[36]
[39]
[43]
[44]
[46]
[48]
[49]
[50]
139
660.
Damilare Adeoye
Optimistic about this "big data" of a thing, how does it relate to LIMS?
What are the merit and demerit? In general, how does big data relates to a
[52]
Quality Control personnel in the Laboratory?
2014 09
13
659.
FDA approves new Ebola drug
Zubair A.
2014 09
11
14
658.
I thought you all might be interested in this
Rebecca Fein
2014 09
10
657.
Dear LIMS colleagues, Im looking for information about LIMS but

[55]
focused on Gene discovery
Alberto Tafla
2014 09
10
656.
Assistance please. Need help identify who are the largest labs in US by
[56]
market share
Michael Smith
2014 09
655.
As technology matures, are we seeing more fake innovations?
John Jones
2014 09
654.
StarLIMS questions: Looking to learn about installation options
Harry Harlow
2014 09
653.
LIMS and reliability testing
Inge Horrevorst
2014 09
652.
Smart devices in the lab?
Ramon De Groot
2014 09
651.
Umesh Patil
How to compare two different LIMS like LabWare LIMS and
[61]
SampleManager? Which product is best suited for Pharma company?
2014 09
650.
SDMS and Meeting Regulatory Requirements
Shawn Douglas
2014 09
649.
Can you please provide me a list of Laboratory devices that support HL7
[63]
standard(Hematology)
Koshal Gupta
2014 09
648.
LIMS vs LES
Chintan (Chad) Desai
2014 09
647.
Can anyone suggest an example of a good LIMS demo script?
John Jones
2014 08
16
646.
LIMS - scientific information management?
Li Feng
2014 08
16
645.
Can anyone suggest an example of a good LIMS demo script?
John Jones
2014 08
16
644.
CPOE for lab orders. Am I understanding this concept correctly?
John Jones
2014 08
13
643.
Does anyone have any experience with Medical Laboratory Billing or can John Jones
[68]
recommend some possible billing service providers?
2014 08
11
642.
Can anyone suggest some good wiki sites dedicated to bioinformatics,

healthcare informatics and other informatics disciplines? Please post
[69]
links.
John Jones
2014 08
11
641.
LIMS Pricing
Abeer Mushtaq
2014 08
640.
Instrument Interface Company in India
Debasish Mukherjee
2014 08
639.
How do you feel about LIMSForum webinars?
Rebecca Fein
2014 08
[53]
[54]
[57]
[58]
[59]
[60]
[62]
[64]
[65]
[66]
[70]
[71]
[72]
[65]
[67]
140
[73]
638.
Any Lab Informatics Architecture Model out there?
637.
September 22, 2014 HIPAA Business Associate Agreement Deadline IS 3 Owen D. Kurtin
[74]
Weeks Away
636.
Sustainability of the entry of Western LIMS players in Asian markets
635.
Example Wastewater Treatment Plant Laboratory Quality Manual
634.
What is molecular diagnostics, technique or type of laboratory?
633.
I'm curious if there ever can be a truly multi sector LIMS accepted by all
[78]
business users?
632.
Chintan (Chad) Desai
2014 08
2014 08
2014 08
John Jones
2014 08
Rebecca Fein
2014 08
Nigel Mayling
2014 08
John Jones
2014 08
Abeer Mushtaq
2014 08
Rebecca Fein
2014 08
[82]
Reda T. Hojeij
2014 08
[83]
John Jones
2014 08
John Jones
2014 08
Jay Kim
2014 07
18
Coyt Jackson
2014 07
17
Ramon De Groot
2014 07
14
John Jones
2014 07
14
Rebecca Fein
2014 07
13
Ali Taghizadegan
2014 07
10
Rebecca Fein
2014 07
Marcel Prudente
2014 07
Matthew Santos
2014 07
Rahul C.
2014 07
Marvin Gonzales
2014 07
[75] Vimal Singh
[76]
[77]
2014 Edition of the Complete Guide to LIMS & Lab Informatics

[79]
Released
[80]
631.
How much of customer's TCO can be reduced?
630.
MDX and the clinical laboratory work flow
629.
What do you think of this?
628.
LIMS problems in Ireland
627.
Alfresco as an SDMS?
626.
I'm searching for the LIMS recommendation for commercial lab
625.
100% Cloud Based LIMS - Can it Succeed?
624.
Automatic processing of paper request forms
623.
Does anyone make use of Project Management applications within the

[88]
laboratory?
622.
Can LIMS/LIS be used to increase patient engagement?
621.
I am searching for LIMS to include ERP or reverse
620.
Is this a slippery slope?
619.
How to assign an equipment without interface software to LIMS?
618.
Has anyone validated Perkin Elmer's Labworks LIMS to 21 CFR Part 11

[93]
compliance?
617.
Test method/Test Group used by Pharma labs - Any Info?
616.
Do you know any Training Version of LIMS?
[81]
[84]
[85]
[86]
[87]
[89]
[90]
[91]
[95]
[94]
[92]
141
615.
How prevalent is middleware for integration of instruments in clinical

[96]
labs?
John Jones
2014 07
614.
How common is POCT1-A2 for interfacing?
Matt Nielsen
2014 07
613.
Is anyone applying advanced analytics tools to LIMS data?
Clive Higgins
2014 07
612.
What should the role of the laboratory and/or laboratory informatics be in

[99]
fighting antibiotic resistance?
Rebecca Fein
2014 06
26
611.
LIMSwiki Article Compilation - a cool example of wiki to ebook

[100]
functionality
John Jones
2014 06
14
11
610.
I am looking for someone to help my company evaluate various

commercial LIMS products and create an interface with my company's
[101]
internal customer information and billing database
Catherine McCord
2014 06
12
609.
Does it make any sense to integrate lab instruments to the EHR?
John Jones
2014 06
12
608.
Lab Informatics topic
Chintan Desai
2014 06
12
607.
If anyone's interested in a get-together for Toronto-area LIMS forum

[104]
members, please contact me, thanks
Jeremy Eastman
2014 06
606.
Do we have a list of service vendors who supports various LIMS, ELN

[105]
platforms?
Frederic Dedieu
2014 06
605.
LIMS reports for regulatory requirements
Chintan Desai
2014 06
604.
I'm working in a condition monitoring laboratory with a large number of

[107]
data. I want to start LIMS
Md. Yeasir Arafat
2014 06
603.
LIMSforum - 5 years and 61,000 members later
John Jones
2014 06
602.
Have you or planning to use Smartphone in your LAB for your customers Chintan Desai
[109]
and lab managers? What are challenges and business cases?
2014 06
601.
Would you be willing to provide some feedback to our new solution that
[110]
integrates Salesforce.com with LIS and LIMS test data?
Steve Snapp
2014 06
600.
Geopolitical impact on laboratories?
Rebecca Fein
2014 06
599.
What is the percentage of current LIMS users have implemented

[112]
interfacing of instruments?
Agaram
Technologies
2014 06
598.
Luminescence data acquisition: WinGlow replacement
[113]
Frederic Dedieu
2014 06
597.
How to make instrument integration with LIMS easier?
[114]
Amber Shao
2014 05
28
596.
Does anyone use Mirth Connect?
[115]
John Jones
2014 05
14
595.
Future Big Lab Data Ecosystems
[116]
Michael Wang
2014 05
11
[97]
[98]
[102]
[103]
[106]
[108]
[111]
142
594.
Besides Quest and Lab Corp, what are the other top clinical diagnostic
labs in the US? Also, which of these have an international presence as
[117]
well?
Jeff Urbanczyk
2014 05
593.
There is always a need to migrate CDS data across CDS platforms. Is

there any Industry best practice or standard tool to migrate these data
[118]
Somnath Mukherjee
2014 05
592.
Which sample inventory management systems should be evaluated in

[119]
comparison with Freezerworks and caTissue?
Lemoene Smit
2014 05
591.
Would anyone be interested in starting a LIMS subgroup for LIMS and

[120]
LIS professionals in the metro Denver area? Contact me!
David Karns
2014 05
590.
LIMS for a Lipidomics Lab
Manfred Raida
2014 05
589.
For those interested in Raspberry Pi
John Jones
2014 05
John Jones
2014 05
Amber Shao
2014 04
23
[121]
[122]
588.
LIMSforum - Atlanta Chapter created. If you live in Atlanta, please join

[123]
and plan to attend our first meetup
587.
Why is defining a sample id format such a complicated task?
586.
What is the best way to handle date/time stamps on LIMS transactions &
[125]
records?
John Jones
2014 04
23
585.
Would anyone be interested in helping me establish a local LIMSforum

[126]
chapter in Atlanta?
John Jones
2014 04
17
584.
What is a Laboratory Execution System (LES) and what type of operation John Jones
[127]
needs it?
2014 04
583.
Using suitable hardware for LIMS in totally aseptic area?
Ornella Siewe
2014 04
582.
Hitachi 912 : Bidirectional Communication
Kaveh Eshkofti
2014 04
581.
Are you planning to use Smartphone in your LAB for your customers and Rahul C.
[130]
lab managers? Thanks for any thoughts.
and Alternate discussion at
[131]
LIMS LI
2014 04
580.
Looking for a simple, off-the-shelf LIMS software
Chi Truong
2014 04
579.
Its Insanely Easy to Hack Hospital Equipment
Mark Northrup
2014 04
578.
In a nutshell, how does HIPAA/HITECH influence LIMS design and

[134]
functionality?
Lemoene Smit
2014 04
577.
A LIMS and laboratory informatics questionnaire for identifying system

[135]
needs and comparing systems in a "request for information" format
Shawn Douglas
2014 04
576.
For those of you who publish academic research papers, do you think a
[136]
wiki is a suitable venue for publishing your research paper?
John Jones
2014 03
44
575.
HHS Unveils Final Rule To Give Patients Direct Access to Lab Results
[137]
Bob Freeman
2014 03
27
[124]
[128]
[129]
[132]
[133]
143
[138]
574.
Is a "Turnkey" LIMS possible?
John Jones
2014 03
22
573.
Escape sequences in ASTM 1394
Valentin Heinitz
2014 03
17
572.
Open Source & Internet of Things (IoT) - is it the future for instrument
[140]
integration?
John Jones
2014 03
16
571.
In October of 2009 you wrote an article entitled: "Is there such a thing as
an Independent LIMS Consultant? Does it matter?" Has your opinion
[141]
changed substantively? If so how?
Greg Aldrich
2014 03
16
570.
Why HIPAA isnt enough to keep patient data secure
Nadia Gordon
2014 03
14
569.
Feedback for this introductory clinical informatics course, please?
Shawn Douglas
2014 03
13
568.
RFI, RFP, RFQ - What's the difference and which to use and when to
[144]
use?
John Jones
2014 03
11
567.
Skype in the lab?
Rebecca Fein
2014 03
10
566.
Good morning all, Does anyone know what LIMS systems are primarily
used in the EU? I imagine there will be many providers however I am
[146]
looking for the most common if possible. Thank you, Robert
Robert Conway
2014 03
565.
Cellphone screen used for testing...tomorrow's technology today?
Rebecca Fein
2014 03
564.
eLearning is evolving. Are there opportunities to embed eLearning into

[148]
LIMS?
John Jones
2014 03
563.
Do-It-Yourself LIMS sailing on
Lemoene Smit
2014 02
562.
ASTM over tcp-ip
Amene Allal
2014 03
561.
Are Physician Office Labs (POL) becoming more commonplace? Why

[151]
would a physician's office establish a POL?
John Jones
2014 02
46
560.
I'm interested to get the Forum's views on when/where to apply LIMS vs

[152]
an ELN solution?
Huw Evans
2014 02
15
559.
What are the differences between a Physician Office LIS and a Clinical
[153]
Diagnostics LIS for a Reference Lab or Hospital Lab?
John Jones
2014 02
15
558.
What are the organizations/associations that set the standards for

[154]
Laboratory Data Quality?
Rebecca Fein
2014 02
12
557.
What is your biggest issue / problem / concern with modern laboratory

[155]
technologies?
Joe Liscouski
2014 02
12
556.
ASTM 1394 Operator Identification - Where does the information fits

[156]
best?
Valentin Heinitz
2014 02
12
555.
Is a "Turnkey" LIMS possible?
John Jones
2014 02
12
554.
Integration Testing between LIMS, Integrators and Devices
Abhishek Kumar
2014 02
11
[139]
[142]
[143]
[145]
[147]
[149]
[150]
[138]
[157]
144
553.
Is the concept of a DIY (do-it-yourself) LIMS realistic? Is it for you?

[158]
John Jones
2014 02
552.
Interesting trend in User Interfaces. This is bound to affect where LIMS

[159]
and other lab informatics applications move to in terms of UI
John Jones
2014 02
551.
Trying to find out if LabVantage LIMS 2.0N will operate in Windows 7

[160]
Christine Goreczny
2014 02
550.
We're collecting and creating open science, lab, and informatics courses.
[161]
Your feedback, please?
Shawn Douglas
2014 02
549.
Integrating LIMS with external systems such as CRM, Accounting, etc

[162]
Katharine Kaye
2014 02
548.
Would like feedback on an idea of how to objectively compare LIMS and

[163]
other LI systems
John Jones
2014 02
547.
Announcement from LIMS/Laboratory Informatics - New Owner - Feb

[164]
14, 2014
Terry Iorns
2014 02
546.
It is pure waste to perform labor-intensive hunting for information across

multi-vendor, multi-technique databases. What needs to be done to
[165]
change?
Peter Boogaard
2014 02
545.
Does anyone in the group use the Bika Open Source LIMS? Can you
[166]
provide some feedback?
John Jones
2014 01
54
544.
Jeffrey Lee
I am looking for some LIMS users to help review and test the new
[167]
LIMSpec (LIMS, LIS, ELN user requirements specification) system
2014 01
45
543.
List of SOPs for LIMS and Lab Informatics
Chintan Desai
2014 01
23
542.
LIMS developers: if you've been using VB6, to what will you migrate?
[169]
Katharine Kaye
2014 01
17
541.
Open Source Software Hits a Strategic Tipping Point. I wish that were the John Jones
[170]
case for laboratory instrumentation interfaces.
2014 01
15
540.
Searching for a LIMS software company that can develop a client web
portal with our existing LIMS that is based on MS Access 2007 and an
[171]
Oracle Forms server that runs Labvantage Seedpack
Tim VanWyngarden
2014 01
13
539.
Wearable devices in lab?
Alex Huang
2014 01
11
538.
On-Campus vs. Distance Learning. I would like to get some feedback

[173]
from others as to what works for them
John Jones
2014 01
11
537.
Validating on the Cloud
Alex Birch
2014 01
10
536.
Should specific vendor products not be identified in discussions?
Terry Iorns
2014 01
10
535.
Big Data and the laboratory?
Rebecca Fein
2014 01
534.
LIS adoptions help with more personalized care
Rebecca Fein
2014 01
533.
LIMS software standardization and harmonization references and

[178]
guidelines needed urgently
Ibrahim Al-Bathi
2014 01
[168]
[172]
[174]
[176]
[177]
[175]
145
532.
Would a set of free, customizable SOP templates be of use to your lab

[179]
with respect to LIMS & LIS operations?
John Jones
2014 01
531.
Announcement from LIMS/Laboratory Informatics - January 9, 2014

[180]
Terry Iorns
2014 01
530.
The Aspen Project - New educational project for lab automation /

[181]
informatics
Joe Liscouski
2014 01
529.
LIMS industry report(s)
Pradeep Saini
2014 01
528.
Large Labs: How do you integrate point of care instrumentation with

[183]
central LIS? What is your integration architecture?
Raechel Wright
2014 01
527.
The Internet of Things (IoT) and the application to instrument interfacing

[184]
and control
John Jones
2014 01
526.
Java Primary Cause of 91 Percent of Attacks: Cisco Reports. With

[185]
HIPAA penalties, avoid use of Java based apps
John Jones
2014 01
525.
Hello and Happy New Year! As I ever attempt to increases my IT skills,

I'm interested in becoming more fluent with LIM concepts and program
[186]
design.
Michael Rule
2014 01
524.
Importance of Data Integrity
Terry Iorns
2014 01
523.
Best of breed sample storage and COC?
Lemoene Smit
2014 01
522.
Benefits of a high quality and highly configured LIMS system
Nicholas Messinese
2014 01
521.
LIMS are enabling the Mobile Lab of the Future
Rahul C.
2014 01
520.
What should the LIMS/LI Motto be?
Alex Birch
2014 01
519.
What software solutions are there for the Physician's Office Lab (POL)?
[192]
John Jones
2014 01
518.
Can anyone give me some feedback...
Rebecca Fein
2014 01
517.
Going electronic in the developing world?
Rebecca Fein
2014 01
516.
EMR vs EHR What is the Difference?
Nick Carter
2014 01
515.
We are in the process of helping a client transition from v5 to 6. What

[196]
were your most significant lessons learned?
Ben Brubaker-Zehr
2014 01
514.
Tablet camera as barcode scanner
Lemoene Smit
2014 01
513.
It really is true... Cloud Computing will do to traditional software what

[198]
the Internet did to newspapers.
John Jones
2013 12
33
512.
Announcement from LIMS/Laboratory Informatics - Holidays 2013
[199] Terry Iorns
2013 12
24
511.
What the top 5 lab instruments (please include manufacturer and model)
[200]
used in your lab today?
2013 12
21
[182]
[187]
[188]
[189]
[190]
[191]
[193]
[194]
[195]
[197]
Jeff Urbanczyk
146
510.
HIPAA Risk Analysis for Mobile Devices Storing or Accessing PHI

[201]
Owen Kurtin
2013 12
12
509.
Lab management structure for ISO 17025
Pujing Pan
2013 12
508.
HIPAA Business Associate Best Practices - Revised and Updated
Owen Kurtin
2013 12
507.
Useful models for empirical Risk Management: breach frequency and

damage modeling. Simple minded models that are turning out to be more
[204]
useful than ranking compliance on a scale of 1 to 5.
Don Turnblade
2013 12
506.
Regulatory Requirements for the Cloud in the US and Abroad
Jeff Urbanczyk
2013 12
505.
Is 2 Factor authentication recommended for software systems that have

PHI data regardless of whether or not it is on the local network or in the
[206]
cloud? Same question for PHI data encryption.
John Jones
2013 12
504.
Reported today by MLO "Data Innovations LLC acquires assets of

[207]
Dawning Technologies, Inc."
Matt Nielsen
2013 12
503.
How common is the Kermit protocol any more when interfacing

[208]
laboratory instruments?
Matt Nielsen
2013 12
502.
What are the choices for integration of POCT (Point of Care Testing)
[209]
with LIS and EHR systems?
John Jones
2013 11
34
501.
what is the best LIMS for petroleum Refinery and Oil field production
[210]
Naser Mansour
2013 11
25
500.
Middleware is considered to be a Medical Device Data System (MDDS)

[211]
and thus subject to FDA regulation 21 CFR part 880.
John Jones
2013 11
15
499.
Point of Care Testing (POCT) information resources. Please help by

[212]
posting your links to POCT articles and presentations
John Jones
2013 11
15
498.
Whom do you think is the decision maker or highly influential in

[213]
purchasing a LIMS or ELN systems?
Pradeep Nagisetty
2013 11
14
497.
how can i get data from WAN CLOUD on ASTM with RJ45
Khurrum Rasheed
2013 11
11
496.
Which middleware solutions do you use in your lab to integrate

[215]
instruments?
John Jones
2013 11
495.
Do you think that the LIMS market knows the difference between real
[216]
Cloud LIMS as Saas and Cloud Hosting LIMS?
Pasquale de Tullio
2013 11
494.
Looking for a LIMS for Metabolomics/Lipidomics
Manfred Raida
2013 11
493.
Any thought on saving workflows in LIMS?
[218]
Alexander Raskind
2013 11
492.
Stuck in the Middleware... little has changed
[219]
John Jones
2013 11
491.
ANY BODY give me demo laboratory system
Khurrum Rasheed
2013 11
[202]
[217]
[220]
[203]
[205]
[214]
147
490.
I would like to develop a LIMS system that can deal with both qPCR and
NGS data. Can anyone advise please with regards to suppliers, costs and
[221]
timelines.
James Clark
2013 11
489.
Are Payors starting to ask your lab for test result data? If so, what are you
[222]
doing about it?
Justin Clark
2013 11
488.
Friday prophecy about future of LIMS vendors. Whats your opinion?

[223]
Janecek Michael
2013 10
25
487.
Can you tell LIMS suitable for scientific chemistry lab? I want to store
data about the samples and the data of their research. I would be very
[224]
grateful if you could tell open source solutions
Aleksandr Iakovlev
2013 10
15
486.
The highly automated and integrated lab to the extreme
John Jones
2013 10
11
John Jones
2013 10
11
485.
[225]
Has anyone setup a wireless network dedicated for lab instrumentation

[226]
such that it is not mixed with regular network traffic?
484.
May i request you to provide me, LIMS reliability check questionaire?

[227]
Srinivasa Prasad
2013 10
483.
Which system works best for the Life Science Research Lab? Please post
[228]
a comment to elaborate
John Jones
2013 10
482.
Zebra Printer and Chinese Fonts
Gloria Metrick
2013 10
481.
Webinars on clinical labs?
Rebecca Fein
2013 10
480.
Carl Epps
Setting up a small analytical lab. Wanting to set up a LIMS system to
work with our company management information system which is Oracle.
[231]
My previous experience LIMS experience was through Thermo.
2013 10
479.
Top 50 Discussions for LIMSforum and LIMS/LI groups
John Jones
2013 10
478.
Specimen Storage - Clinical Laboratory. What are the various types of

Alerts / warnings and corrective action that user expect for the specimen
[233]
storage (all specimens in clinical lab) from LIS?
Akbar Basha
2013 10
477.
POCT1-A Protocol
Abhishek Kumar
2013 10
476.
How do typical research labs and CROs record data?
David Gurevich
2013 10
475.
Which LIS do you use in your clinical laboratory?
John Jones
2013 09
19
474.
Dear all, Please recommend the leading LIMS suppliers for R&D
(pathology, QC, Genomic research and Marker discovery applications) in
[237]
Crop science (BioAgri) space?
Hareesh Reddy
Kalavakunta
2013 09
15
473.
Do you make use of Business Analytics within your lab?
John Jones
2013 09
14
472.
How do you find good Laboratory Informatics professionals?
John Jones
2013 09
13
471.
LIMS for biotechnology
Luiz Antonio
Falaguasta Barbosa
2013 09
12
[229]
[230]
[232]
[234]
[240]
[235]
[236]
[238]
[239]
148
470.
Dear Everyone, Can anyone inform me that STAR LIMS is full compliant Asad Roman
[241]
to ISO17025? And comparison of Star LIMS with Labware
2013 09
11
469.
LIMS and ELN reseller in Brazil
Luiz Antonio
Falaguasta Barbosa
2013 09
468.
I have a starting working with a Lab that only provides urine screening
for both prescription and illegal drugs. What open source LIMS/LIS
[243]
would be the best fit for this type of Lab?
Rick Stock
2013 09
467.
HTML5 & Javascript versus native app development for mobile

[244]
applications
John Jones
2013 09
466.
Dear all, I would like to know if it is possible to engage with one LIMS
player for all Global R&D (Biotechnology) requirements? if possible,
[245]
Suggest a supplier? If not, when can this be possible?
Hareesh Reddy
Kalavakunta
2013 09
John Jones
2013 09
Shawn Douglas
2013 09
John Jones
2013 08
11
[242]
[246]
465.
All new LIMS Book & Buyer's Guide released on-line for 2013/14
464.
Public health laboratories around the world
463.
Is your LIMS/LIS integrated with EHR systems?
462.
When looking for LIMS developer consultants what is most important?

[249]
John Jones
2013 08
10
461.
Anyone successfully implement RFID sample tracking in a LIS/LIMS?

[250]
Matt Nielsen
2013 08
460.
How does your lab train and track staff training?
John Jones
2013 08
459
What article topics in the area of Laboratory & Health Informatics are
[252]
you interested in?
John Jones
2013 08
458.
GHS in Laboratory Informatics
Gloria Metrick
2013 08
457.
A simple way to improve your web browsing experience
John Jones
2013 08
456.
What's the next big thing in Laboratory, Scientific & Healthcare

[255]
Informatics?
John Jones
2013 08
455.
XML Standards for IDMI or HLA
Gloria Metrick
2013 08
454.
Do you use RSS to keep up with news?
John Jones
2013 08
453.
Can someone recommend a LIMS software package or Web based system Catherine McCord
[258]
for a small lab?
2013 07
26
452.
Open Source is racing to the top! Can it do the same for LIMS
John Jones
2013 07
24
451.
Patent Challenge
Lyndon Castro
2013 07
450.
Starlims seems to be comeup or least use Mobile Lims as their USP
2013 07
[247]
[248]
[251]
[253]
[254]
[256]
[257]
[259]
[260]
[261] Deepak Ganesan
449.
POC device data flow questions
448.
LIMS as an innovation engine
447.
149
[262]
Gail Wallace
2013 07
Avrum Goodblatt
2013 07
How we should automate bill of material for performing lab

[264]
investigations for commercial control.
Dharmendra Sharma
2013 07
446.
What is X bar chart and how can it be used for effective quality
[265]
management
Kishore Sirigiri
2013 07
445.
Good evening everybody Please! Need for help! I have searches about the Abir Kaaniche
protocol "Astm e 1381/1394" and I did not find enough explanation
[266]
concerning its functioning
2013 07
444.
What do you think about automatic approval for LIS (Laboratory

Information System). Which parameters must be in the automatic
[267]
approval system?
zgr zbek
2013 07
443.
How to find an IT testing organization accredited to ISO/IEC 17025?

[268]
Christian Blul
2013 07
442.
has anyone successfully run predictive analytics on their LIMS data? I'd
[269]
like to chat if so.
Matt Barnes
2013 07
441.
How to find a LIMS consultant to help with your LIMS project?
John Jones
2013 06
27
440.
Can anyone tell me what is the difference between customization and

[271]
configuration in the LIMS world?
Mukunth Venkatesan
2013 06
19
439.
Clarification on FDA Regulations
Jeff Urbanczyk
2013 06
15
438.
How important is it for you to be able to do ad-hoc reporting of your

[273]
LIMS data
John Jones
2013 06
15
437.
Does this article make sense to you as a LIMS users?
John Jones
2013 06
12
436.
Have you started using tablets within your lab yet?
John Jones
2013 06
435.
How important is LIMS documentation to your success with a LIMS?

[276]
John Jones
2013 06
434.
Electronic Cross Matching - Blood
Tushar Sampat
2013 06
433.
For those of you in the commercial testing labs, what CRM do you use?
[278]
John Jones
2013 06
432.
Can anyone recommend medical billing software or services?
John Jones
2013 06
431.
Could I please receive feedback on this scientific informatics resource

[280]
directory?
Shawn Douglas
2013 06
430.
LIMS Software cost in INDIA
Pradeep Divvela
2013 06
429.
Does anyone can help me in preparing the Functional Specifications for

[282]
SAP LIMS integration as in what details should be covered in that?
Suman Malik
2013 05
14
[263]
[270]
[272]
[274]
[275]
[277]
[279]
[281]
150
428.
Can anyone recommend a LIMS Solution with an offline working order

[283]
entry?
Melissa Kokel
2013 05
14
427.
Getting data in and out of Labware LIMS - preferably without files.

[284]
Advice required.
David Joyce
2013 05
10
426.
Can a Lab Analyst become a successful LIMS Administrator? It would be Priti Soni
[285]
great if people can share their thoughts or experiences on this topic.
2013 05
425.
Is there any data standard that can be used in LIMS for communicating
[286]
with Chromatography Data System?
Tushar Sinkar
2013 05
424.
Does anyone here could advise if there is any available solution

(freeware) or sourcode pertaining to Microtiter plate, that is configurable.
[287]
wherein user would be able to create templates?
Meiler Rene
Manguiat
2013 05
423.
How we can find a good LIMS Demostration to look into it? Now, I find
[288]
all Demo is so abstract!
Jason (Jian Sun)
2013 05
422.
Help for my LIS.
Jos Luis Regalado
2013 05
421.
Leesa Brieger
As part of the NSF I-Corps, program supporting transfer of technology,
we're looking to do customer discovery interviews. We're at UNC-Chapel
[290]
Hill, the technology is open source data grid software...
2013 05
420.
Has anyone implemented Mirth for exchanging data between LIS and
[291]
EHR?
John Jones
2013 04
30
419.
How should one go about learning LIMS in general or a particular LIMS

[292]
package?
John Jones
2013 04
26
418.
Blood banking and tracking software requirements
John Jones
2013 04
20
417.
What are some good solutions & techniques for Instrument Interfacing?
[294]
John Jones
2013 04
18
416.
Why there are rare LIMS Consultants with SAMPLE MANAGER

experience? we are facing difficulties in finding potential candidate for
[295]
our Client. Please let me Know the reason.
Pankaj Brohma
2013 04
17
415.
LIMS Challenges
Katie Wang
2013 04
10
414.
We are implementing LIMS in a lab that has been operating manually.

Now they need to start the stability program, does any one have idea on
[297]
how to handle samples that are already in stability chambers
Mukunth Venkatesan
2013 04
413.
What do you think of Microsoft Windows 8?
John Jones
2013 04
412.
Can a regulated industry use a standard backup software instead of a

SDMS/ECM type of solution, does the backup software need to be
[299]
compliant?
Mukunth Venkatesan
2013 04
411.
Has anyone use Bika LIMS? Is it suitable for clinical laboratories? I just
installed it, but does not look user-friendly at all, and seems slow, even
[300]
running from my local laptop.
Dominic Kojo Passah
2013 04
410.
Hi, Can anyone suggest Freeware LIMS which gives basic functionality
[301]
[302]
of LIMS. Thank you in advance.
(More comments here.
)
Ajay Lingerkar
2013 04
[289]
[293]
[296]
[298]
151
409.
LIMS compatibility with Chromeleon 7.1 for non-GMP industrial

[303]
chemistry lab?
Robert Herman
2013 04
408.
Need feedback on this 21 CFR part 11 checklist for auditing apps and
[304]
systems
John Jones
2013 04
407.
Can a regulated industry use a standard backup software instead of a

SDMS/ECM type of solution, does the backup software need to be
[305]
compliant?
Mukunth Venkatesan
2013 04
406.
Hi, can anyone suggest analytical laboratories in India who conduct tests
[306]
for Pharma Companies?
Meghna Dekhtawala
2013 04
405.
Hi, Can anyone tell me how can i learn STARLiMS package for
implementation and development and details of commercial quotes !
[307]
Thanks in advance.
Gaurang Chaturvedi
2013 04
404.
Current List of LIMS Vendors. Please check it to make sure it is accurate

[308]
and complete
John Jones
2013 03
49
403.
Hi, were doing a research about cloud-lims. Please help us answer this
question. Would you buy a Lims directly online and store your data on
[309]
external server?
Adam Wahlund
2013 03
29
402.
Why do you hate your LIMS?
Peter Nollert
2013 03
23
401.
I have a catalog of substances that i am trying to upload as an SDF. I have George Maguire
[311]
the drawings in various formats but not SDF. Any advice?
2013 03
13
400.
What is the easiest way for a lab to define their LIMS requirements?
[312]
John Jones
2013 03
11
399.
Migration of LIMS, ELN to a new platform is a big challenge these days.

[313]
Does anyone in this group experienced in this upgrade?
Somnath Mukherjee
2013 03
11
398.
Do any end-users in this group have positive or negative experiences with Angelo DePalma
LIMS or ELNs that they would like to share with the readers of Lab
[314]
Manager Magazine?
2013 03
11
397.
Measurement of Uncertainty in a LIS
Matt Nielsen
2013 03
10
396.
LIMS: Sapio Exemplar Vs. Genologics Clarity: Has anyone had

experience implementing these systems in a mid capacity NGS core. We
offer most of the NGS pipelines including Sanger sequencing. Thanks
[316]
Saikumar Karyala
2013 03
10
395.
Who provides the best technology/software solutions?
Nicola Ambler
2013 03
394.
Apps, Apps, EVERYWHERE...
[318]
Rebecca Fein
2013 03
393.
How Can Laboratory Informatics help with public health management?

[319]
Rebecca Fein
2013 03
392.
Laboratory Informatics Standards / Guides, which one should you use?

[320]
John Jones
2013 03
391.
How do NGS LIMS providers stay agile?
Arvind Sekhar
2013 03
[310]
[315]
[321]
[317]
152
390.
Which middleware products do you consider good for integrating LIS,

[322]
Instruments, EHR, etc.?
John Jones
2013 03
389.
Was Pittcon this year worth going to?
John Jones
2013 03
388.
Which middleware/s do you consider or use in bio-pharma R&D Labs?

[324]
Chintan Desai
2013 03
387.
Here is an interesting find for all you NGS LIMS folks
John Jones
2013 03
386.
Building Credibility Over Creating Temporary Happiness
Gloria Metrick
2013 03
385.
Looking for current industry thoughts on effectiveness and compliance of

multi-tenant SaaS LIMS/ERP systems. Can they be validated against
[327]
modern pharma standards?
Ryan Downey
2013 03
384.
Is it possible to sell a clinical LIMS in English to Eastern Europe

Countries - or do you have to translate it into the special languages
[328]
(Czech, Slovak, Hungarian, Polish, ..) first?
Robert Loescher
2013 03
383.
Cloud-based genetic sequencing analysis creates more privacy challenges

[329]
in genomics bit.ly/XqHcGx
Katherine "Kat" J.
McAlpine
2013 03
382.
Why Laboratory Informatics Programming is Often So Poor
Gloria Metrick
2013 02
24
381.
Request for comment on LIMS Features
John Jones
2013 02
23
380.
What interface to provide in an Instrument for good LIMS / Middleware

[332]
compatibility?
Andy Atkinson
2013 02
22
379.
Are science software archives useless?
Avrum Goodblatt
2013 02
16
378.
Data silos and you, thoughts/opinions? How do we break these things

[334]
down?
Rebecca Fein
2013 02
14
377.
Data Exchange Between Lab Equipment and Modern PCs
Steven Zobrist
2013 02
14
376.
I would like group feedback on the list of lab informatics providers shown Shawn Douglas
[336]
on the home page of LIMSwiki.org
2013 02
13
375.
Looking for scheduling software for shared lab equipment
Jens Karlsson
2013 02
12
374.
The top 10 questions about the People's Liberation Army's cyber attacks
[338]
John Jones
2013 02
11
373.
Meeting the Challenges of LIS and Data Mining

[340]
here.
)
Justin Clark
2013 02
372.
LIMS Data Structure
Stuart Lynde
2013 02
371.
Jason inspired me to do a little bit of digging on the topic of open source,

with his response to my previous question "What is the resistance to open
[342]
source?"
Rebecca Fein
2013 02
370.
Does your lab make use of a customer facing portal?
John Jones
2013 02
[323]
[325]
[326]
[330]
[331]
[333]
[339]
[335]
[337]
(More comments
[341]
[343]
153
369.
I am looking for a replacement for a GLP Cytogenetics data system for a

genetic toxicology lab. The systems needs to be 21 CFR 11 compliant.
[344]
Any recommendations out there?
Cathy Hilliard
2013 02
368.
When do busy people think!
Stormy Walker
2013 02
367.
Someone is always bragging they have a bigger one than anyone else!
[346]
John Jones
2013 02
366.
Are there any Open Source ELN systems available?
John Jones
2013 02
365.
Hamilton Robot Training Course
Gloria Metrick
2013 02
364.
Can somebody guide me for the course to take to become a laboratory

information analyst / specialist who can perform validation , compliance
[349]
and interface activity.
Syed Askari
2013 02
363.
"InvMan" - Inventory Manager by Cove Laboratory Software
Joseph Mizrahi
2013 02
362.
What's the resistance to open source?
Rebecca Fein
2013 01
20
361.
U.S. Department of Homeland Security is advising people to disable the

[352]
Java software on their computers
John Jones
2013 01
17
360.
Im looking for a good lims system for a lab that turns over abour 10000
per year. Employs 8 people and does soil and water testing. Any
[353]
suggestions?
Ruth Clinton
2013 01
17
359.
Rob Day
Thinking of building your own system? You may enjoy this interview
with small biotech that decided to build their own sample tracking system
[354]
from scratch.
2013 01
12
358.
Telling folks to stop using Java is a bit like telling the Chinese to stop
[355]
breathing air
John Jones
2013 01
11
357.
I am looking for a low cost highly functional lab middleware program to

tie in Beckman and Siemens analyzers. Looking for auto verify and qc
[356]
tracking
John Malusky
2013 01
10
356.
What is the proper role of comparison shopping in Health Informatics?

[357]
Rebecca Fein
2013 01
355.
Pathology order comms systems
Jonathan Horan
2013 01
354.
Rob Day
Thinking of building your own system? You may enjoy this interview
with small biotech that decided to build their own sample tracking system
[359]
from scratch.
2013 01
353.
Can anyone recommend an Open Source equivalent to ChemBioOffice?

[360]
John Jones
2013 01
352.
Open Source should be embraced by the lab as a very mainstream, viable

[361]
solution
John Jones
2013 01
351.
5 of the Best Free and Open Source Data Mining Software
John Jones
2013 01
[345]
[347]
[348]
[350]
[351]
[358]
[362]
350.
The challenge of open source...
349.
154
[363]
Rebecca Fein
2012 12
42
How IT will be blown to bits. Will this provide new opportunities for
[364]
science?
John Jones
2012 12
28
348.
Independent Requirements Definition Service For LIMS Projects from a

[365]
LIMS vendor? Hmmm.
John Jones
2012 12
23
347.
The cloud tipping point - 2012 seems to have been the year. When will
[366]
labs follow suit?
John Jones
2012 12
18
346.
Another funny Dilbert Cartoon related to LIMS pricing and other such
[367]
mysteries
John Jones
2012 12
15
345.
Is a Lab Execution System just another name for a LIMS?
John Jones
2012 12
13
344.
Hello Everyone, Can anyone give me an overview of the advantages of

using STARLIMS in a mining laboratory in comparison to another LIMS
[369]
system (we are currently running CCLAS-Ventix). Thanks
Adriana Sanchez
2012 12
13
343.
Experimental Planning/Design feature, is it common?
Pablo Goulart de
Queiroz
2012 12
10
342.
Serverhosting, LIMS, and GLP/GxP requirements discussion
Thijs van den Brink
2012 12
341.
We are collecting data for a client from industry professionals. Please

[372]
click the link below and answer our 1 question database survey.
Perry W. Burton
2012 12
340.
LIMS vs LIMS functionality differences
Matt Nielsen
2012 12
339.
Does anyone have a method for determination of Sodium Metabisulphate

[374]
solutions
Jacob Eko
2012 12
338.
Beware of Cloud Providers with a nuclear option... This is serious stuff!

[375]
John Jones
2012 12
337.
Does anyone know of a good resource, book, anything that harmonizes

[376]
various regulatory requirements?
John Jones
2012 11
18
336.
A problem with LIMS on an internal network
Ivan Popov
2012 11
15
335.
Automated Reporting requirements in a LIMS laboratory
Chris Johnson
2012 11
12
334.
SAP QM as LIMS
Ram Angara
2012 11
333.
LIMSwiki.org has been improved greatly. I want to thank Shawn Douglas John Jones
[380]
for the great work.
2012 11
332.
Group Member Warning! - Beware of top-paying-jobs.com
2012 11
331.
Can anyone give me their opinion on Promium vs. Sample Master/Tritan? M.J. Reider
Associates, Inc.
We are in the market for and environmental LIMS system and I have
[382]
most data on these 2 products. Can anyone help
2012 11
330.
Is any one aware of a SaaS LIMS success story?
2012 11
[368]
[370]
[371]
[373]
[377]
[378]
[379]
[383]
[381]
John Jones
Pradeep Nagisetty
155
[384]
329.
Tablet Enabled LIMS
Terry Iorns
2012 11
328.
LIMS consultant
Dieter B.
2012 11
327.
Automated Reporting requirements in a LIMS laboratory
[386]
Chris Johnson
2012 11
326.
Are serial port based instruments still common in the lab?
[387]
John Jones
2012 10
24
325.
Is there a reason for a lack of innovation in the LIMS industry?
John Jones
2012 10
17
324.
Dear All, Our lab is looking for a free Clinical LIMS software. We have
[389]
downloaded few applications in the web
Meiler Rene
Manguiat
2012 10
17
323.
hi all , is it necessary to have our LIMS software validated by the FDA to

sold and install it in the US ? some of my friends says no and others said
[390]
yes ......Thanks for your informations...
Frederic Buisson
2012 10
11
322.
Use of digital signatures on final reports
Neill Rosenthal
2012 10
10
321.
Article: Experiencing Product Maturity: ELNs and LIMS
Helen Gillespie
2012 10
320.
Ad-hoc queries
Phillip Woodhouse
2012 10
319.
If you had to pick one mobile device, which would you choose?
John Jones
2012 10
318.
Any experience in Directory Watch, Nugenesis, ComplianceBuilder or

other application that monitors disk folders or server shares for file
[395]
modification/deletion?
David Bird
2012 10
317.
What tools do you use to describe graphically what your lab does?
John Jones
2012 10
316.
Instruments to LIMS interaction via HL7 instead LIS02/LIS01 (ASTM)

[397]
any experiences?
Guillaume Duroux
2012 10
315.
Thermo Scientific Watson LIMS and Instem Provantis
Cristino Damo
2012 10
314.
Do it Yourself (DiY) LIMS. Is it right for your lab? Are you a software
[399]
developer or a lab?
John Jones
2012 09
26
313.
ASTM E-1394-97 standard : Message structure
Charbel Roumi
2012 09
22
312.
The DiY LIMS... Does this Dilbert cartoon remind you of anything?
[401]
John Jones
2012 09
18
311.
Switching from a paper lab notebook - help and suggestions needed.

[402]
Pawel Lorkiewicz
2012 09
14
310.
In the environmental analytical contract lab industry, are value-added

[403]
services becoming "the norm" and part of clients' expectations?
Katharine Kaye
2012 09
12
309.
LIMS final reports and the need to edit those reports
John Jones
2012 09
12
[385]
[388]
[391]
[392]
[393]
[394]
[396]
[398]
[400]
[404]
156
308.
I had some questions regarding LIMS pricing 1) Typically are user

licenses & server renewed on an annual basis? I read through the 2012
[405]
buying guide and I wasn't clear on this. Thanks!
Robert Melkus
2012 09
12
307.
Web Browser based apps have been the trend for about 10 years now.
[406]
What is next?
John Jones
2012 09
306.
ASTM message reader / editor
Charbel Roumi
2012 09
305.
Web Browser based apps have been the trend for about 10 years now.
[406]
What is next?
John Jones
2012 09
304.
Anyone have any experience with good document management software

to help with CAP/CLIA inspections? I've heard good things about Genial
[408]
(Geneial) - anyone else?
Keith McCormick
2012 09
John Jones
2012 09
Jeffrey Lee
2012 09
[407]
[409]
303.
A pretty cool example of the power of HTML 5
302.
Which direction will we see with lab informatics apps?
301.
With all the excitement about Mobile Technology, do you currently use a
[411]
Smart Device at your work?
John Jones
2012 09
300.
We want to develop web based LIMS for small companies like Pharma,
[412]
Food, Cosmetic, Public testing laboratories, etc.
Lal Chand Kumawat
2012 09
299.
Does anyone have any experiences in Technicon RA-XT Laboratory

[413]
Interfacing?
Kaveh Eshkofti
2012 09
298.
Are there any LIMS that integrate requirements about Validation of

[414]
Analytical Methods? Which of them?
Allan Max Alves de

Carvalho
2012 09
297.
What's the Hot, New Thing?
Gloria Metrick
2012 09
296.
In the environmental analytical contract lab industry, are value-added

[416]
services becoming "the norm" and part of clients' expectations?
Katharine Kaye
2012 09
295.
Standards, standards everywhere and not a solution in sight. Does anyone

[417]
care?
John Jones
2012 09
294.
At Millennium we are examining different software solutions (that can be

validated) to monitor our laboratory environmental chambers. I'm
[418]
interested in learning what folks are using in this space.
David Sedlock
2012 09
293.
When a vendor releases is new version of their software and the data
model is fundamentally changed, should this be classified as an
UPGRADE, MIGRATE or NEW SYSTEM? What is our experience and
[419]
opinion?
Peter Boogaard
2012 09
292.
Can Open Source be the next disruptive innovation for LIMS / LI
John Jones
2012 09
291.
When defining your lab's informatics requirements, what are the key
[421]
points to cover?
John Jones
2012 08
29
290.
Announcement from LIMS/Laboratory Informatics- 8/14/2012
[422]
Terry Iorns
2012 08
24
289.
Are LIMS and LIS the same thing?
John Jones
2012 08
21
[410]
[415]
[423]
[420]
157
[424]
288.
Is there much diffeence in chemstation and empower
Shital Yadav
2012 08
21
287.
How do you use laboratory informatics tools / processes to support lean

[425]
[426]
concepts in your lab?
(More comments here.
)
Katharine Kaye
2012 08
14
286.
NGS LIMS
Alex Birch
2012 08
11
285.
How do you use laboratory informatics tools / processes to support lean

[426]
concepts in your lab?
Katharine Kaye
2012 08
284.
Risks to using hosted LIMS...cloud based or otherwise.
Kevin Cramer
2012 08
283.
CLIA (Clinical Laboratory Improvement Amendments) & Proficiency

[429]
Testing
Paula J. Magnanti
2012 08
282.
'Shadow IT' can be the cloud's best friend
John Jones
2012 08
281.
Trouble-Free Science With A Cloud LIMS
Julio Peironcely
2012 08
280.
Experiences with LabDAQ ?
John Alsobrook
2012 08
279.
Does anyone has experience with Moving Average practice into LIS or
[433]
middleware?
Sauro Grandi
2012 08
278.
What do you use for Data Mining, especially in drug discovery ?
Johann Lauthier
2012 07
19
277.
Open Source alternative to the forms based Nexus ELN
John Jones
2012 07
14
276.
Is there a list of LIMS, ERP or SDMS solution that are based (or at least
[436]
able to manage) chemical structures?
Lionel Colliandre
2012 07
14
275.
Thoughts about our current Logo
[437]
Alex Birch
2012 07
14
274.
Suggestions on how to migrate LIMS data from a legacy LIMS to a new

[438]
LIMS
John Jones
2012 07
273.
Forecasting public cloud adoption in the enterprise
John Jones
2012 07
272.
Is the future of Open Source to become Open SaaS?
John Jones
2012 07
271.
Me and my partner planned to to start a pathology lab, can anyone

[441]
suggest me where can I buy LIMS for cheaper rate.
Ankur Shah
2012 07
270.
New course: R/D Technology for IT Professionals
Joe Liscouski
2012 07
269.
Go Big or Go Home? - Whether to Utilize a Large National Lab or a

[443]
Smaller Local Lab
Justin Davis
2012 07
268.
This is a good sign for cloud computing in the scientific enterprise
John Jones
2012 07
267.
Buried under the deluge of data impacting your lab?
R. Brian Potter
2012 07
[427]
[428]
[430]
[431]
[432]
[434]
[435]
[439]
[440]
[442]
[445]
[444]
158
266.
Does "Big Data" apply to Lab Informatics in ways other than Next
[446]
Generation Sequencing (NGS)?
John Jones
2012 06
26
265.
Has anyone compared the Open Source GNomEx LIMS to the proprietary John Jones
[447]
Exemplar LIMS?
2012 06
12
264.
Stand alone Blood Bank application.
2012 06
12
263.
I am curious... Has anyone in this group found a job because of this group John Jones
[449]
or any group on Linkedin?
2012 06
262.
I am looking for reliable and fraud-proof biometric identification system Heloisio Rodrigues
that could be linked to clinical report forms. I would appreciate any input.
[450]
2012 06
261.
Calibration Manager Recommendation
Jeffrey Lee
2012 06
260.
What do you use for Laboratory Instrument Utilization Software?
Howard Rosenberg
2012 06
259.
Hi, I am looking for an off the shelf Metrology LIMS any ideas?
Allan Mujukane
2012 06
258.
Hurdles for instrument / LIMS interface
John Alsobrook
2012 06
257.
I'm looking for experts and users of laboratory information systems of all
types. I'm writing an article on the subject for Lab Manager Magazine
[455]
(labmanager.com). Please respond to angelodp@gmail.com
Angelo DePalma
2012 06
256.
What should be the differentiation factor for Lab automation service

[456]
providers?
Deepak Ganesan
2012 06
255.
Mouse colony management in LIMS
Mathieu Wiepert
2012 06
254.
Does Open Source have some advantages when it comes to validation?

[458]
John Jones
2012 05
27
253.
Suggestions for an inexpensive barebone LIMS
Pujing Pan
2012 05
19
252.
2012 LIMS Buyer's Guide now available for download
John Jones
2012 05
14
20
251.
What is the most important trend for Lab Informatics Software?
John Jones
2012 05
12
250.
Consumerization of IT, will this be a trend for Laboratory Informatics?

[462]
John Jones
2012 05
249.
Looking for local LIMS experts to join the panel at the lab conference
[463]
which will be held in Sydney Australia this September.
Katie Wang
2012 05
248.
Announcement from LiMS forum - Regarding job postings
John Jones
2012 05
247.
Which type of software license is of best value?
John Jones
2012 05
246.
For those interested in DiYBio and the building your own Thermal PCR,
[466]
check this out
John Jones
2012 05
[448]
Rodney Tinsley
[451]
[452]
[453]
[454]
[457]
[459]
[460]
[461]
[464]
[465]
159
245.
Cloud Computing Usage in Biotech & Pharma Market Study
244.
[467]
John Jones
2012 05
Functional Requirements when defining out development in a LIMS

[468]
system. How far do you go and how far is not far enough.
Peggy Weber
2012 05
243.
It's time to run Java out of town, are LIMS built on Java the next to go?
[469]
John Jones
2012 04
44
242.
Is there any use or need for a Wiki in the laboratory?
John Jones
2012 04
32
241.
Anyone know of a solid QBD (quality by design) program for small scale
[471]
PD? Needs to be OPC
Matt Barnes
2012 04
14
240.
Are there any good work group collaboration tools that can be an
[472]
alternative to a LIMS?
John Jones
2012 04
10
239.
Forensics Laboratory Fraud: Is the foundation of so called Forensics

[473]
Science in question?
John Jones
2012 04
238.
Hi, did anyone use a LIMS for sequencing core facility? I am now testing
Gnomex wich is open source and designed for highthrouput sequencing
[474]
platform. That looks to give us satisfaction.
Mohammed-Amin
Madoui
2012 04
237.
Would like feedback on an idea to improve the group
John Jones
2012 04
236.
Is the iPad the future of lab data management and scientific collaboration? Rob Day
[476]
2012 04
235.
I need help with some LABVANTAGE Solutions branding issues I'm

[477]
encountering
Shawn Douglas
2012 04
234.
Has anyone integrated a LIMS and a Manufacturing Execution System

[478]
(MES)?
John Jones
2012 04
233.
ASTM Standard LIMS Guide - Webex Meeting on April 26th
John Jones
2012 04
232.
What keeps you from getting a LIMS for your lab?
John Jones
2012 04
231.
Amazon offers cloud apps at hourly rates from IBM, SAP, others - what
[481]
about LIMS and ELN
John Jones
2012 04
230.
Gran berg
I'd like to know the average no of tests/samples made per year in a lab
and of that portion what results are STAT in percentage. If someone could
[482]
provide data it would be great!
2012 04
229.
Some estimates indicate that around 95% of all chain of custody forms
submitted to environmental labs are paper forms. Is this metric about the
[483]
same for other types of labs (pharma, medical, etc)?
James Young
2012 04
228.
Use of Dropbox and any similar tools in the lab
Terry Iorns
2012 04
227.
Is a LIMS the platform of choice for the future "Integrated Lab"
John Jones
2012 03
36
226.
What is the difference between a LIS and a LIMS?
John Jones
2012 03
24
[470]
[475]
[479]
[480]
[484]
[486]
[485]
160
225.
Does anyone use a Serial-to-Ethernet device to interface lab software to

[487]
serial instruments?
John Jones
2012 03
24
224.
Today, Excel is widely used for data capture/performing some basic data
analysis tasks. Based on our study, we found below listed challenges
[488]
..Read More
Siva Venugopal
2012 03
23
223.
How would you rate the quality of Open Source Software compared to
[489]
commercial software
John Jones
2012 03
22
222.
What type of User Interface do you prefer for your LIMS?
John Jones
2012 03
20
221.
Laboratory Informatics Consulting: A Better or Worse Profession?
Gloria Metrick
2012 03
11
220.
What is the best LIMS for next-generation genomics/Sequencing

[492]
samples?
Chintan Desai
2012 03
10
219.
Documenting and diagramming business processes
James Smith
2012 03
10
218.
Do Nutraceutical manufacturers fall under GAMP 5 or 21 CFR part 11 or

[494]
is it purely optional?
John Jones
2012 03
217.
Can cloud hosted work flow be integrated with an existing LIMS or lab
[495]
process?
Murray Oles
2012 03
216.
Tell me some good soultions for laboratory management ( free wares that
[496]
can be developed internally)?
Saim-Ul-Haq
Quddusi
2012 03
215.
What is the best option for a LIMS for a small services lab?
Manuel Lolo
2012 03
214.
Does anyone use openELN from Amphora?
John Jones
2012 03
213.
Question for laboratories on the log-in process: How much does it cost
your lab, on average, to enter a client's chain-of-custody form manually
[499]
into your LIMS?
Karen Baer
2012 03
212.
ASTM Standard LIMS Guide is Up for Revision All Interested

[500]
Stakeholders are welcome to join the revision effort.
James Powers
2012 03
211.
Would you want to "Test Drive" lab informatics software before you buy
[501]
it?
John Jones
2012 03
210.
Does your LIMS need a "Tune-up"?
John Jones
2012 03
209.
Documenting and diagramming business processes
James Smith
2012 03
208.
ASTM Standard LIMS Guide is Up for Revision All Interested

[504]
Stakeholders are welcome to join the revision effort.
James Powers
2012 03
207.
Does anybody have experience with any of the open source lims? If so
[505]
which ones?
John Bishop
2012 03
206.
Dos and Donts for Strategic Planning of Laboratory Informatics
Unknown
2012 03
205.
Laboratory Key Performance Indicators (KPI)... what KPI measurements

[507]
does your lab use?
John Jones
2012 03
[490]
[491]
[493]
[497]
[498]
[502]
[503]
[506]
204.
Agricultural Industry LIMSWiki Article
203.
LIMSWiki page on LIfe Sciences
161
[508]
Jeffrey Lee
2012 03
[509]
Jeffrey Lee
2012 03
202.
The most comprehensive list of LIMS Vendors / Products in the industry

[510]
John Jones
2012 02
83
40
201.
What LIMS systems do you have experience with?
Jason Pelish
2012 02
58
200.
Please anyone know how to plot histogram for Pentra-60 Hematology

[512]
anlayzer, do reply...
Shyam V.
2012 02
26
199.
Open Source Data Integration... Could use some help with this project
[513]
John Jones
2012 02
24
198.
What industries are served by LIMS?
Jane de Lartigue
2012 02
23
197.
What defines a laboratory?
Jane de Lartigue
2012 02
21
196.
Has anyone purchased any of the LIMS Market Research reports?
[516]
John Jones
2012 02
16
195.
When researching which LIMS or ELN to buy, would you prefer an

Independent LIMS consultant or one that works with a handful of select
[517]
LIMS products?
John Jones
2012 02
15
194.
LIMS Consultant vs. LIMS Contractor. What is the difference?
John Jones
2012 02
14
193.
Is anyone interested in evaluating the Agilent OpenLab ELN?
John Jones
2012 02
11
192.
Its been a while since I posted in this group Our LIMS team is growing as Anu Acharya
[520]
it should...
2012 02
10
191.
Does anyone in the Group use Open Source LIMS or Lab Software in
[521]
their lab?
John Jones
2012 02
10
190.
What is your biggest concern about Cloud Applications?
Eran Ohayon
2012 02
189.
Can anyone help me find Tissue Typing LIMS requirements

[523]
specification?
John Jones
2012 02
188.
Candidate LIMS for Food Analysis Laboratory in Argentina
Alejandro Pesce
2012 02
187.
Understanding how to implement an effective Laboratory Automation

[525]
Informatics System
Samuel Marsden
2012 02
186.
Software for Taste Panels
Terry Iorns
2012 02
185.
Does anyone know a Joomla extension used to develope LIMS?
Dawit Zewdu
2012 02
184.
Four Principles of Quality Systems
Jon Nugent
2012 02
183.
How to get LabWare Administrator Certification
Mimi Su
2012 02
[511]
[514]
[515]
[518]
[519]
[522]
[524]
[526]
[528]
[529]
[527]
182.
Use Cases vs Simulations
181.
162
[530]
Judith Hennen
2012 02
Will Cloud Computing do to licensed software companies what the

[531]
internet did to magazines & newspapers?
John Jones
2012 01
75
180.
List of Cloud based Lab Informatics applications. Please suggest others

[532]
you know of.
John Jones
2012 01
29
179.
Here's a question for LIMS professionals: Do you have professional

[533]
laboratory experience where you've performed tests and analyses?
Jason Pelish
2012 01
26
178.
Which Laboratory Informatics system is most applicable for your lab and
[534]
why?
John Jones
2012 01
11
177.
What represents the best reason for getting a LIMS? Add comments on
[535]
what is important to your lab.
John Jones
2012 01
11
176.
Global Laboratory Information Management Systems Market to Reach

[536]
US$1.4 Billion by 2015
John Jones
2012 01
175.
How would you prefer your LIMS to resolve sample and preservation
[537]
relationships?
Lemoene Smit
2012 01
174.
Does anyone know how many independent laboratories exist? What

percent are in chains? (I'm also looking for similar information on
[538]
pharmacies). Sources are appreciated.
Rita Torkzadeh
2012 01
173.
Need recommendation for a formula management system
Tom Quinn
2012 01
172.
Validation Document Requirements
Jon Nugent
2012 01
171.
Accelrys has acquired Velquest
Terry Iorns
2012 01
170.
Would Like Comments on ELN Evaluation Project
Amlie Bouilly
2012 01
169.
Workflow management system for instrument results.
Unknown
2012 01
168.
I am looking for ICD9 to ICD10 code mapping database, any guidance

[544]
will be a big help. Thanks
Siva Venugopal
2012 01
167.
LIMS & QMS in one?
J.P. Woods
2012 01
166.
White Paper: Learn Best Practices for Lab Chemical Inventory

[546]
Management
Brian Stafford
2012 01
165.
What are some of the key functional requirements of an ELN for

[547]
Research and for QA/QC?
John Jones
2012 01
164.
How would you prefer your LIMS to resolve sample and preservation
[548]
relationships?
Lemoene Smit
2012 01
163.
Can some one provide information on APQR (Annual Product Quality

[549]
Review) and it's interfaces with LIMS?
Pavinder Bola
2012 01
162.
Medieval Tech Support for your Laboratory Notebook
John Jones
2012 01
[539]
[540]
[541]
[542]
[543]
[545]
[550]
163
[551]
161.
GMP vs. non-GMP
Gloria Metrick
2012 01
160.
List of Open Source LIMS
John Jones
2011 12
35
159.
Which metric is most important to you when considering a LIMS vendor? John Jones
[553]
2011 12
29
158.
Is an open source LIMS or ELN practical for use in GxP environments?

[554]
John Jones
2011 12
22
157.
Would you use a Cloud Hosted LIMS for your lab?
John Jones
2011 12
20
156.
Which type of LIMS platform do you prefer?
John Jones
2011 12
17
155.
Would you build a LIMS in Fortran? How about SmallTalk?
John Jones
2011 12
Jason Pelish
2011 12
John Jones
2011 12
Akram Ansari
2011 12
[552]
[555]
[556]
[557]
154.
During LIMS implementations, what metatools do you use to manage

[558]
requirements, traceability and quality control?
153.
Which database do you prefer for you LIMS?
152.
Iron removal in nano form from drinking water
151.
No overtime for IT? Lawmakers want to take away overtime pay for
[561]
thousands of IT workers. What's wrong with these people?
John Jones
2011 12
150.
Has anyone implemented SCC SoftGenetics? How was your overall

[562]
experience?
Jun Kim
2011 12
149.
Any recommendations for good LIMS training institutes in NJ/PA area. [563]
Please write to me on achinnam@hcl.com
Adan Newman
Chinnam
2011 12
148.
How do labs want their LIMS to handle Time Zones where there are
[564]
multiple lab sites?
John Jones
2011 12
147.
Manage stock from a small service lab unit
Joo Sobral
2011 11
25
146.
What tools do you use for LIMS data migration
John Jones
2011 11
11
145.
does anyone know about any LIMS software for oil analysis laboratories? Saugata Roy
[567]
2011 11
144.
eDMS integration with LIMS : how is it imprortant
Orang Gholikhani
2011 11
143.
Does anyone know of any free or open source SPC charting software?
[569]
John Jones
2011 11
142.
Manage stock from a small service lab unit
Joo Sobral
2011 11
141.
LIMS Data Quality
Louis Hendriks
2011 11
140.
What domains of science do the makers of LIMS see converging and

[572]
diverging?
Kevin Garwood
2011 11
[559]
[560]
[565]
[566]
[568]
[570]
[571]
164
139.
I have a LIS Question. When converting from one test to another test is it
possible to build a code to prevent doctors from repeat ordering of that
[573]
same type of test?
Tim Ayotte
2011 11
138.
Is there a source for lab normal values that is reliable for reference. I
know normal values will vary depending on population, gender, age etc.
[574]
so would like to have something with these attributes.
Rajesh Kajale
2011 11
137.
With 100's of LIMS and other Lab Informatics systems on the market,
what questions should be asked to narrow the list of systems to look at?
[575]
John Jones
2011 11
136.
Please, can somebody suggest a standard textbook for laboratory

[576]
management???
Thota Parvathi Ram
2011 11
135.
When converting from one test to another test is it possible to build a

code that will prevent doctors from ordering repeats of that same type of
[577]
test?
Tim Ayotte
2011 11
134.
Does anyone use Amazon Cloud Services for hosting software for
[578]
regulated laboratory environments?
John Jones
2011 10
19
133.
We planning to implement LIMS in our four labs supporting mining and

metallurgical operations.... Anyone with information on the LIMS
[579]
systems on the market suitable for mining environment ...Thanks
Humphrey Nkobeni
2011 10
18
132.
The LIMSource is gone and so is the content.
John Jones
2011 10
14
131.
Some LIMS manage data file from instruments, from a GLP point of
view, witch is the data that you generaly consider as "Raw Data": the
[581]
binary files or the analytical reports from instruments ?
Sebastien Siret
2011 10
13
130.
Is an ELN simply a module of a LIMS?
John Jones
2011 10
12
129.
To Buy or to Build a LIMS?
John Jones
2011 10
128.
News From LIMS/Laboratory Informatics: 11 OCT 2011
Gloria Metrick
2011 10
127.
Is an ELN simply a module of a LIMS?
Judith Hennen
2011 10
126.
We need some expert help in doing a thorough evaluation of a particular

[585]
ELN
John Jones
2011 10
125.
Does anyone know of mid-size consulting / implementation / support /

professional service vendors for Laboratory solutions including Labware
[586]
LIMS?
LuAnn Ucker
2011 10
124.
Looking for lims vendor in germany, for a german based lims software
[587]
company
Alexander Garcia
2011 10
123.
A Not so Authoritative Look at What Cloud Terms Mean
Richard Sink
2011 10
122.
How long does it take to 'stand up' a LIMS environment in the cloud?
[589]
Alan Forsythe
2011 10
[580]
[582]
[583]
[584]
[582]
[588]
165
121.
I wish to learn HPLC (Agilent and Waters system) in Chicagoland area. I

am open to internship, training in University, pharma company. Any
[590]
recommendations/suggestions would be helpful. Thanks !
Richa Bedi
2011 10
120.
We are looking for a small and online LIMS for biological lab. If you
have original code(php+mysql), we hope buy or cooperate with you. If
[591]
you have any interest, we would like to communicate with you.
Paul Zhang
2011 09
26
119.
Recruiting in Laboratory Informatics
Gloria Metrick
2011 09
25
118.
Has anyone implemented SAP QM for LIMS application? I would be

[593]
interested to hear.
Raghu Rajagopal
2011 09
15
117.
Does anyone have any experience in using the Quartzy LIMS?
John Jones
2011 09
13
116.
Is a general LIMS sufficient for Biobanking facilities?
Tom Hoksbergen
2011 09
13
115.
I'm looking for a LIMS for a small biochemical lab and would appreciate
[596]
the insights of the group. Any suggestions?
Dave Kuchta
2011 09
10
114.
Azamat Kaldarov
Dear friends, Could you advice me, how I can find the university, which
encloses of teaching Lab equipments, such as GC or LC ( with NPD, FID,
[597]
TCD e.t.c), Turbidimeter, AAS, Spectrophotometer e.t.c.
2011 09
113.
Does anyone have experience working with the individuals who build
[598]
CPT codes for the LIS system in a hospital?
Tim Ayotte
2011 09
112.
News From LIMS/Laboratory Informatics: 09 SEP 2011
Gloria Metrick
2011 09
111.
Looking for *free* online ELN.
Gustavo Seabra
2011 09
110.
Impacts of Housing Market Decline on Recruitment in Perm Placement

[601]
Sector
Brenda Witkemper
2011 09
109.
Is this LIMS group useful to you?
John Jones
2011 09
108.
Is any organization looking at automating their compliance related quality John Bridwell
control in the lab using auto identification technology like RFID? Thanks!
[603]
2011 09
107.
John Trigg's - Where Do the Ideas Come From? An editorial on

[604]
Laboratory Knowledge Management
2011 09
106.
Is any organization looking at automating their compliance related quality John Bridwell
control in the lab using auto identification technology like RFID? Thanks!
[605]
2011 09
105.
I'd like to know what software packages are in use to work with PDF
documents and their extraction to jpg images. We have some processes
[606]
that require we extract 'x' number of pages from a PDF.
Bobby Sims
2011 09
104.
I work with an environmental laboratory and we are looking to capture

instrument data electronically and maintain and track that data with an
[607]
audit trail and electronic signatures.
Chris Lapallo
2011 08
22
103.
Is there any online course to learn LiMS?
Ketki Patil
2011 08
15
[592]
[594]
[595]
[599]
[600]
[602]
[608]
John Jones
166
[609]
102.
Discussion Guidelines: Fairness
Gloria Metrick
2011 08
15
101.
What LIMS products are people using to support ADME studies?
[610]
Terry Iorns
2011 08
10
100.
Has anyone developed any applications of the Netduino for Laboratory

[611]
Informatics?
John Jones
2011 08
099.
Is anyone looking for LIMS specially for Biotechnology / Lifesciences

[612]
research data management?
Vijay Gunasekaran
2011 08
098.
Free / Open Source Group Managing Software?
Gustavo Seabra
2011 08
097.
Joanne Dawn
Hi, can I ask do LIMS vendors offer Electronic Medical Records? It
seems there might be a synergy between the two? I would love to connect
[614]
with you as I am new to the HIT field in journalism.
2011 08
096.
I am trying to find out low cost LIMS product available at UK. Can
[615]
anyone help me with a site/list?
Somnath Mukherjee
2011 07
22
095.
Is There A Difference Between SaaS and Cloud Computing?
William Signer
2011 07
13
094.
I have never posted any rules on how this group is to conduct itself. I got
[617]
bored and decided to write up some. Check them out.
John Jones
2011 07
10
093.
ECR
Gloria Metrick
2011 07
092.
Any LIMS expert who can do a corporate training for a client in

[619]
Bangalore?
Ravi Kariparambil
2011 07
091.
Is there a downloadable trial version of labware/eln software?
James Herman
2011 07
090.
Combined Systems: LIMS/ELN
Gloria Metrick
2011 06
33
089.
Laboratory informatics conference-- What kinds of things would you like

[622]
to see at such an event?
Caroline Buerkle
2011 06
13
088.
LIMS in Brazil
Melissa Feddis
2011 06
12
087.
Why do lab informatics projects succeed?
Mike Molloy
2011 06
11
086.
I'm looking for flexible Reporting Solutions against ThermoFisher

[625]
Sample Manager 9.x Any recommandations from this Group?
Frank Wahl
2011 06
10
085.
Would anyone be willing to help out on researching and writing content

[626]
for the LIMS wiki?
John Jones
2011 06
084.
Could someone help me to get Rubacha, M., Rattan, A.K., Hosselet, S.C.: Alexander Garcia
A review of electronic laboratory notebooks available in the market
[627]
today. J Lab Autom 16 90-98
2011 06
083.
Laboratory informatics conference-- What kinds of things would you like

[628]
to see at such an event?
Caroline Buerkle
2011 06
082.
Biomarker discovery protocols (Open access)
Tonny Johnson
2011 06
[613]
[616]
[618]
[620]
[621]
[623]
[624]
[629]
167
081.
Looking for Tissue banking software for our hospital registry.Should be

either free software or low priced software.Anybody can recommend one
[630]
?
Ramkumar
Ashokkumar
2011 06
080.
News From LIMS/Laboratory Informatics: 30 JUN 2011
Gloria Metrick
2011 06
079.
Achieving a fully integrated, data, information and Knowledge

[632]
management environment is this really possible??
Craig O'Dell
2011 05
31
078.
LIMS in manufacturing seems to me to have a negative trend
John Jones
2011 05
16
077.
Any suggestions for a LIMS to be used in manufacturing, QC, and

packaging processes? Preferably compatible with common software and
[634]
capabilities to communicate with other information systems.
Kelly Hedlund
2011 05
15
076.
Will Cloud Computing make a commodity of LIMS & IT in general?

[635]
John Jones
2011 05
075.
Is there anyone within our group here that has experience with
Chromeleon? We are getting involved in a project and was hoping to
[636]
network with a subject matter expert.
Russell Abraham
2011 05
074.
Open source
Sidlei Jardim
2011 05
073.
Web Based LIMS and the Cloud - Be Aware of Major Security Concerns
[638]
for Years to come
Kevin Cramer
2011 05
072.
Relevance of LIMS in a Medical Device Company
Vishal Degwekar
2011 05
071.
Do we need a new term to descibe systems that manage Laboratory

[640]
Information?
John Jones
2011 04
111
070.
Linkedin Poll: Why do many Lab-Informatics (LIMS, ELN, SDMS etc)

[641]
projects fail to reach the desired result? In-time & on-budget.
Louis Uunk
2011 04
28
069.
How to check references of a LIMS Consultant?
John Jones
2011 04
20
068.
Could anyone recommend an online service that would help manage a

[643]
lab?
John Jones
2011 04
11
067.
Does anyone use RFID in the lab and is there really any practical use in
the lab? While RFID works for book stores, libraries and places where
[644]
you worry about theft, does it really work for the lab?
John Jones
2011 04
10
066.
LIMS for MAC environments?
Bill Tumbleson
2011 04
10
065.
Did any of you implemented an ELN system together with LIMS

[646]
(Labware)?
Amit Sheinfeld
2011 04
10
064.
With the proliferation of 2D barcodes is there any reason for a lab to

[647]
continue to use the old traditional 1D barcodes?
John Jones
2011 04
063.
What are some trends that LIMS consultants are seeing in the Laboratory
[648]
Informatics marketplace when it comes to the consulting business?
John Jones
2011 04
062.
Does anyone can suggest a good compromise LIMS solution to manage

[649]
analytical and bioanalytical processes?
Monica Dongili
2011 04
[631]
[633]
[637]
[639]
[642]
[645]
168
061.
Crucial Decision: What to choose; Quality Data or Save Precious Time

[650]
Tushar Sinkar
2011 04
060.
What are your experiences with Cloud Computing in a Regulated

Environment (FDA) Good and Bad? What challenges have you had to
[651]
overcome for successful implementation?
Joseph Franchetti
2011 04
059.
I think we all know that MS-office is used the most by labs to create data
management systems. Is there a possibility for the equivalent SaaS app
[652]
that can work better for the lab?
John Jones
2011 04
058.
Linkedin Poll: Why do many Lab-Informatics (LIMS, ELN, SDMS etc)

[653]
projects fail to reach the desired result? In-time & on-budget.
Louis Uunk
2011 04
057.
Does anyone in this group use an SDMS (scientific data management

[654]
system)?
John Jones
2011 03
36
056.
Just published ....... SAP QM vs LIMS
Robert Pavlis
2011 03
23
19
055.
Does anybody know if it is possible to run LIMS in virtual machine

[656]
VMware media?
Siri H. Segalstad
2011 03
21
054.
Lab Scheduling Software
[657]
Stu Miller
2011 03
17
053.
Lab Scheduling Software
[658]
Stu Miller
2011 03
12
052.
SharePoint 2010 and 21 CFR Part 11 Compliance
Joseph Kofman
2011 03
10
051.
caBIG (cancer Biomedical Informatics Grid) Professional Network Group John Jones
[660]
2011 03
10
050.
How do you verify a LIMS interface?
Bruce Levkoff
2011 03
049.
I am teaching some health care science undergraduates about health

informatics. What are the key messages I should get across in a two hour
[662]
session?
Richard Hayward
2011 03
048.
Data Visualization can be an important LIMS tool
John Jones
2011 03
047.
Can anyone share some examples of how they are using 2D barcodes in
[664]
the lab?
John Jones
2011 03
046.
How to best design a chemical sensor to be most compatible with all

[665]
LIMS systems
Scott Sutherland
2011 03
045.
Human Leucocyte Antigen (HLA) Typing/Cellular Transplant Therapy

[666]
Gloria Metrick
2011 03
044.
The LIMS Buyer's Guide was recently released at PIttcon. I wanted to

poll the group members and see if users think a LIMS price list is of use.
[667]
John Jones
2011 03
043.
Ordering Lab supplies?
Muhammad Siddiqui
2011 03
043.
Which LIMS system are you mainly using in pharmaceutical QC &

[669]
production?
Helge Tippmann
2011 03
[655]
[659]
[661]
[663]
[668]
169
042.
Is anyone using MS Sharepoint as ELN, LIMS or LIS? I have a client

who is using Sharepoint for Regulatory Compliance document
[670]
management. I was wondering if anyone is using it in the lab?
Steven Roll
2011 03
041.
QA/QC ELNs)
Gloria Metrick
2011 02
24
040.
Anyone with experience using pre-configuration packages?
Unknown
2011 02
24
039.
I work for a chemical company that is integrating SAP early next year.
Has any labs switched to SAP? If so, is the SAP QM suitable to replace a
[673]
LIMS or is both still needed?
Joe McMullen
2011 02
15
038.
What it takes to find a suitable Bioinformatics specialist
Jinliang Sui
2011 02
12
037.
This is a first! I just found a LIMS Poem of all things. It's too funny
[675] John Jones
2011 02
11
036.
Is there much demand for time tracking in a LIMS?
John Jones
2011 02
035.
Pharmaceutical development. Process of archiving the raw data (in

particularly produced during the formulation and analytical processes)
[677]
Anglica Cavalcante
Galvao
2011 02
034.
Is the Labware LIMS available through GSA?
John Jones
2011 02
033.
Off-shelf data management system for clinical and physiological study

[679]
Dong Zhang
2011 02
032.
I am really interested in using the Laboratory Information Management

System (LIMS) to record dat and create reports. I would be pleased if
[680]
anybody helps with a good source to learn fast. Fatima
Fatima Khanloo
2011 02
031.
Is PerkinElmer leaving the LIMS business?
John Jones
2011 02
030.
Which report design software do you use with your LIMS? How would
[682]
you rate it?
John Jones
2011 02
029.
LIMS in the in-process testing department
Nick Chen
2011 02
028.
Where is the LIMS industry headed?
John Jones
2011 01
38
027.
Steven Roll
We are looking for a LIMS that will upon entering a sample create all
fractions (aliquots) at multiple levels (fractions of fractions) and assign all
[685]
tests applicable to each fraction type.
2011 01
22
026.
LIMS ROI
Hagai Kaplan
2011 01
14
025.
Can an antiquated LIMS (Perkin Elmer Labworks) system be upgraded

[687]
without spending hundred of thousands of dollars?
Melissa Higgins
2011 01
13
024.
I am searching a LIMS for In Vitro Life sciences studies.
Sebastien Siret
2011 01
11
023.
Animal studies /tumor studies software
Bob S.
2011 01
[671]
[672]
[674]
[676]
[678]
[681]
[683]
[684]
[686]
[689]
[688]
170
[690]
022.
Roche data stream doubing every 15 months
Paul Hanson
2011 01
021.
What LIMS features are important for labs who use microplates?
Unknown
2011 01
020.
Do you want your LIMS to control your document management

versioning of your SOPS or would you prefer to have it work with third
[692]
party software? What do you prefer to use?
Peggy Weber
2010 12
18
019.
Poll: Would you consider a SaaS (Hosted) LIMS for your Laboratory?
[693]
John Jones
2010 12
17
018.
LiMS forum, the professional network for LIMS, Laboratory, Scientific

[694]
& Health Informatics is now an open group
John Jones
2010 12
017.
Developing or Buying Instrument interfacing application
Zahid Ali
2010 12
016.
Which report design software do you use with your LIMS? How would
[696]
you rate it?
John Jones
2010 11
21
015.
Greetings all, I am looking for a programme for creating a database for

MTB spoligotypes and any software that can help me manage my bio
[697]
banks especially for specimen retreval etc...
Unknown
2010 11
014.
Should Microsoft Break Up?
Phil Morettini
2010 11
013.
LIMS for Pathology Applications
Duncan Carmichael
2010 10
16
012.
Hello, My client is looking for a low cost LIS for Multiple Pathology
[700]
Labs, Can any recommend a proven solution.\ Vijay
Vijay Gupte
2010 10
15
011.
I m just looking for Educational Cds/DVDs for Bachelor Of Science

(BSc) students in subject of CHEMISTRY can any one have an IDEA to
[701]
suggest the best in the market.
Prasad S Rajendra
2010 10
010.
Hospital Processes
Gabriel-Matei Toma
2010 10
009.
I am looking for a LIMS with ERP (Sales/CRM/Biling etc) for companies Vish V.
specializing in calibration and services industry. Majority of the COTS
[703]
software is limited to asset management.
2010 10
008.
Looking for public clouds for scientific workflows
Cui Lin
2010 10
007.
Question: Lab science careers, BS or BA? Lab Science, biotechnology or

biochemistry or molecular biology major? Helping our daughter w/
[705]
college selection.
Scot A. Langdon
2010 10
006.
Vincent Le Texier
Hello Everyone, I am looking for an open-source software or JAVA
packages to search, browse stock samples in a laboratory (eg ; localisation
[706]
of the tubes in a fridge, by shelf, by plate) Thanks
2010 10
005.
What is your understanding of "Collaborating"? Does collaborating work

in a lab or between labs - or was that just and idea which had it's 15
[707]
minutes of fame? How do you collaborate?
Sylvia Ernst
2010 09
004.
Looking for Service and Warranty Management Software
Anurag Kapur
2010 09
[691]
[695]
[698]
[699]
[702]
[704]
[708]
003.
Mini LIMS
002.
001.
[709]
171
Faisal Mirza
2010 09
A manager here thinks that a LIMS administrator is more MIS than a lab
scientist. I think that a scientist should be expert with the labs
[710]
information system, whether paper or electronic. Opinions?
Vaiju (Ujjvala) Bagal
2010 08
21
How does bi-directional information transfer between a lab instrument

[711]
and an LIS work?
Bruce Levkoff
2010 08
References
[1] https:/ / www. linkedin. com/ groups/ Suggestions-simple-sampletracking-software-2069898. S. 5963296841394044932
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[8] https:/ / www. linkedin. com/ groups/ Happy-New-Year-all-I-2069898. S. 5956781863321231362
[9] https:/ / www. linkedin. com/ groups/ Who-could-be-better-partner-2069898. S. 5965838699773124611
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[14] https:/ / www. linkedin. com/ groups/ Which-web-browser-do-you-2069898. S. 5950263958354026498
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[636] http:/ / www. linkedin. com/ groups/ Is-there-anyone-within-our-36640. S. 52709626
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[695] http:/ / www. linkedin. com/ groupItem?view=& gid=2069898& type=member& item=36948886
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Laboratory, Scientific, and Health Informatics

Buyer's Guide
This buyer's guide is based off the LIMS Buyer's Guide, a former
publication of the Laboratory Informatics Institute (LII), an open trade
association associated with LabLynx, Inc. In late 2013, the LII and
LabLynx discontinued publishing a copyrighted version and chose to
release future guides to the public domain via this wiki. Per the
Creative Commons license [1] and the copyright terms of this site, you
are free to copy, adapt, distribute, and transmit this guide as long as
you 1. give proper attribution and 2. distribute the work only under the
same or a similar license.
About this guide

What exactly is a laboratory information management system (LIMS)
or laboratory information system (LIS) anyway? Do I need one? What
options are available and how do I compare them? What about a
request for information (RFI), request for proposal (RFP), or request
for quotation (RFQ)? These are questions laboratory professionals
typically ponder upon finding themselves charged with the mission of finding software for their lab. It can be a
daunting proposition, and there doesn't seem to be any objective reference to help with it all. This guide hopes to
change that.
For this free public domain version of the guide, we've added more vendors, updated new information, and added
links to video demonstrations of their systems, with the goal of providing the accurate information you need to make
decisions for your lab. This guide also strives to be different from any buyer's guide that has ever come before by
including pricing. For the first time you have real information as well as pricing so you can quickly pursue only the
vendors and products that make sense for you and your lab. While in the past vendors have refrained from providing
public pricing, the trend is arguably changing towards a more open information process, though not without its own
set of caveats. In theory, that means prices should decrease as LIMS become commodities that labs can compare and
contrast in a more competitive fashion.
183

At the core all labs are in the business of producing reports, data... essentially information. Everything else is just a
means to that central goal. So in a very real sense, information management is the core of any lab. In a world where
we use the latest technology for most of our daily tasks and pleasures, why do so many labs still rely on hand-written
notes and spreadsheets? Spend thousands of dollars on a sophisticated analytical instrument yet hesitate when faced
with purchasing an information management system? Why? The primary reason is price priorities.
Since LIMS are increasingly becoming commodities, driving down prices, potential buyers don't need to make the
tough decision of one or the other anymore. As technology has improved, smaller LIMS companies have emerged,
along with affordable SaaS online subscription models that are trustworthy. This means any lab can put their
resources where they belong: in information and its management.
Notes about the content

The LIMS Buyers Guide is here to help you wade through the mire. Use the information and vendor profiles to get a
feel for what's out there and what makes the most sense. This guide contains information on everything from "what
is a LIMS?" to maintaining and supporting your system. Additionally, whether you call it a LIMS, LIS, or even a
LMS, in the end it's simply a tool to better manage your lab's data. This guide will refer to it all as LIMS for the
sake of simplicity and consistency, though this guide may include systems officially dubbed as a LIS or ELN.
Finally, a primary criterion for inclusion in this guide is publicly available pricing information that can thusly be
cited. If citeable public pricing is not available, the vendor will not be listed in this guide. Any inappropriate
additions will be removed.
How do I find the right LIMS, and how much will it cost?
OK, LIMS are getting more affordable, but where do you start? You may know the needs of your lab and how it
runs, but perhaps you don't know LIMS and are intimidated by all the options. Take heart! This guide features a
compiled list of major and minor players to help you make initial comparisons. However, you'll first need to gauge
your lab's informatics needs in order to determine which products are worth investigating further. Of course your
lab's analysis requirements, reporting and data sharing constraints, instrument interfacing, barcoding needs, quality
assurance processes, etc. are very important factors. But LIMS vary in numerous ways, and other important factors
exist. Price should certainly be considered, although value is ultimately more important than a low price. Other
important considerations:
Should we purchase licenses or "rent" them via subscription?

Does the software need to be on-site, or is a SaaS hosted option more practical?
Is a modular or complete system better for us?
What is the best licensing/rental scheme for us? Show we consider site, named user, concurrent user, or
workstation licenses?
Is the company qualified and trustworthy?
184
Purchase vs. subscribe

In the past this was not an option. But much like the recent trend toward leasing cars rather than finding a large
amount of money for up-front purchasing, labs can choose to pay only the cost of services (setup, training, report
configuration, instrument interfaces, data migration, custom functions, etc.) and get started on a monthly subscription
rather than buy licenses outright. When does this make sense? Subscriptions make sense primarily:
...if a large lump sum is hard to get budgeted. If your business cash flow will support the regular subscription fee
but finding license fees is more problematic, then a subscription may be right for you. But do the math. Calculate
project costs over a reasonable period (e.g. five years) to make sure it is a value proposition. Be sure to include
maintenance and support in your figures; this is often included in a subscription but not in a license.
...if you may need to reduce the number of users. Once you buy licenses, they are yours. You can't "un-buy" them.
But with a subscription you can raise and lower the number of users, workstations, etc. as you need to.
...if you may need to bail. Business decisions often need to be dynamic. Your lab may decide to go into another
area of analysis, and if your LIMS isn't versatile enough to support the change, you have potentially wasted a lot
of money.
On the other hand, it may be important to you to have the LIMS source code. Some subscriptions allow you just as
much access to it as if you had purchased licenses, while others may not give you the access you seek. Confirm this
with the vendor. Alos, ask whether you get to keep an image of the database should you decide to end your
subscription.
Onsite vs. SaaS

A small but growing number of LIMS vendors will actually host your system on their servers for you or cloud-host it
elsewhere. We refer to software accessed via the Internet rather than your workstation or server as software as a
service or SaaS. Most of us already make copious use of SaaS whenever we "Google" something. Cloudhosted SaaS
is characterized by multiple load-balanced servers that allow resources to be strategically used, and virtualized
servers that allow for the creation of custom environments.To decide if SaaS is for you or if you should go the
traditional route, here are some points to consider:
If you have a small or overworked IT department, or none at all, then it may make sense to let the LIMS provider
take care of those functions rather than invest in additional hardware, personnel, and other resources just to
support your LIMS. If you are a large company with an extensive and capable IT department, then you may prefer
the LIMS and its database to reside on premises.
IT techs cite security as a major reason to keep a LIMS on lab premises. The truth is, if the vendor uses a SAS-70
or SAS 70 Type II data center to host, with GxP SOPs, your system and data are probably a lot safer than on a
typical business infrastructure. Ask the vendor.
If you decide to have your system hosted, ensure it's not by Bob and his buddy in their basement. The vendor
needs to have been around awhile, have solid references, and feature good customer service.
A reputable SaaS host will guarantee you high availability, approaching 100% up time, with quick and responsive
catastrophe response. Redundant components and infrastructure (power, cooling, etc.) allow them to do that.
Modular vs. complete

Some LIMS are offered as a collection of modules for you to select from to constitute your completed system, while
others come complete with all the functionality available. Those whose LIMS are modular espouse the benefit of
only paying for the functionality you need. Those whose LIMS come as a complete package say labs won't need to
pay extra for any add-ons. Who's right? Well, it depends. If buying modules means you need one module for sample
tracking and another for data entry, and still another to generate reports, then it may not be long before you run up a
sizable bill just to get basic standard functionality, especially if the modules require hourly services to implement. If
the modules tend to be industry-specific and complete, then they may make sense. Make sure you compare your
185

needs with the product functionality and identify all costs associated with getting everything you need out of the
software.
Named users vs. concurrent users

When comparing license fees, understand the difference between named users and concurrent users. If a vendor
charges by named users, and your lab will have 30 people who will use the LIMS at any time, you will need 30
licenses. If the vendor charges by concurrent users, then you only need enough licenses to cover the number of users
who are likely to be on the system at the same time. Typically in a lab with 30 staff, you might need a maximum of
20 concurrent user licenses. This is reduced even further if you have sites in other parts of the world whose work
days differ.
The company
As important as the LIMS and its functions are to you, the company is at least as important. Make no mistake: this is
a relationship you are entering into. This is not like selecting a piece of furniture. A LIMS is like a living, dynamic
entity, and you'll need to interact with the vendor from time to time even with the most trouble-free system. Of
course that interaction will be particularly intense in the beginning as they provide installation, provisioning,
training, and other set-up services. Take your cue from your initial dealings with them. Just like in any relationship,
they will be presenting their best side to you then. If the vendor return calls or emails late or fails to follow through
with what they say they'll do, then you can bet it will be much worse once you are their customer. So yes, do the
usual: research their years in business, size, staff qualifications, references, etc., but also ask yourself if you would be
comfortable doing business with the vendor in the long term.
The functionality
And now we come to what probably has weighed most on your mind since you had the first idea you might need a
LIMS: functions and features. The functionality of the LIMS is paramount, so it is important you first have an idea
of what a LIMS can do, and then you can begin to decide which functions and features you need or want.
Core functions and features
You should expect the following functions to be demonstrated in a full-function LIMS:
audit trail
barcoding
batching
chain of custody
configurable setup
data entry
data warehousing and mining
document management
electronic data exchange
data warehousing and mining
event-driven actions
fax and email integration
formulas
instrument interfacing, calibration, and maintenance
inventory
login and accessioning

multiple location/department support
186
regulatory compliance
reporting
review and approval
sample management and tracking
scheduling
training tracking
trending and control charting
version control
workload management
workflow management
Additional useful features

The following functions aren't necessary for all but useful for many:
case management
complaints and corrective actions
customer relationship management
electronic laboratory notebook
ERP and accounting interfaces

invoicing
product specification management
project management
RFID
quoting
safety tracking and compliance
supervisory control and data acquisition (SCADA) interfacing
stability management
web client or portal
How much will it cost?

OK, now you understand what to look for in a company and its products. What you likely don't yet know: the price
tag. Heck, most of us don't even know how LIMS vendors price their products or what is involved, much less how
much they actually cost. In truth, there are three vital pricing components for any LIMS:
1. licenses
2. subscriptions
3. services
The software itself never comprises the entire cost. LIMS are complex creatures, and your lab, even if it's small, is
fairly complex, too. Let's go over what's involved and how much it's roughly going to cost.
Licenses
If the software has a purchased license type (as opposed to rented/subscription), then you will of course have to pay
for those. Keep in mind what we said earlier about named vs. concurrent user pricing. Other methods include by site,
by CPU or server, by workstation, or by unlimited user corporate level licensing. Arguably the lack of
standardization in this area has contributed as much as anything to the vagueness that has surrounded LIMS pricing
for so long. The linked vendor profiles in the next section feature pricing information for licenses for the included
vendors. (Remember: the primary criterion for inclusion is publicly available pricing.) Review and compare, but
make sure you factor in pricing method.
187

Subscriptions
These include two possible items:
1. rented or SaaS LIMS
2. annual maintenance, support, and warranty (MSW)
The cost of LIMS rental is equivalent to the licensed type, but a lump sum up front is not required. These can run
anywhere from a couple of hundred dollars a month for a single user up to maybe $2000 or so for 20+ users. Just like
purchased licenses, however, these can be priced by site, concurrent or named users, etc., so make sure you compare
like with like or at least factor these considerations in as you shop. And your rental may be annual instead of
monthly. In most cases it does include all IT services and maintenance, support, and warranty, including updates, at a
specified level.
The second type of subscription cost is annual MSW, and you need to factor that into your budgeting if you are
buying LIMS licenses. Typically it is priced at around 15 percent of the license fee and is available at graduated
levels. A certain level may be standard for a certain number of licenses (for example, 10 hours of support and
additional services available at $200 per hour for a 10-concurrent user LIMS), but you can buy a higher level of
support and cheaper rate for additional services if you want to pay extra. One thing to keep in mind: with an MSW
you will certainly need coverage as you go through your first year. If you think you can then drop it, think again. A
modern LIMS should be built on technology that can give it a much longer life span than those in years past. That is
dependent on staying updated. If you lose that update path, your LIMS will expire prematurely. If you decide later to
renew MSW, you may find yourself liable for the missed years before the vendor will bring you current.
Services
Your LIMS is a function of the cost of the LIMS itself plus the services involved in its implementation plus, in the
case of a licensed LIMS, annual MSW. Many first-time LIMS buyers neglect to factor in the cost of services when
budgeting. As mentioned earlier, any LIMS will require services to get going, and you may want more if there are
extras you need or want. Services break down more or less like this:
Basic implementation services
kickoff meeting (planning, coordination, communication procedures, etc.)

training
setup (enter users, configure profiles, departments, tests, screens, etc.)
create main report(s)
go live support
Additional or optional services
instrument interfaces
additional reports
data migration from a previous system
interfaces to other systems or databases
special customizations
web portal configuration
validation
standards certification support
You may need other services. Rates for services vary from vendor to vendor, but a good rule of thumb for initial
budgeting purposes is to figure service costs to be roughly equal to the licensing cost or to a year's worth of LIMS
subscription.
188
189
Commercial vendors with public pricing

For free open-source laboratory informatics software, please see the open-source laboratory informatics software page.
Click the link of each vendor to find useful product information, pricing information, and demo videos.
Vendor
Has cloud or
SaaS
offering?
# of
demo
videos
LIMS? LIS? ELN?
LabLynx, Inc.
Yes
36
Yes
No
No
Two Fold Software Limited
No
32
Yes
No
No
BioData Inc.
Yes
28
Yes
No
No
Scilligence Corporation
Yes
23
No
No
Yes
labfolder GmbH
Yes
21
No
No
Yes
LabArchives, LLC
Yes
18
No
No
Yes
Research Innovations Limited
Yes
12
No
No
Yes
Biomatters Ltd.
No
Yes
No
No
eBioSys Pty. Ltd.
No
Yes
No
No
Thermo Scientific
No
Yes
No
No
AgileBio
No
Yes
No
No
Autoscribe Ltd.
No
Yes
No
No
LabVantage Solutions, Inc.
Yes
Yes
No
Yes
Agilent Technologies, Inc.
No
No
No
Yes
Instrumentos Cientficos SA
Yes
Yes
No
No
BiochemLab Solutions
No
No
No
Yes
NoteBookMaker, LLC
Yes
No
No
Yes
Sysment Kft.
No
No
No
Yes
The Edge Software Consultancy

Ltd.
Yes
Yes
No
Yes
LABTrack, LLC
Yes
No
No
Yes
Blaze Systems Corporation
No
Yes
No
No
ChemWare, Inc.
No
Yes
No
No
CloudLIMS.com, LLC
No
Yes
No
No
Dynamic Databases, LLC
No
Yes
No
No
EZQuant Ltd.
No
No
No
Yes
LabWare, Inc.
No
Yes
Yes
No
Laucks Technical Services, LLC
No
Yes
No
No
Promium, LLC
Yes
Yes
No
No
No
Yes
No
Yes
Additional notes
Prices for self-hosted ELN Enterprise edition are not

publicly available.
Pricing only available for non-profit entities; for-profit

prices not public.
Public pricing for Darwin and Galileo unavailable at this

time.
Free ad-based and paid ad-free versions of ELN exist.
LIMS software with additional LIS-like functionality
Pricing only available for LIMS, not ELN.
ChemBytes
190
No
No
No
Yes
FORMULATOR Software, LLC No
No
No
Yes
Margy Tech Pvt. Ltd.
Yes
No
Yes
No
Mountain States Consulting,

LLC
No
Yes
No
No
shazino SAS
Yes
No
No
Yes
SLCLAB Informtica SL
Yes
No
Yes
No
SPLhost, Inc.
Yes
No
No
Yes
Summit Research Services
No
Yes
No
No
System Approach, Ltd.
No
Yes
No
No
TerraSystems
No
No
Yes
No
Additional resources and help

Lab Careers
Lab Careers [2] is a LinkedIn-associated group for the viewing and posting of job openings for laboratory, scientific,
and health lab careers.
LIMS Forum
LIMS Forum [3] is a LinkedIn-associated group for those interested in laboratory, scientific, and health informatics.
LIMS University
LIMS University [4] is a free and open-access learning and teaching resource for those wanting to learn more about
laboratory informatics or LabLynx's ELab system.
LIMSfinder
LIMSfinder [5] is a web portal for those looking for a LIMS and related information, services, products, news,
events, resources, jobs, etc.
LIMSpec
LIMSpec [6] (.zip file) is a collection of templates from lab requirements assessment to LIMS vendor and system
questionnaires, validation documents, and more for identifying LIMS needs and matching them with what's out
there. It's complete with instructions and examples to help guide you through the process.
LIMSwiki informatics resource portal

The informatics resource portal here at LIMSwiki features a collection of as many useful online scientific and health
informatics-related materials and research tools as possible, including books, journals, blogs, web portals, education
programs, conferences, and more.
External links
original LIMS Buyer's Guide page [7]
References
[1]
[2]
[3]
[4]
[5]
[6]
[7]
http:/ / creativecommons. org/ licenses/ by-sa/ 3. 0/

http:/ / www. labcareers. com
http:/ / www. limsforum. com
http:/ / www. limsuniversity. com/
http:/ / www. limsfinder. com/
http:/ / files. limstitute. com/ share/ limstitute/ downloadlimspec. zip
http:/ / limsbook. com/
191
192
8. Key Laboratory Informatics Vendors

LabLynx, Inc.
LabLynx, Inc.
Type
[1]
Incorporated
Industry
Founded
July 24, 2000
Founder(s)
John H. Jones
Headquarters 2400 Lake Park Drive

Suite 435
Smyrna, Georgia 30080,
U.S.
1-866-LABLYNX
Area served
Worldwide
Products
Employees
15
Website
LabLynx.com
[2]
LabLynx, Inc. is a privately owned, funded, and managed American corporation that develops, supports, and
markets laboratory information management system (LIMS) solutions. Its most well-known products include ELab,
a browser-based LIMS, and webLIMS, which is ELab offered in a scalable, hosted "software as a service" (SaaS)
delivery model. The companys primary clients include laboratories in the agriculture, clinical, environmental,
forensics, health care, and manufacturing industries, including government agencies. The company is known for
introducing one of the first browser-based LIMS products in 1997 and being a long-term player in the laboratory
informatics market. Its estimated that LabLynx employs fifteen people.
History
Before LabLynx was a company, it was a LIMS product offered by Atlanta Systems Consultants, Inc. (ASC).
Formed in 1992, ASCs LabLynx division later began work on a laboratory information management system
designed specifically for a web browser. ASC demonstrated its new Internet Explorer-based LabLynx LIMS at
Pittcon in 1997, among the first browser-based LIMS to appear at the time. The company again showcased LabLynx
at Pittcon in 1998 and soon after picked up a major LIMS-based contract with the U.S. Customs Service.
By July 2000, the LabLynx division of ASC separated to become its own incorporated entity. And while ASC
eventually ceased to exist in 2005, LabLynx, Inc. went on to diversify its offerings. LabLynxs browser-based LIMS
previously demonstrated at Pittcon in 1997 expanded to become ELab, which in 2001 took on an application service
provider (ASP) model of distribution. In 2004 LabLynx released a browser-based tool called openLIMS, which gave
consultants and end-users the ability "to build custom LIMS solutions that are geared to the exact operational needs
LabLynx, Inc.
of many different laboratories."
On June 19, 2006, LabLynx established the Laboratory Informatics Institute, an open membership group with the
purpose of advancing the field of laboratory informatics and shaping the standards associated with it. LabLynx made
further moves to better its LIMS offerings in August 2008, renewing and expanding its contract with Nagarro, Inc., a
U.S.-based technology consulting firm. The collaboration allowed LabLynx to upgrade its existing LIMS software to
.NET architecture and expand its initiative to create and market a SaaS-based LIMS. Less than a year after the
announced renewed partnership, LabLynx revealed its redeveloped webLIMS product to the public, featuring ELab
in a SaaS model and additional integration of developer tools to allow users to create and modify modules for the
LIMS. This move to a cloud-based SaaS model brought renewed interest in the companys LIMS, with clients like
the Georgia Department of Agriculture and Cypress Bioscience taking on the new LIMS.
In 2011, LabLynx was involved in an initiative to standardize and structure the transmission of laboratory data that
first originates in a LIMS or LIS and then moves to a person's or population of people's electronic health records.
This laboratory results interface (LRI) pilot began in August 2011 and included collaborations with the supported
open source project mdDigest and the U.S. Office of the National Coordinator for Health Information Technology
(ONC).
Community history
Since transitioning from Atlanta Systems Consultants, Inc. to LabLynx, Inc. in 2000, LabLynx has become
increasingly active in the laboratory informatics community. Projects that LabLynx has started or been involved in
within the community include:
the Laboratory Informatics Institute, an open trade association with the mission of educating, standardizing, and
promoting the laboratory informatics industry
LIMSfinder, an online interactive magazine released by the Laboratory Informatics Institute that aims to be "the
best resource for information technology in the laboratory"
LIMSbook, a LIMS buyers guide released by the Laboratory Informatics Institute
LIMSforum, a LinkedIn discussion group created to facilitate the exchange of ideas and technical information
across the fields of laboratory, science, and health informatics
LIMSuniversity, an open-access learning resource released by the Laboratory Informatics Institute, targeted
towards laboratories and the LIMS community
LIMSwiki, a Creative Commons-licensed wiki with the goal of bringing related informatics communities together
to maintain a repository of information about the industry
Technology and products

LabLynx develops, supports, and markets several products for the laboratory, science, and health industries:
ELab
ELab is a laboratory information management system (LIMS) and collection of associated modules developed to
help professionals in the scientific community manage data coming into and leaving the laboratory. The original
LabLynx LIMS became known as ELab shortly before LabLynx fully separated from Atlanta Systems Consultants,
Inc. in 2001.
Over 30 different modules and functions are included with ELab, and licenses for the software are available with
both onsite of offsite hosting services. LabLynx also states that ELab currently serves in many validated
environments, including 21 CFR Part 11, College of American Pathologists (CAP), and ISO/IEC 17025, in
compliance with such standards as HIPAA, HL7, STORENET, FDA- and EPA-regulated good laboratory practice
(GLP), and more.
193
LabLynx, Inc.
194
webLIMS
webLIMS is a hosted software as a service (SaaS) version of the ELab LIMS. LabLynx introduced the offering in
March 2009, touting 35 different laboratory informatics and business applications in the hosted package. As with
most SaaS software, LabLynx intends to reduce cost to laboratories, decrease the amount of downtime, and provide a
more scalable LIMS solution with its webLIMS service.
LabLynx claims the facility it uses for hosting the webLIMS application is an "SAS70 Type II audited, ultra-safe and
fully redundant data center." To prevent downtime due to power outages, LabLynx states that its data center has:
parallel independent supply lines and facility circuits
instant battery backup and transition to multiple parallel diesel turbine generators
hardware powered by two separate feeds and a Tripp Lite instant power distribution switch to the alternative feed
Product Features
To show the contents of the following section, click the "Expand" link to the right. To later hide the contents for
easier reading, click the "Collapse" link.
The following product features are listed for eLab and webLIMS, as found on the LabLynx site
the features of LabLynx products, consult the feature table below.
[3]
. For more about
1. Sample login, accessioning, etc.

Link documents, tests, processes, and paths to match your workflow.
Create scheduled events.
Create variations for cases, projects/lots, and sample points.
Create sample and result batches.
2. Barcoding
Generate barcode labels and schedule the generation of them.
Track inventory, samples, etc.
3. Mobile device integration and support
4. Workload management
Designate responsibility for any samples, batches or other items based on location, qualification, or other criteria.
View analyst's assignments
5. Workflow management
Set an unlimited number of processes.
Assign specific processes to a specific sample.
6. Scheduling
Define regular intervals for anything, including sample/batch receipt, instrument calibration and maintenance,
training courses, and shelf life.
Schedule holidays and time off.
7. Sample analysis and results entry
Assign sample tests and paths.
Enter results manually or imports them directly from instruments.
View, report, analyze, organize, and export results.
Supports all character types.
Enter comments or attach images.
LabLynx, Inc.
8. QA/QC
Create templates to apply as desired, or create QC samples on an ad-hoc basis.
Support for out-of-limit flagging, formulas, and charting/trending.
9. Instrument interfacing, calibration, and maintenance
Can interface with any instrument that produces a text file.
Track maintenance and calibration history, including any uploaded receipts or other documents.
Store instrument details like model, serial number, date of purchase, assigned tests, authorized analysts, etc.
10. Electronic data exchange
Upload instrument results.
Integrate with third-party software.
Electronically report to systems like eLexnet or other government-mandated protocols.
11. Calculations
Perform numerous calculations, including standard arithmetic, log base 10, exponent, and absolute value.
Includes standard QC-type calcs like "% Recovery of QC Spike," etc.
Results from other tests may be included in calculations.
12. Sample management and tracking
Track the check-in, check-out, transfer, and disposition of samples and other items through the laboratory.
Document location, date/time, and identity of the user performing the actions.
13. Reporting
Use configurable standard or create custom reports using the active reporting tool or database reporting tools.
Print, fax, and e-mail generated reports.
Export to Excel and other formats.
14. Trending and control charting
Export data to Excel for charting of trends.
Use built-in control charting function
15. Audit trails
Modifications made to information are stamped with that users identification and the system level date and time.
Users required to enter a reason for result changes.
Captures the newly entered result as well as the edited result.
Audit trail can be full or targeted.
16. Chain of custody
Support to NELAC/NELAP standards.
Chain of custody reports printable on demand.
17. Document management
Upload and retrieve documents of any kind.
Associate documents with samples, results, personnel, customers, instrument maintenance tracking, etc.
Versioning is forced where required.
18. Inventory
Organize and track any defined items in the LIMS, grouping them according to specific criteria.
195
LabLynx, Inc.
Track storage, usage, and quantity.
Receive alerts when stocks go below a defined level.
19. Training tracking
Track completed courses and certifications for all personnel.
Receive alerts when additional training is required to maintain certifications.
Upload and manage associated documents.
20. Event-driven alerts
Create alert definitions which are triggered according to your requirements.
Trigger events such as sending e-mails based on user-defined criteria.
21. Multi-language support
Configure language settings.
Configure time zone differences for multinational deployment.
22. Compliance
Software complies with ASCLD, NELAC, 21 CFR Part 11, CLIA, GALP/GAMP, HL7, HIPAA, Section 508, ISO
17025, ASTM, IEEE, and ACS standards.
23. Version control
Versioning forced on all relevant changes to system data, including tests, parameters, limits, reports,
configurations, and software.
All changes are date- and time-stamped
24. Configurability
Most aspects of the system can be configured, including database tables, fields, screens, calculations, reports,
charts, external interfaces, tests, parameters, limits.
Define and link processes, tests, and sample or batch paths and all of the associated parameters/limits.
Configure security permissions from micro to macro level on individual screens, tests, processes, job functions,
departments, and laboratory locations.
25. Knowledge management
Archive old data for later queries and data mining.
Warehouse results, reports, trends, e-mails, pricing, invoicing, notes, training, and instrument maintenance tracking
information.
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LabLynx, Inc.
197
LiMStudio
LiMStudio is a virtual desktop add-on to LabLynxs webLIMS hosted application. It consists of a collection of 10
development tools that allow webLIMS users to modify the applications in their account to their own needs. It also
allows users the ability to create their own applications to connect to the LIMS, providing a more scalable and
customizable LIMS option to clients.
The following feature list(s) is/are derived solely from public, freely-available online information the vendor provides. A lack of a
"Y" does not necessarily mean that the product doesn't have that feature. The lack of a "Y" could mean:
the vendor chose to not put relevant feature information online despite its existence in the product.
the vendor chooses to make the feature information available only to those who create an account or call/e-mail.
the feature information exists online to the public, but a URL could not be found to cite the existence of the feature.
the feature does not exist for the product.
A vendor's product may receive more confirmed features with the addition of more public information to the vendor's site and/or by
providing a URL to a page or document that can act as a citation for the existence of the feature. Prospective buyers are highly
recommended to contact the vendor directly to verify features as this list isn't authoritative, and product upgrades and changes happen
rapidly in some cases.
Product: ELab/webLIMS [3]

Sample login and management?
Sample tracking?
Sample and/or result batching?
Task and event scheduling?
Option for manual result entry?
Multiple data viewing methods?
Data and trend analysis?
Data and equipment sharing?
Customizable fields and/or interface?
Query capability?
Import data?
Internal file or data linking?
External file or data linking?
ELN support or integration?
Export data to MS Excel?
Raw data management?
Data warehouse?
Deadline control?
Production control?
Project and/or task management?
Inventory management?
Document creation and/or management?
Case management?
Workflow management?
LabLynx, Inc.
198
Specification management?
Customer and supplier management?
Billing management?
Y
Regulatory compliance?
QA / QC functions?
Performance evaluation?
Audit trail?
Chain of custody?
Configurable roles and security?
Data normalization?
Data validation?
Data encryption?
Version control?
Automatic data backup?
Environmental monitoring?
Y
Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Export to HTML and/or XML?
Fax integration?
Email integration?
Y
Base functionality
Administrator management?
Modular?
Instrument interfacing and management?
Mobile device integration?
Alarms and/or alerts?
Work-related time tracking?
Voice recognition system?
External monitoring?
Messaging?
Multilingual?
Network-capable?
Web client or portal?
LabLynx, Inc.
199
Online or integrated help?
Software as a service delivery model?
Usage-based cost?
Y
Industries served
agriculture, clinical research, environmental, food and beverage, general, law enforcement and forensic, manufacturing and R&D, pharmaceutical,
public health and service
Pricing
ELab/webLIMS
Source for pricing information is via LabLynx. As prices may change at any time, always contact the vendor directly
to obtain a price list or quote.
LIMS Product Price List
Part number
Description
Number of
concurrent users
Price
Unit Price
LLX-ELBS-02
ELab SQL Edition for 2 Concurrent Users
$9,500
$4,750
LLX-ELBS-05
$21,500
$4,300
LLX-ELBS-10
10
$32,000
$3,200
LLX-ELBS-25
25
$75,000
$3,000
LLX-ELBS-50
50
$140,000 $2,800
LLX-ELBS-UL ELab SQL Edition for Unlimited Concurrent Users
Unlimited
$275,000
LLX-ELBO-10
ELab Oracle Edition for 10 Concurrent Users
10
$65,000
LLX-ELBO-25
25
$150,000 $6,000
LLX-ELBO-50
50
$250,000 $5,000
LLX-ELBO-UL ELab Oracle Edition for Unlimited Concurrent Users
Unlimited
$6,500
$475,000
LLX-WLM-02
webLIMS.com (SaaS) Edition for 2 Concurrent Users

(Prices quoted are per month.)
$500
$250
LLX-WLM-05

$800
$160
LLX-WLM-10

10
$1,250
$125
LLX-WLM-25

25
$2,500
$100
LLX-WLM-50

50
$4,000
$80
Unlimited
$7,500
LLX-WLM-UL webLIMS.com (SaaS) Edition for Unlimited Concurrent

Users
LabLynx, Inc.
200
LIMS Maintenance, Warranty, Support, and Service Plans

Maintenance and
support plans
Maintenance
Annual service
and support
hours incl.
Support hours
Maintenance, support, and

service costs
Special notes
Bronze
One year of unlimited

updates and upgrades
plus warranty
8 a.m. to 5 p.m.
EST, excluding
holidays
15% of total license fee;

minimum $4,500 per year;
hourly services and support at
$185/hour
This plan is included at no

charge to all webLIMS
accounts with 19
concurrent users.
Silver

plus warranty
16
8 a.m. to 5 p.m.
EST, excluding
holidays

$175/hour

accounts with 1024
concurrent users.
Gold

plus warranty
24
8 a.m. to 5 p.m.
EST, excluding
holidays

$165/hour

accounts with 2574
concurrent users.
Platinum

plus warranty
40
24 hours per
day, 7 days per
week

$150/hour

accounts with 75+
concurrent users.
Demonstration videos and other media

The following demonstration videos are available for ELab and webLIMS:
LabLynx: A Guide to the Company [4]

LIMS: The Laboratory ERP [5]
LIMS and ISO 17025 [6]
The LabLynx ELab LIMS for Agriculture Labs [7]
The LabLynx ELab LIMS for Water/Wastewater and Environmental Labs [8]
The LabLynx ELab LIMS for Medical Examiners [9]
The LabLynx ELab LIMS for Pharmaceutical Labs [10]
ELab - Key Functions and Topics [11]
ELab: FOG Functionality [12]
ELab: Sample Login and Receiving in ELab [13]
ELab: Sample Receiving In Depth [14]
ELab: Local and Remote Accessioning [15]
ELab: Data Entry - Manual, Bulk, Importing, and Instrument Interfaces [16]
ELab: External Interfaces, Queries, and Exporting Data [17]
ELab: Case Coordination [18]
ELab: Project Receiving [19]
ELab: Benchsheets [20]
ELab: Analysis Price Quoting and Invoicing [21]
ELab: Invoicing - Special Pricing, Editing and Tracking Invoices [22]
ELab: e-Signatures [23]
ELab: Password Management and Session Timeout [24]
ELab: Work Assignment and Tracking [25]
ELab: Inventory of Stocks, Standards, and Reagents [26]
ELab: Creating Storage Locations [27]
LabLynx, Inc.
ELab: Changing Field Captions and Labels [28]

ELab: Instrument Calibration and Maintenance Management [29]
ELab: Creating and Editing Custom Reports [30]
ELab: Tracking and Versioning Reports [31]
ELab: Security Access Control [32]
ELab: Audit Trail [33]
ELab: Results Trending, QC Charting, and Limits Update [34]
ELab: Analyte and Test Group Management [35]
ELab: Creating and Managing Picklists [36]
ELab: System Setup [37]
ELab: Training Management and Certification Tracking [38]
ELab: Forensic Case Management [39]
External links
Official website [2]
Health Cloud Hub website [40]
LIMSuniversity site [4]
LIMSfinder site [5]

LIMSwiki site [41]
LabLynx on Vimeo [42]
LabLynx on YouTube [43]
References
[1] http:/ / en. wikipedia. org/ wiki/ Types_of_business_entity
[2] http:/ / www. lablynx. com/
[3] http:/ / www. lablynx. com/ Products/ ELabLIMS/ tabid/ 240/ Default. aspx
[4] http:/ / files. mylablynx. com/ share/ ebooks/ movies/ p3/ Presentation_Files/ index. html
[5] http:/ / files. mylablynx. com/ share/ eBooks/ Movies/ p4/ Presentation_Files/ index. html
[6] http:/ / files. mylablynx. com/ share/ ebooks/ Movies/ d100/ d100. html
[7] http:/ / www. lablynx. com/ webcasts/ cda/ Presentation_Files/ index. html
[8] http:/ / files. mylablynx. com/ share/ ebooks/ movies/ d7/ d7. html
[9] http:/ / files. mylablynx. com/ share/ ebooks/ movies/ p13/ Presentation_Files/ index. html
[10] http:/ / files. mylablynx. com/ share/ eBooks/ Movies/ p2/ Presentation_Files/ index. html
[11] http:/ / files. mylablynx. com/ share/ ebooks/ Movies/ t4/ t4. html
[20] http:/ / files. mylablynx. com/ share/ eBooks/ Movies/ d14/ d14. html
[29] http:/ / files. mylablynx. com/ share/ eBooks/ Movies/ d24/ d24. html
201
LabLynx, Inc.
[30]
[31]
[32]
[33]
[34]
[35]
[36]
[37]
[38]
[39]
[40]
[41]
[42]
[43]
http:/ / files. mylablynx. com/ share/ ebooks/ movies/ d26/ d26. html
http:/ / files. mylablynx. com/ share/ eBooks/ Movies/ d31/ d31. html
http:/ / files. mylablynx. com/ share/ eBooks/ Movies/ d37/ d37. html
http:/ / files. mylablynx. com/ share/ ebooks/ Movies/ f1/ f1. html
http:/ / www. healthcloudhub. com/
http:/ / www. limswiki. org/
http:/ / vimeo. com/ lablynx
http:/ / www. youtube. com/ user/ lablynx
202
203

Type
[1]
Incorporated
Industry
Headquarters
265 Davidson Avenue

Suite #220
Somerset, New Jersey, U.S.
Number of locations 16
Area served
Worldwide
Products
Website
LabVantage.com
[1]
LabVantage Solutions, Inc. develops and distributes enterprise laboratory informatics software solutions.
History
LabVantage started off as Axiom Systems, which in April 1997 acquired Laboratory MicroSystems from Instron
Corp. and formed a new company LabVantage Solutions. LabVantage made another acquisition later that year,
absorbing Automated Compliance Systems into its portfolio. By 1999 the company had decided to replace or rebrand
most of its products with the "Sapphire" product line, featuring a configurable PC-based client-server architecture. In
the summer of 2011, the company rebranded its Sapphire and SQL*LIMS products to its company namesake.

eNotebook and LabVantage 7
eNotebook is an electronic laboratory notebook (ELN) that "automates and expedites your data entry process and
operations."
LabVantage 7 is a laboratory information management system (LIMS) that "can easily adapt to evolving business
requirements." It can be hosted on your own equipment or hosted in the cloud with LabVantage. The software comes
in several editions:
LabVantage Enterprise, for any enterprise laboratory and industry applications

LabVantage Pharma, a pre-validated solution for the pharmaceutical industry
LabVantage Biobanking, for biorepository management and collection
LabVantage Express, for small labs that don't need much configuration and customization
LabVantage Quality, for "customers across industries looking to go live quickly"
204
Features
Base features of LabVantage 7 include:
information management and tracking for samples, reagents, compounds, specifications, experiments, tasks,
projects, studies, subjects, protocols, etc.
integration with numerous third-party instruments and systems
graphical workflow design and process automation
compliance with government regulations and other standards
For more about the known features of LabVantage 7, see the table below.
Product: eNotebook [2]

Experiment, collaboration,
and data management
Chemical and/or mathematical drawing and calculation?
Chemical and/or spectrum file support?

Configurable templates and forms?
Query capability?
Import data?
Data warehouse?
Lab and/or group management?

Experiment management?
205

QA / QC functions?
Audit trail?
Chain of custody?
Data normalization?
Data validation?
Data encryption?
Electronic signatures?
Version control?
Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Email integration?
Base functionality
Modular?

Third-party software integration?
Messaging?
Bookmarking?
Commenting?
Multilingual?
Network-capable?
206
Usage-based cost?
Industries served
industry-neutral
Product: LabVantage 7 [3]

Sample tracking?

Query capability?
Import data?

Data warehouse?
Deadline control?
Production control?
Document creation and/or management? Y

Case management?
Billing management?
QA / QC functions?
Audit trail?
Chain of custody?
207
Data normalization?
Data validation?
Data encryption?
Version control?
Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Fax integration?
Email integration?
Base functionality
Modular?
Instrument interfacing and management? Y


Messaging?
Multilingual?
Network-capable?

Usage-based cost?
Industries served
industry-neutral
208
Pricing
Source for pricing information is the U.S. General Services Administration
time, always contact the vendor directly to obtain a price list or quote.
[4]
(GSA). As prices may change at any
Note: These are GSA prices, and as such they represent the lowest possible negotiated price. These prices aren't
available to any entity outside of the Federal Government, and thus prices for non-government entities will be
higher. If anything, they represent the lowest possible negotiated price. Pricing for Darwin and Galileo don't appear
to be available at this time.
The GSA prices as of January 2015 all reference the product "SAPPHIRE," which is the old name of "LABVANTAGE 6." Therefore, it is
not clear if these prices apply to the LabVantage 7 product. As always, contact the vendor for specific details on pricing.
Products:
SAPPHIRE concurrent, production environment full user license: $8,795.48
provides role-based browser access to the software for the quantity of users at any given time in a single
application server production environment
SAPPHIRE concurrent, production environment virtual user license: $2,931.83
provides role-based browser access to the software for the quantity of users at any given time to conduct sample
submission, tracking, and view-only reporting of information in a single application server production
environment
SAPPHIRE named, production environment full user license: $4,397.74
provides role-based browser access to the software for the quantity of users by individual name in a single
application server production environment
SAPPHIRE named, production environment virtual user license: $1,465.91
provides role-based browser access to the software for the quantity of users by individual name to conduct sample
submission, tracking, and view-only reporting of information in a single application server production
environment
SAPPHIRE clustered, production environment license: $7,818.20
provides role-based browser access to the software for the quantity of licensed SAPPHIRE users on the quantity
of application servers in a clustered production environment (e.g. per additional application server in the cluster)
SAPPHIRE development environment user license: $9,772.75
provides role-based browser access to the software for the total quantity of licensed SAPPHIRE users at any
given time in a single application server development environment
SAPPHIRE test environment user license: $9,772.75
given time in a single application server test environment
SAPPHIRE training environment user license: $9,772.75
given time in a single application server training environment
SAPPHIRE instrument interface manager: $4,886.38
provides a bundle of fifty (50) SAPPHIRE Object Manager (SOM) licenses for integrating SAPPHIRE to
third-party systems and instruments
SAPPHIRE concurrent, ad hoc query tool: $977.28
provides role-based browser access to this tool for the quantity of users at any given time
SAPPHIRE named, ad hoc query tool: $488.64

provides role-based browser access to this tool for the quantity of users by individual name
SAPPHIRE advanced storage and logistics module: $87,954.75
provides role-based browser access to this module for the total quantity of licensed SAPPHIRE users
SAPPHIRE bio-banking module: $146,591.25
provides role-based browser access to this module, along with the advanced storage and logistics module, for the
total quantity of licensed SAPPHIRE users
SAPPHIRE scheduler module: $4,886.38
SAPPHIRE stability module: $29,318.25
SAPPHIRE CAPA module: $19,545.50
SAPPHIRE Enterprise Connector: $29,318.25
enables the exchange of information between the mySAP ERP application and the SAPPHIRE Software using
SAP NetWeaver Exchange Infrastructure
SAPPHIRE Installation Qualification: $4,886.38
provides documentation and test scripts for qualifying the installation of the out-of-the-box version of the licensed
SAPPHIRE software, excluding modules
SAPPHIRE Operational Qualification: $9,772.75
provides documentation and test scripts for qualifying the operation of the out-of-the-box version of the licensed
SAPPHIRE software, excluding modules
SAPPHIRE Evergreen Studio Web Page Designer, Professional Edition: $19,545.50
provides a bundle of ten (10) "developer" user licenses, usable at any given time, enabling users to create new
configured pages in the software in addition to the functionality of the Standard Edition
Services:
First Annual Maintenance & Support Services: 18% of GSA discounted net software cost
maintenance and support beginning after expiration of the 90-day warranty period and ending one (1) year
thereafter
Introduction to SAPPHIRE course: $2,052.28/student
three-day course, with optional certification exam, introduces the student to the components of SAPPHIRE and
allows them to work in the out-of-the-box version of the software
The following informational videos are available for LabVantage Solutions software products:
It's official... LABVANTAGE 6 has been released! [5]

LABVANTAGE Monza training facility grand opening [6]
LABVANTAGE and the cloud [7]
LABVANTAGE Connect [8]
LABVANTAGE DMS and iterative development [9]
LABVANTAGE virtual training [10]
209

Additional information
LabVantage LIMS brochure [11]
References
[1] http:/ / www. labvantage. com/
[2] http:/ / www. labvantage. com/ solutions/ technology/ enotebook. aspx
[3] http:/ / www. labvantage. com/ lims/ index. aspx
[4] https:/ / www. gsaadvantage. gov/
[5] http:/ / www. youtube. com/ watch?v=Yt5OoAdG2mA
[6] http:/ / www. youtube. com/ watch?v=fiMuGTpbQ-Q
[7] http:/ / www. youtube. com/ watch?v=SEFL2njP2Ng
[8] http:/ / www. youtube. com/ watch?v=vM0GpO5FjZ0
[9] http:/ / www. youtube. com/ watch?v=-rOPAXC3Uz0
[10] http:/ / www. youtube. com/ watch?v=IMpYqacfziY
[11] http:/ / www. labvantage. com/ resources/ pdf/ brochures/ LABVANTAGE1204AL04CYL. pdf
210
LabWare, Inc.
211
LabWare, Inc.
LabWare, Inc.
Type
[1]
Incorporated
Industry
Headquarters
Three Mill Road

Suite 102
Wilmington, Delaware, U.S.
Number of locations 24
Area served
Worldwide
Products
Website
LabWare.com
[1]
LabWare, Inc. develops and distributes enterprise laboratory informatics software solutions.
History
LabWare was founded in 1987 by mechanical engineer and entrepreneur Vance Kershner, who "targeted the
laboratory automation space as something [he] could contribute to because it was not very effective at the time."
By 2013, the company estimated it had captured close to a quarter of worldwide sales of laboratory information
management systems.
Awards
LabWare won the Scientific Computing and Instrumentation's Readers' Choice Award in the laboratory information
management mystem (LIMS) category each year from 2000 to 2008.
LabWare LIMS won a Frost & Sullivan Product Quality Leadership Award in 2004, and the company won Frost and
Sullivan's "2008 European Laboratory Information Management Systems (LIMS) Company of the Year Award."

LabWare ELN and LabWare LIMS
LabWare ELN is an electronic laboratory notebook (ELN) "designed to give laboratory scientists the ultimate
platform to electronically document their experiments, including relevant scientific content and observations,
instrument results, and attachments such as spectra, chromatograms and, if appropriate, chemical structures."
LabWare LIMS is a laboratory information management system (LIMS) which includes "browser-based deployment,
external-facing web portals, and fully configurable web services." The software consists of the core LIMS
application with access to LabWare's library of LIMS software modules. The software also includes clinical,
LIS-like functionality.
LabWare, Inc.
212
Features
Product: LabWare ELN [2]

and data management
Chemical and/or mathematical drawing and calculation?

Query capability?
Import data?

Data warehouse?

QA / QC functions?
LabWare, Inc.
213
Audit trail?
Chain of custody?
Data normalization?
Data validation?
Data encryption?
Version control?

Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Email integration?
Y
Base functionality
Modular?

Messaging?
Bookmarking?
Commenting?
Multilingual?
Network-capable?
Usage-based cost?
Industries served
biotechnology, chemical, clinical research, environmental, food and beverage, general, manufacturing and R&D, petrochemical, pharmaceutical
Product: LabWare LIMS [3]
LabWare, Inc.
214

Sample tracking?

Query capability?
Import data?

Data warehouse?
Deadline control?
Production control?
Case management?
Billing management?
QA / QC functions?
Audit trail?
Chain of custody?
Data normalization?
Data validation?
Data encryption?
Version control?
LabWare, Inc.
215

Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Fax integration?
Email integration?
Y
Base functionality
Modular?

Messaging?
Multilingual?
Network-capable?

Usage-based cost?
Industries served
biotechnology, chemical, clinical research, environmental, food and beverage, general, geology and mining, health care, manufacturing and R&D,
petrochemical, pharmaceutical, power and utility, veterinary
Pricing
Source for pricing information is GSA Advantage [4]. As prices may change at any time, always contact the vendor
directly to obtain a price list or quote.
Note: These are U.S. General Services Administration [4] (GSA) prices, and as such they represent the lowest
possible negotiated price. These prices aren't available to any entity outside of the Federal Government, and thus
prices for non-government entities will be higher. If anything, they represent the lowest possible negotiated price.
LabWare, Inc.
216
LabWare LIMS Version 6 Price List

Part number
2100.60
Description
Price
LabWare LIMS Version 6 license $6,900
LabWare's GSA price list [5]

The following demonstration videos are available for LabWare LIMS:
LabWare at Pittcon2011 [6]
LabWare LIMS V6 Technical Manual [7]
References
[1]
[2]
[3]
[4]
[5]
[6]
[7]
http:/ / www. labware. com/ en

http:/ / www. labware. com/ en/ p/ Products/ ELN-%28Electronic-Laboratory-Notebook%29
http:/ / www. labware. com/ en/ p/ 04
https:/ / www. gsaadvantage. gov/ advantage/ catalog/ product_detail. do?oid=391496981& itemIndex=-1
https:/ / www. gsaadvantage. gov/ ref_text/ GS07F5446R/ GS07F5446R_online. htm
http:/ / www. youtube. com/ watch?v=4--HjpwGj_c
http:/ / limshelp. labware. com/ limsv6/ V6Help_Main. htm
217
Type
[1]
Industry
Corporation
Headquarters Presidential Building

4000 Hollywood
Boulevard
Suite 333 South
Hollywood, Florida, U.S.
Area served
Worldwide
Products
Parent
Abbott Laboratories
Website
STARLIMS.com
[1]
STARLIMS Corporation develops and distributes laboratory informatics software solutions.
History
STARLIMS Technologies Ltd. was founded by Itschak Friedman and incorporated under the laws of the State of
Israel in May 1986. In November 1993, STARLIMS completed an initial public offering of its ordinary shares,
which have traded on the Tel Aviv Stock Exchange since. The company made a public offering in the United States
in May 2007 and was introduced to the NASDAQ under the Stock Market under the symbol LIMS.
In August 2008, the Company announced the establishment of STARLIMS Europe as a result of the May 2008
acquisition of its United Kingdom partner Lab Data Management Ltd., based in Bolton, Greater Manchester.
In late 2009 it was revealed Abbott Laboratories would acquire all outstanding equity of STARLIMS
Technologies.The deal was finalized on March 22, 2010 for a published cost of $123 million.
218

STARLIMS and STARLIMS Electronic Laboratory Notebook
STARLIMS is a web-based laboratory information management system (LIMS) "designed to help you meet all your
information management objectives." The LIMS is also available as a SaaS offering as "STARLIMS Cloud
Services."
STARLIMS Electronic Laboratory Notebook is an ELN that "[ensures] regulatory compliance and data integrity by
eliminating paper-based notebooks."
Features
Product: STARLIMS [2]

Sample tracking?


Query capability?
Import data?
Data warehouse?
Deadline control?
Production control?
219
Case management?
Billing management?
Y
QA / QC functions?
Audit trail?
Chain of custody?
Data normalization?
Data validation?
Data encryption?
Version control?

Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Fax integration?
Email integration?
Y
Base functionality
Modular?

220
Messaging?
Multilingual?
Network-capable?
Usage-based cost?
Industries served
chemical, contract services, cosmetic, environmental, food and beverage, general, law enforcement and forensic, manufacturing and R&D,
petrochemical, pharmaceutical, power and utility, public health and service
Product: STARLIMS Electronic

Laboratory Notebook [3]
and data management
Chemical and/or mathematical drawing and calculation? Y

Query capability?
Import data?
Data warehouse?

221
QA / QC functions?
Audit trail?
Chain of custody?
Data normalization?
Data validation?
Data encryption?
Version control?
Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Email integration?
Base functionality
Modular?

Messaging?
Bookmarking?
Commenting?
Multilingual?
Network-capable?
Usage-based cost?
Industries served
industry-neutral
222
Pricing
Source for pricing information is GSA Avantage
directly to obtain a price list or quote.
[4]
. As prices may change at any time, always contact the vendor
Note: These are U.S. General Services Administration [4] (GSA) prices, and as such they represent the lowest
possible negotiated price. These prices aren't available to any entity outside of the Federal Government, and thus
prices for non-government entities will be higher. If anything, they represent the lowest possible negotiated price.
Products:
STARLIMS v10 concurrent full user license: $8,160.75
provides an individual user full access to all STARLIMS functions and wizards at the same time as a permitted
number of other users in the customer's organization
STARLIMS v10 concurrent data user license: $2,720.25
allows an individual lab data consumer to view analytical services provided by the lab, view sample status, and
print COAs or invoices at the same time as the permitted number of other users in the customer's organization
STARLIMS for SAP v10 site license: $18,135.00
allows a lab site use of the STARLIMS for SAP interface, which has been certified by SAP AG for the
component SAP R/3 Enterprise 4.6; Note: The certification of the interface between STARLIMS and SAP
confirms the existence of product functionality in accordance with SAP's certification procedure.
STARLIMS Stability Studies v10 site license: $27,202.50
allows a lab site to create and maintain stability studies within the lab's workflow
STARLIMS XFD Designer license: $19,142.50
allows authorized users to intuitively configure and make appropriate enhancements and modifications as
business requirements change
STARLIMS for Waters Empower v10 license: $13.601.25
acts as an interface between the Waters Empower chromatography data system and STARLIMS, enabling
bi-directional information flow with the CDS without intervening steps
STARLIMS Scientific Document Management System site license: $54,405.00
this STARLIMS-integrated SDMS provides scientists of a lab site with the capability to automatically capture and
parse relevant instrument data files and documents, transform unstructured data into XML, and extract key words
or other metadata
Services:
STARLIMS v10 annual support plan: $2,720.25
provides unlimited telephone, FAX, modem, e-mail, and website operational support during normal business days
STARLIMS v10 per diem off-site LIMS consultant services: $1,269.45
provides eight hours of STARLIMS analyst/trainer/developer off-site training and analysis
STARLIMS v10 per diem on-site LIMS consultant services: $1,360.13
provides eight hours of STARLIMS analyst/trainer/developer on-site training and analysis
STARLIMS for SAP v10 annual update package program: $2,538.90
provides program updates, fixes, corrections, workarounds, releases, versions, and enhancements as well as
documentation updates that are issued by STARLIMS Corporation for the STARLIMS for SAP software, all
during the period the customer contracts for support service
STARLIMS for Waters Empower v10 annual update package program: $1,904.18
provides program updates, fixes, corrections, workarounds, releases, versions, and enhancements as well as
documentation updates that are issued by STARLIMS Corporation for the STARLIMS for Waters Empower
software, all during the period the customer contracts for support service
The following demonstration videos are available for STARLIMS:
STARLIMS Corporation, An Abbott Company, at Pittcon2011 [5]
STARLIMS brochure [6]
STARLIMS ELN brochure [7]
References
[1]
[2]
[3]
[4]
[5]
http:/ / www. starlims. com/

http:/ / www. starlims. com/ solutions/ lims/
http:/ / www. starlims. com/ solutions/ electronic-laboratory-notebook/
https:/ / www. gsaadvantage. gov/ ref_text/ GS35F0660P/ 0M5NNM. 2P92E1_GS-35F-0660P_GS35F0660P. PDF
http:/ / www. youtube. com/ watch?v=Vu7z72OF_wE
[6] http:/ / www. starlims. com/ support-and-resources/ resources/ starlims-v10-brochure/

[7] http:/ / www. starlims. com/ en-us/ services-and-resources/ resources/ electronic-notebook-brochure/
223
Thermo Scientific
224
Thermo Scientific
Thermo Scientific
Industry
Scientific hardware/software
Headquarters
81 Wyman Street
Waltham, Massachusetts, U.S.
Number of locations 85+

Area served
Worldwide
Products
Parent
Thermo Fisher Scientific, Inc.
Website
ThermoScientific.com
[1]
Thermo Scientific develops and distributes scientific hardware and software solutions.
History
Some of Thermo Scientific's existing products are acquisitions, originating from the purchase of InnaPhase
Corporation in 2004.
On May 14, 2006, Thermo Electron and Fisher Scientific announced that they would merge in a tax-free,
stock-for-stock exchange, with the merged company being named Thermo Fisher Scientific; the merger was
announced completed on November 9. However, the Federal Trade Commission (FTC) ruled that this acquisition
was anti-competitive with regard to centrifugal vacuum evaporators (CVEs) because "Thermo and Fisher are the
only two significant suppliers of high-performance CVEs in the United States." The FTC required Fisher to divest
Genevac to settle the charges of anti-competitive behavior. In April 2007, Genevac was sold to Riverlake Partners,
LLC, and the divestiture met FTC approval in March 2007.
Currently, Thermo Scientific is one of the brand names used by Thermo Fisher Scientific. Other brand names used
over the years have included Fisher Scientific, Chromacol, Nalgene, Cellomics, Cole-Parmer, Pierce Protein
Research, and Fermentas.

Software
Thermo Fisher develops, supports, and markets many software products for the laboratory, science, and health
industries:
Darwin is a pharmaceutical-based laboratory information management system (LIMS) designed with "purpose-built
functionality to align directly with manufacturing processes and give managers the information needed to make
cost-effective decisions while still ensuring product safety and regulatory compliance."
Galileo is a scalable, purpose-built LIMS "developed to improve screening, increase throughput, and lower testing
costs" for ADME/Tox labs.
Thermo Scientific
225
Nautilus is a general-purpose LIMS "that increases workflow efficiency, throughput and data reliability while
simplifying administration, sample traceability and regulatory compliance."
SampleManager is an industry-neutral LIMS that "increases productivity and improves the responsiveness and
agility of labs across a wide range of regulated and non-regulated industries."
Watson is LIMS for bioanalytical labs that "facilitates efficient study design and data transfer while streamlining
assay validation, bioanalysis, instrument interfacing, sample tracking, results reporting and regulatory compliance."
Features
Product: Darwin
[2]
Sample, Inventory, and Data Management

Sample tracking?

Query capability?
Import data?
Export raw date?
Data warehouse?
Deadline control?
Production control?
Thermo Scientific
226
Case management?
Customer management?
Billing management?
Quality, Security, and Compliance
QA / QC functions?
Audit trail?
Chain of custody?
Data normalization?
Data validation?
Data encryption?
Version control?

Reporting, Labeling, and Printing

Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Fax integration?
Email integration?
Base Functionality
Modular?
Messaging?
Multilingual?
Thermo Scientific
227
Network-capable?
SaaS delivery option?
Usage-based cost?
Industries Served
clinical research, manufacturing and R&D,
pharmaceutical
Product: Galileo
[3]

Sample tracking?

Query capability?
Import data?
Export raw date?
Data warehouse?
Deadline control?
Production control?
Case management?
Billing management?
Thermo Scientific
228
QA / QC functions?
Audit trail?
Chain of custody?
Data normalization?
Data validation?
Data encryption?
Version control?
Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Fax integration?
Email integration?
Base Functionality
Modular?

Messaging?
Multilingual?
Network-capable?
Usage-based cost?
Industries Served
biotechnology, life sciences
Thermo Scientific
229
Product: Nautilus
[4]

Sample tracking?


Query capability?
Import data?

Export raw date?
Data warehouse?
Deadline control?
Production control?
Case management?
Billing management?
QA / QC functions?
Audit trail?
Chain of custody?
Data normalization?
Data validation?
Data encryption?
Thermo Scientific
230
Version control?
Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Fax integration?
Email integration?
Base Functionality
Modular?
Messaging?
Multilingual?
Network-capable?

Usage-based cost?
Industries Served
general, manufacturing and R&D, pharmaceutical
Thermo Scientific
231
Product: SampleManager
[5]

Sample tracking?


Query capability?
Import data?
Export raw date?
Data warehouse?
Deadline control?
Production control?


Case management?
Billing management?
QA / QC functions?
Audit trail?
Chain of custody?

Data normalization?
Data validation?
Data encryption?
Thermo Scientific
232
Version control?

Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Fax integration?
Email integration?
Y
Base Functionality
Modular?


Messaging?
Multilingual?
Network-capable?

Usage-based cost?
Industries Served
industry-neutral
Thermo Scientific
233
Product: Watson
[6]

Sample tracking?


Query capability?
Import data?

Export raw date?
Data warehouse?
Deadline control?
Production control?
Case management?
Billing management?
QA / QC functions?
Audit trail?
Chain of custody?
Data normalization?
Data validation?
Data encryption?
Thermo Scientific
234
Version control?
Custom reporting?
Report printing?
Label support?
Barcode support?
Export to PDF?
Export to MS Word?
Fax integration?
Email integration?
Base Functionality
Modular?
Messaging?
Multilingual?
Network-capable?
Usage-based cost?
Industries Served
biotechnology, clinical research, contract services,
life sciences, pharmaceutical
Pricing
Source for pricing information is the U.S. General Services Administration
time, always contact the vendor directly to obtain a price list or quote.
[4]
(GSA). As prices may change at any
Note: These are GSA prices, and as such they represent the lowest possible negotiated price. These prices aren't
available to any entity outside of the Federal Government, and thus prices for non-government entities will be
higher. If anything, they represent the lowest possible negotiated price. Pricing for Darwin and Galileo don't appear
to be available at this time.
Thermo Scientific
Nautilus 5 concurrent user license with Integration Manager base system: $43,841.44
Includes five concurrent user licenses for Nautilus client server LIMS, one Integration Manager Server LIMS
instance connection license, and three instrument connection licenses
Nautilus 5 additional concurrent user license: $7,314.66 each
Additional concurrent user license to be added to Nautilus base system (INF-12005G)
SampleManager 5 concurrent user license with Integration Manager base system: $42,086.77
Includes one Integration Manager Server LIMS instance connection license and three instrument connection
licenses
SampleManager 5 additional concurrent use license: $7,014.46 each
Additional concurrent user license to be added to SampleManager base system (INF-11005G)
Watson concurrent user license with Designer base system: $105,216.91
Includes five concurrent user licenses for Watson LIMS, one Designer Server license, and five Designer user
licenses
The following demonstration videos are available for Thermo Fisher software products:
Laboratory Information Management Systems: Darwin [7]

Laboratory Information Management Systems: Nautilus [8]
Laboratory Information Management Systems: SampleManager [9]
Laboratory Information Management Systems: Watson [10]
Integration Manager: Paperless Laboratory Workflow [11]
A Water and Environmental Testing Configuration of SampleManager [12]
SampleManager 11: Most Configurable LIMS, SampleManager 11 [13]
SampleManager 11: SampleManager 11, with Configurable Data Flow-Through [14]
SampleManager 11: Automated Regulatory Compliance Workflows for Food Production [15]
References
[1] https:/ / www. thermoscientific. com/
[2] http:/ / www. thermoscientific. com/ en/ product/ darwin-lims-pharmaceutical-manufacturing-r-d-qaqc-labs. html
[3] http:/ / www. thermoscientific. com/ en/ product/ galileo-lims-hts-adme-laboratories. html
[4] http:/ / www. thermoscientific. com/ en/ product/ nautilus-lims-dynamic-discovery-r-d-environments. html
[5] http:/ / www. thermoscientific. com/ en/ product/ samplemanager-lims. html
[6] http:/ / www. thermoscientific. com/ en/ product/ watson-lims-bioanalytical-laboratories. html
[7] https:/ / www. youtube. com/ watch?v=J7ObCBV3dBg
[8] https:/ / www. youtube. com/ watch?v=NA6uTPWM4-4
[9] https:/ / www. youtube. com/ watch?v=x4jp6TooGDE
[10] http:/ / demos. thermoinformatics. com/ watson_en. htm
[11] https:/ / www. youtube. com/ watch?v=1hlHcyyyNKw
[12] https:/ / www. youtube. com/ watch?v=g3RMfNgsrek
[13] https:/ / www. youtube. com/ watch?v=grHBr1WEYuA
[14] https:/ / www. youtube. com/ watch?v=0-rHz8nDn5w
[15] https:/ / www. youtube. com/ watch?v=dv_18I6imoc
235
236
9. Laboratory Informatics Vendor Directory

LIMS vendor
Looking for clinical- or hospital-based informatics systems? You may want to also check out the LIS vendor page.
Before adding a specific vendor or product to LIMSwiki, please review the LIMSWiki:Vendor page and LIMSWiki:Product page articles
respectively.
They explain the general guidelines that should be followed when creating such pages.
A LIMS vendor is an entity (business, company, corporation, etc.) which provides laboratory information
management system (LIMS) software or software packages. The LIMS software may be very generalized to handle a
great number of laboratory situations, or it may be very specific to handle the needs of a certain field of study. Of
course, every LIMS may have a different feature set based upon its intended focus.
Active LIMS vendors

To find LIMS vendors by the industry or industries they serve, please see the categorical organization tool LIMS vendors by industry.
Note: The columns of this table are sortable for your convenience. Simply click the small arrows in the
title of each column to use this feature. Additionally, if you wish to sort by column X and then column
Y, simply left-click the desired arrow for the first column to sort by, and then hold the Shift key and
left-click the desired arrow for the second column to sort by.
Vendor
Key LIMS offering(s)
Headquarters
(Country)
10BioSystems, LLC
LabCentral
United States
2nd Sight Solutions
OhNo!
Canada
3rd Millennium, Inc.
ARDAS
United States
AAC Infotray AG
Limsophy LIMS
Switzerland
ABB Ltd.
ABB LIMS
United States
Adifo NV
BESTMIX LIMS
Belgium
Advanced Business Software
PHIMS
United States
Advanced Technical Software
uniLIME
Austria
Advanced Technology Corp.
VADDS, VETSTAR
United States
Agaram Technologies Pvt. Ltd.
QuaLIS
India
AgiLab SAS
AgiLIMS
France
AgileBio
LabCollector
United States
LimsLink
United States
Additional notes
Former product Laboras now seems

defunct.
Former product q/LIME seems no longer

supported.
LIMS vendor
237
AJ Blomesystem GmbH
LABbase, readyLIMS
Germany
Alcor SPRL
CI-Master, LabTec
Belgium
Alpha Technologies US, LP
ECLIPSE, Enterprise ULTIMA
United States
Ambidata Digital Innovation Solutions &

Consulting, Lda.
LabWay-LIMS
Portugal
Analytical Information Systems, Ltd.
AIS LIMS
United Kingdom
arivis AG
scarabLIMS
Germany
ASM Soft SL
ASM-LIMS
Spain
Assaynet Inc.
LIMS2010, LIMS.net
Canada
Asystance V.O.F.
Alis LIMS
Netherlands
ATGC Labs, LLC
ActiveLIMS
United States
Aurora Systems, Inc.
VisuaLab
United States
Autoscribe Ltd.
Matrix Gemini
United Kingdom
BARTELT GmbH
datalabX
Austria
Baytek International, Inc.
MicroBLISS, WebBLISS, WebSQC, United States

WinBLISS
Baze Technology AS
BazeLab LIMS
Norway
Beijing Teleh Electronic Tech Co., Ltd.
Bio-2000, TL LAB2000
China
BGASoft, Inc.
LIMS ABC
United States
Bika Lab Systems (Pty) Ltd.
Bika LIMS
South Africa
Bio-Analytical Technologies Pvt. Ltd.
BioClinical
India
Bio-ITech BV
eLabJournal
Netherlands
BioData Inc.
Labguru
United States
Biomatters Ltd.
Geneious
New Zealand
BioTeam Inc.
MiniLIMS
United States
Blaze Systems Corporation
BlazeLIMS
United States
Bode Technology Group, Inc.
BodeLIMS
United States
FIVAS, LABcua, and LABpharma

appear to no longer be offered as of
2013.
New readyLIMS appeared in 2012.
Previous name for LIMS2010 was

LIMS2003.
North American distributor/support team

was Zumatrix, Inc.
until it was absorbed into new entity
Autoscribe Informatics Inc.
Also available at SourceForge.net

under GPL.
[1]
Labguru replaced LabLife and BioKM

on December 5, 2011.
LIMS vendor
238
Broughton Software Ltd.
LabHQ
United Kingdom
Bruker Corporation
SampleTrack
United States
BTLIMS Technologies
BTLIMS
United States
Bytewize AB
O3 LIMS, O3 LIMSXpress
Sweden
Caliber Technologies Pvt. Ltd.
CaliberLIMS, Caliber Pet-LIMS
India
Camin Cargo Control, Inc.
POLARIS
United States
Cargotrader, Inc.
Cargotester.com
United States
ChemWare, Inc.
HORIZON Central
United States
ChikPea, Inc.
ChikPea LIMS
United States
Chromasoft GmbH
Lab21 LIMS
Germany
Cimarron Software, Inc.
SDK
United States
Civil Systems, Inc.
CSi LIMS
United States
Clinical Systems Ltd.
ClinAxys II
United Kingdom
CliniSys
WinPath Enterprise
United Kingdom
CliniSys Group Limited
See vendors CliniSys and MIPS
United Kingdom
CloudLIMS.com, LLC
BioTracer
United States
Clyde Computing Ltd.
Q-SYS LIMS
United Kingdom
Codon Software Private Limited
Codon LIMS
India
Columbia Energy & Environmental Services,

Inc.
OmniLIMS
United States
Common Cents Systems, Inc.
ApolloLIMS
United States
CompuDrug International, Inc.
Laboratory Manager Plus
United States
Computer Aid, Inc.
HealthLIMS
United States
Computer Sciences Corporation
CSC LIMS
United States
Computing Solutions, Inc.
LabSoft LIMS
United States
Condition Monitoring International, LLC
LabTrak
United States
Contec Group International Ltd.
MADCAP
New Zealand
Core Informatics, LLC
Core LIMS
United States
Cosine Consultants Ltd.
Fission LIMS
Cyprus
CSS LIMS GmbH
iLIMS
Germany
Was formerly SkySource Ltd.
Caliber Pet-LIMS was previously

Caliber Petro-LIMS.
Cimarron creates custom LIMS solutions

using a source development kit.
Formerly marketed Cirrus and M/LAB

as preceding products
Changed company and product name in

January 2014.
LIMS vendor
239
Dassault Systmes SA
Accelrys LIMS
France
Data Unlimited International, Inc.
Starfruit CrimeLab, Starfruit DNA,

Starfruit GeneTell, Starfruit
IdentiTrack,
Starfruit Toxicology
United States
Dataworks Development, Inc.
Freezerworks
United States
Desert Oasis Software Company, LLC
ALIS
United States
dialog EDV Systementwicklung GmbH
diaLIMS
Germany
DIPOLE SARL
DipLABO
France
Dynamic Databases, LLC
limsExpress
United States
e-BiOnary Technologies Ltd.
e-BiOData
India
eBioSys Pty. Ltd.
eLab
Australia
ElmTree Systems, LLC
ElmTree System
United States
entimo AG
PhaLIMS
Germany
EthoSoft, Inc.
X-LIMS
United States
Eusoft Srl
EuSoft.Lab
Italy
Finalist Software Noord Nederland C.V.
FinaLims
Netherlands
Forensic Advantage Systems
Forensic Advantage
United States
Frontier Science & Technology Research

Foundation, Inc.
LDMS
United States
Future Technologies, Inc.
DNA LIMS
United States
Genee Group, LLC
LabScout LIMS
United States
Genesis MicroSystems, Inc.
LAB-2000
United States
Genial Genetic Solutions, Ltd.
iGene, Shire
United Kingdom
Genohm BVBA
SLims
Belgium,
Switzerland
GenoLogics Life Sciences Software Inc.
Clarity LIMS
Canada
GoInformatics, Inc.
GoLIMS
United States
GyroDimensions, Inc.
BioInfoStream
United States
H&A Scientific, Inc.
IntelliLIMS, SLIM
United States
Hach Company
Hach WIMS
United States,
Germany
Hamsoo IT Consultants Co.
PetroLab
Iran
HiTec Zang GmbH
HiLIMS
Germany
HM-Software
HM-LIMS
Germany
Dassault acquired Accelrys, Inc. on April

29, 2014.
A division of TCSC, Inc.
Geneus, Omix, and Proteus seem to have

been phased out in 2011.
GenoLogics LIMS was phased out in
2012, replaced by Clarity LIMS.
LIMS vendor
240
IBS AG
CAQ=QSYS LIMS
Germany
ICD. GmbH
LABS/Q, LABS/QM, LABS/R
Germany
iLab Solutions, LLC
Core Facility Management, Lab

Management
United States
Illumina, Inc.
Illumina LIMS
United States
In Siliflo, Inc.
In Siliflo LIMS
United States
Indusoft OOO
I-LDS LIMS
Russia
Inflection Point Solutions, LLC
PIMS
United States
Infomed C.S.
Lab@link
Greece
Information Management Services, Inc.
BSI, SEER*DMS
United States
InfoTrak Pty. Ltd.
InfoTrak Oil
Australia
Instem LSS Limited
Centrus, Provantis
United Kingdom
Instrumentos Cientficos SA
NevisLIMS
Spain
Integromics SL
OmicsHub, OmicsOffice
Spain
Interface Engineering Co. Ltd.
Nova-LIMS
South Korea
Interpec Corporation
INQAS, INTRACES
United States
InterSystems Corporation
TrakCare Lab
United States
ISP Technologies SA
Labmin
South Africa
Jova Solutions Inc.
FermWorks
United States
JusticeTrax, Inc.
LIMS-plus
United States
jwConsulting GmbH
jwLIMS
Germany
Kenny Agrisoft Ltd.
DairyLIMS
Ireland
Khemia Software, Inc.
Omega 11 LIMS
United States
Kriti Microsystems Pvt. Ltd.
Kriti LIMS
India
Labage SA
benchsys
Belgium
LabCloud, Inc.
LabCloud
United States
LabKey Corporation
LabKey Server
United States
LabLite, LLC
LabLite SQL LIMS
United States
LabLogic Systems Limited
Debra 5, PETra, Sara 5
United Kingdom
LabLynx, Inc.
ELab, webLIMS
United States
Previous product name was Oil

Commander.
Former product was called ArrayHub

(now defunct)
LIMS vendor
241
LabPro 2000 Ltd.
LabPro, eQual
New Zealand
Labsoft Tecnologia Ltda.
myLIMS
Brazil
LabTech, Inc.
Kuiper-LIMS
United States
LabVantage 7
United States
LabWare, Inc.
LabWare LIMS
United States
Laucks Technical Services, LLC
iLIMS
United States
LETEC SARL
Tetraed LIMS
France
LGC Limited
Kraken
United Kingdom
LIMS at work GmbH
Labmatica LIMS
Germany
lims+WARE
lims+WARE/ASP,
lims+WARE/Networks,
lims+WARE/Results,
lims+WARE/UNIX
United States
Limseo SARL
Solution Laboratoire
France
LINKSolutions SAA
LINKS V3.3 LIMS
Peru
Loc@soft
Lims.net
France
LTech Australia Pty. Ltd.
Lims1
Australia
Lyons Information Systems, Inc.
LLMS
United States
MAQSIMA GmbH
MAQSIMA LAB+
Germany
Mechatronics BV
L@SSIST
Netherlands
Megaware, Inc.
LIAS
United States
Metallurgical Systems Pty. Ltd.
MS-LIMS
Australia
Micronic Europe BV
Track-IT
Netherlands
MIPS NV
GLIMS
Belgium
Modul-Bio SAS
MBioLIMS
France
Mongoose Coding
Mongoose LIMS
United States
Mountain States Consulting, LLC
MSC-LIMS
United States
Moxie Informatics, LLC
Moxie
United States
Mukon CC
Skylims
South Africa
Myfab
Myfab LIMS
Sweden
National Agribusiness Technology Center
USALIMS
United States
National Cancer Institute
caLIMS
United States
Novatek International
NOVA-LIMS
Canada
Oasis Infotech Pvt. Ltd.
EnviroLIMS EWM, LIMZ-RD,

OasisLIMS, True-LIMZ CTL
India
Object Solutions Software AG
OS-LIMS
Switzerland
Ocimum Biosolutions Ltd.
Biotracker LIMS
India
Odysis SA
myLIMS
Switzerland
Online LIMS Canada Limited
OnRepo
Canada
Not to be confused with Odysis SA's

myLIMS product.
Products formerly called SAPPHIRE and

SQL*LIMS.
Not to be confused with Labsoft

Tecnologia Limitada's myLIMS product.
LIMS vendor
242
OnQ Software Pty. Ltd.
QLIMS
Australia
Open-source software solution
Bika LIMS
N/A
See Bika Lab Systems (Pty) Ltd. for

more info.
caLIMS
N/A
See National Cancer Institute for more

info.
OpenSpecimen
N/A
More information found on the

Krishagni Solutions Pvt. Ltd. page.
GNomEx
N/A
More information found on

[2]
SourceForge.net .
GNU LIMS
N/A
More information found on the project

[3]
page .
LAMA
N/A

[4]
website .
Open-LIMS
N/A

[5]
website .
openBIS
N/A

[6]
website .
OpenELIS
N/A

[7]
website .
Screensaver HTS LIMS
N/A
More information found on

[8]
SourceForge.net .
Open.Co Srl
ProLab.Q Chemical &

Manufacturing, ProLab.Q Food &
Beverage,
ProLab.Q LIMS, ProLab.Q Wine
Italy
Oracle Corporation
Oracle Health Sciences Clinical

Development Analytics
United States
Orsyx
eL@b
Israel
Oy Fision Ltd.
Broadsight LIMS
Finland
PANalytical BV
SPARCS
Netherlands
Pardus d.o.o.
eQMS::LIMS
Croatia
Pathology Data Systems Ltd.
Ascentos
Switzerland
pdv-software GmbH
pdv-lims 3
Germany
PerkinElmer Inc.
LABWORKS
United States
Persistent Systems Ltd.
ChemLMS
United States
Phylum SARL
Phylum.Laboratoire
France
Polisystem Informatica Srl
Analisi
Italy
Porter Lee Corporation
Crime Fighter BEAST
United States
Prevas AB
Mikon LIMS
Sweden
ProBioData GmbH
BioProcessDB
Germany
Process Solutions Canada Limited
LDMS
Canada
Prog4biz Software Solutions Ltd.
BookitLab
Canada
Former products were PathData,

ReproData, and ToxData.
Acquired from Agilent.
LIMS vendor
243
Progeny Software, LLC
Progeny LIMS
United States
Promadis Pty. Ltd.
Caseman
Australia
Promium, LLC
Element LIMS
United States
QBCon (Pty) Ltd.
Lab-i
South Africa
QUALIMS SARL
QUALIMS
France
Quality Systems International Corporation
VersaLIMS.NET, WinLIMS.NET
United States
Quartz Imaging Corporation
Quartz FA-LIMS
Canada
raytest Isotopenmessgeraete GmbH
Raphaela RS
Germany
Reston Stable Isotope Laboratory
LIMS for Lasers, LIMS for Light

Stable Isotopes
United States
RJ Lee Solutions, LLC
THEMIS
United States
RDS Nordest Srl
CQT2000 LIMS
Italy
Ross Group Inc.
UVIS
United States
RURO Inc.
ezColony, FreezerPro,
LIMS 24/7
United States
SampleNavigator BV
SampleNavigator
Netherlands
Sapio Sciences, LLC
Exemplar Biomarker Discovery,

Exemplar Dx LIMS,
Exemplar Research LIMS
United States
ScienTek Software, Inc.
iStability LIMS
United States
Sciformatix Corporation
SciLIMS
United States
Shimadzu Corporation
LIMSsolution
Japan
Sibio SAS
custom LIMS
France
Siemens AG
SIMATIC IT Unilab
Germany
Smallcapcrm IT Solutions Pvt. Ltd.
SCC LIMS
India
Sofcom (Private) Limited
Spectrum
Pakistan
SoftTrace Ltd.
SoftTrace LIMS
Ireland
Software for Life Sciences BV
LabScores
Netherlands
Software Point Oy
LabVantage BioBanking,
LabVantage LIMS,
LABVANTAGE Medical Suite,
TasteBOSS
WilabLIMS/LimsBOSS
Finland
Softwaresysteme Keeve GmbH
RHAPSODY LIMS
Germany
Spectra QEST Australia Pty. Ltd.
QESTField, QESTLab
Australia
STaCS DNA Inc.
STaCS
Canada
The RSIL is part of the U.S. Geological

Survey.
A LIMS designed for pharmaceutical

stability testing programs and stability
test management.
Previous products were called SibioCLE

and TraceLite.
Acquired by LABVANTAGE in April

2011. C5 LIMS was renamed to
"LABVANTAGE Medical Suite" in
December 2012.
LIMS vendor
244
Stanford University School of Medicine
MendeLIMS
United States
STARLIMS
United States
Stone Bond Technologies, LP
EE-LIMS, MicroLIMS
United States
Summit Research Services
Metabase
United States
Sylab Mditerrane
CALYPSO LIMS
France
System Approach, Ltd.
Lab Keeper
Russia
TechWare Incorporated
Logbook Discovery, TechWare

MainTrac
United States
The Edge Software Consultancy Ltd.
BioRails LIMS
United Kingdom
Thermo Scientific
Darwin, Galileo, Nautilus,

SampleManager, Watson
United States
Timeless Medical Systems
Timeless LIMS
Canada
Tribal Software, Inc.
LIMS Lyte, Tribal-LIMS
United States
Triestram & Partner GmbH
lisa.lims
Germany
Trilogy Group Limited
HAND, STAR, TAPS, TIME
United Kingdom
Two Fold Software Limited
Qualoupe LIMS
United Kingdom
U.S. EPA
FORMS II Lite
United States
UNIConnect LC
UNIFlow
United States
Valdata Systems USA, Inc.
Valdata LIMS
United States
Ventyx, Inc.
CCLAS
United States
Mincom Pty. Ltd. absorbed into Ventyx

along with CCLAS
on February 6, 2012.
Waters Corporation
NuGenesis 8
United States
NuGenesis 8 is a data management and

workflow package
of applications, including NuGenesis
Sample Management.
Wavefront Software, Inc.
Wavefront LIMS
United States
WESTcom Logiciels et Services SARL
ARES, EDIlab, LimsOnLine
France
White Point Systems, Inc.
NAPIS
United States
Yullin Technologies Co., Ltd.
LabMate Enterprise
South Korea
Bought by Abbott in 2010.
Note: a division of Thermo Fisher

Scientific, Inc.
LIMS vendor
245
Inactive LIMS vendors

Vendor
Headquarters
(Country)
4S Information Systems Ltd.
DAWN LIMS
United States
While 4S still actively develops clinical software,

it no longer develops/distributes DAWN LIMS.
Accelrys, Inc.
Accelrys LIMS
N/A
Accelrys was acquired by Dassault Systmes SA on April

29, 2014.
Agencourt Bioscience Corp.
Galaxy LIMS
N/A
Bought by Beckman Coulter, Inc. in 2005.
ALTIK SAS
SOLUTION Laboratoire
N/A
Bought by Limseo SARL in September 2013.
Amersham Biosciences Corp.
Scierra LWS
N/A
Bought by General Electric.
APAC GmbH
APA-LIMS
Germany
Company is still active but seems to no longer offer

APA-LIMS.
Applied Biosystems, Inc.
SQL*LIMS
N/A
Merged with Invitrogen Corporation in November 2008

to form Life Technologies Corporation.
LABVANTAGE Solutions, Inc. purchased
SQL*LIMS from Life Technologies in 2009.
bizzApps
Quality Manager
N/A
On August 16, 2013, OpenText Corporation acquired

Cordys Holdings BV,
and by extension bizzApps BV.
Bridge-Soft, LLC
QMS, VDP
N/A
Per owner, LIMS no longer offered and business will be

closed by end of 2014.
CambridgeSoft Corporation
Workflow LIMS
N/A
Bought by PerkinElmer Inc. in March 2011.
CARDIAC AS
IMATIS LIMS
N/A
Split into two entities: Baze Technology AS

and IMATIS AS
Clondiag Chip Technologies

GmbH
PARTISAN arrayLIMS
N/A
Rebranded to Alere Technologies GmbH

in 2010, apparently ending PARTISAN.
Creon Lab Control AG
Q-DIS/QM
N/A
Bought by Waters Corporation. LIMS phased out?
Datasign AG
KinLIMS
N/A
Bought by Unilog S.A. in 2001.
EKM Corporation
LABTrack
N/A
Former reseller of LABTrack, LLC's LABTrack software.
GraphLogic, Inc.
Sequencing LIMS, Service

Center LIMS
N/A
The company dissolved November 21, 2011.
Green Mountain Logic, Inc.
LabPas
N/A
Bought by Phase Forward Incorporated in 2007. LabPas

also carried on to Phase Forward.
Hollison Technologies
CIMS
United States
Company still active but no longer appears to offer CIMS.
Honeywell Process Solutions
Honeywell LIMS
United States
Honeywell is still an active vendor; however, they

discontinued their LIMS in 2014.
i-punkt Software GmbH
LABORA
N/A
Bought by MAQSIMA GmbH in 2001.
IMR Technologies LLC
MATware
N/A
Originally a division of IMR Test Labs,

both IMR Tech and MATware appear defunct.[citation needed]
INLOG SA
ANALYS, EDGELab
N/A
On 31 August 2014, INLOG ceased functioning as "a

Haemonetics Company"
and was fully absorbed into Haemonetics Corporation.
InnaPhase Corporation
Galileo, Newton,
Thompson, Watson
N/A
Acquired by Thermo Scientific in 2004, with Thermo

continuing development on some products.
Additional notes
LIMS vendor
246
Instem Computer Systems Ltd.
DATATOX-F1
N/A
Sold and changed name to Instem, Ltd. in 2000.

Name changed again to Capula, Ltd. in 2002.
LIMS assumably discontinued.
LabHQ Ltd.
LabHQ
N/A
LabHQ LIMS was transferred to SkySource Ltd, and

LabHQ Ltd.
officially dissolved on March 5, 2013.
LabIT Solutions AB
LabMaster
N/A
Bought by Software Point Oy in 2010.

LabMaster now a Software Point product.
LabSys Ltd.
LabSys LIMS
N/A
LabSys Ltd. officially dissolved on May 22, 2010.
Lemm Tech Enterprises, Inc.
Labvironment
United States
The company is operational but it no longer offers

Labvironment.
Management Systems
Designers, Inc.
FLIMS
N/A
Bought by Lockheed Martin in 2007.
MBIS, Inc.
b.a.r.d. LIMS
Algeria
Formerly a product of Forensic Technology, Inc.
Mikon AS
Mikon LIMS
N/A
Bought by Prevas AB in 2007.
Mincom Pty. Ltd.
Mincom CCLAS
N/A
Acquired by ABB Group on May 9, 2011 and fully

integrated
into subsidiary Ventyx, Inc. on February 6, 2012.
Nuvotec, Inc.
OmniLIMS
N/A
Merged with Pacific EcoSolutions, Inc. to form Nuvotec

USA,
Inc. Later became Columbia Energy & Environmental
Services, Inc.
FreeLIMS
N/A
See the entry on LIMS at work GmbH for more info.
Orga Lab GmbH
CSI-LIMS
Germany
The company is operational but it no longer offers

CSI-LIMS.
Phase Forward Incorporated
LabPas LIMS, Waban LIMS
N/A
Acquired by Oracle Corporation in August 2010.

See article for full history.
ReTiSoft Inc.
Datapilot
Canada
Company still active, but Datapilot seems to have been

phased out as of 2013.
Sarla Technologies Pvt. Ltd.
PLIMS
India
While still active, the company phased out PLIMS in late

2014.
SkySource Ltd.
LabHQ
United
Kingdom
Changed name to Broughton Software Ltd.
Telecation
Aspen LIMS, Conifer LIMS
N/A
Telecation bought by OPS Systems in 2004.

OPS Systems bought by Hach Company in 2009.
Zumatrix, Inc. apparently supporting Aspen LIMS.
Tellac Applications
TELLAC'Suite
N/A
Bought by APILOG Automation group in 2001.

Marketed as QUALIMS.
Tieto Corporation
Seamless LIMS
Finland
Company still active, but product discontinued in roughly

late 2013.
Tropical Software Solutions,

Inc.
LabPartner
N/A
Per Florida Department of State, business inactive.
TUSC Computer Systems
METRIX
N/A
Changed name to TUSC IT Scripts.

Sold METRIX to LabWare, Inc.
Visual Access Health Systems

Pvt. Ltd.
VATIM
N/A
Web presence ended sometime in 2013

or 2014. Status not clear.
Waban Software, Inc.
Waban LIMS
N/A
Bought by Phase Forward Incorporated in 2009.

Waban LIMS now controlled by Phase Forward.
LIMS vendor
247
Wildtype Informatics LLC
Wildtype Linx
N/A
Dissolved (see vendor article for details)
YourLabData.com
Your Lab Data
N/A
The website ceased to operate sometime after February 9,

2014.
Zumatrix, Inc.
Matrix Gemini
N/A
Used to distribute and support Autoscribe Ltd.'s product.

Now absorbed into subsidiary Autoscribe Informatics Inc.
LIMS vendors with unknown status

Vendor
Headquarters
(Country)
Additional notes
Afrosoft International South Africa VeriLIMS

(Pty) Limited
South Africa
Web site defunct.
Computerised Laboratory
Applications (Pty) Ltd
VeriLIMS
South Africa
Web site defunct. Can't verify if

Afrosoft International South Africa (Pty) Limited
and their VeriLIMS product are related.
Dataplex Technologies, Inc.
Key Solutions
United States
Last update seems to be from 2005. In May 2012 website is blank

page.
Finna Technologies
LabAnalyst.NET
United States
First Align
FirstAlign Laboratory
Unknown
Is/was a division of Biber, Inc. FirstAlign.com dead.

BiberTech.com dead. BiberInc.com mostly dead.
INAS Datentechnik GmbH
QBase 5.0
Germany
Site under construction. LIMS/company may be defunct.
Ingensis Limited
TLIMS
Unknown
Website http:/ / www. ingensis. co. uk/ not updated since 11

December 2009.
LabPlus Technologies, Inc.
LabPlus, LimsLink
United States
Website is defunct though business license still active. Status

unknown.
Latent Logics Infosoft Pvt. Ltd.
Lab Pro 2004
India
Website was suspended by host in late 2013 or early 2014. Status

unknown.
LeanRP
Q-Cent
India
According to domain host, "domain name expired on 8/29/2014 and

is pending renewal or deletion."
MedToxSoft, LLC
MedTox LIMS
United States
Website is incomplete and hasn't been updated since 2011.
MurriWare SAS
SILAB
Unknown
BonsaiLIMS
N/A
More information found on SourceForge.net
SIGLa
N/A
More information found on the project website
Qualtrace International Ltd.
QualTrace LIMS
Unknown
SAME Sistemas Informticos SA
CALIBRA2002,
LIMS2000i
Spain
Website doesn't function; status unknown.
Siri Technologies Pvt. Ltd.
SIRI LIMS
India
Sullivan Software
LABTROL
Unknown
SWAG SL
QA-Lab, QA-Traza,
W-Instrum, WQC
Spain
Xenco Software
EnviroLIMS
United States
Now known as Xenco Laboratories.

Not clear what name of LIMS is now.
[9]
[10]
LIMS vendor
248
References
[1] http:/ / sourceforge. net/ projects/ bika/
[2] http:/ / sourceforge. net/ projects/ gnomex/
[3] http:/ / savannah. gnu. org/ projects/ lims/
[4] https:/ / launchpad. net/ mousedb
[5] http:/ / www. open-lims. org/ home. html
[6] http:/ / www. cisd. ethz. ch/ software/ openBIS
[7] http:/ / openelis. org/
[8] http:/ / sourceforge. net/ projects/ screensaver/
[9] http:/ / sourceforge. net/ projects/ bonsailims/
[10] http:/ / luar. dcc. ufmg. br/ sigla/
ELN vendor
respectively.
An ELN vendor is an entity (business, company, corporation, etc.) which provides electronic laboratory notebook
(ELN) software or software packages. The ELN software may be very generalized to handle a great number of
laboratory situations, or it may be very specific to handle the needs of a certain field of study.
Active ELN vendors

Vendor
Key ELN offering(s)
Headquarters
(Country)
AAC Infotray AG
Limsophy DoDoc
Switzerland
Advanced Chemistry Development, Inc.
Electronic Notebook for

Academia
Canada
LogiLab ELN
India
AgiLab SAS
ELN BioLab, ChemLab, and

FormuLab
France
AgileBio
LabCollector
United States
OpenLAB ELN
United States
Amphora Research Systems, Inc.
CompliantPad, OpenELN,
PatentPad, PatentSafe
United States
Arxspan, LLC
ArxLab Electronic Notebook
United States
Asseco Danmark A/S
shareSignELN
Denmark
ATGC Labs, LLC
ActiveLN
United States
BiochemLab Solutions
Electronic Lab Notebook
United States
BioSistemika LLC
GENEIO ELN
Slovenia
ChemBytes
Espresso ELN
Switzerland
Additional notes
ELN vendor
249
ChemInnovation Software, Inc.
CBIS
United States
CompuDrug International, Inc.
Laboratory Manager Plus
United States
Core ELN
United States
Dassault Systmes SA
Accelrys ELN
France
DeltaSoft, Inc.
ChemCart ELN
United States
Dotmatics Limited
Studies Notebook
United
Kingdom
Easylab Ltd.
Easylab
Turkey
eNovalys SAS
ePro
France
enso Software GmbH
ensochemLab
Germany
Evolvus Pvt. Ltd.
India
EZQuant Ltd.
EZQuant-ELN
Israel
FORMULATOR Software, LLC
FORMULATOR
United States
Genohm BVBA
SLims
Belgium
HiTec Zang GmbH
eJournal
Germany
iAdvantage Software, Inc.
eStudy
United States
ID Business Solutions Ltd.
BioBook, ChemBook,
E-WorkBook
United
Kingdom
Kalliste Systems, Inc.
Kalliste eSystems
United States
KineMatik Ltd.
eNovator
United States
Labage SA
benchsys-lab
Belgium
Lab-Ally LLC
CERF, RSpace
United States
LabArchives, LLC
LabArchives
United States
labfolder GmbH
labfolder
Germany
LABTrack, LLC
LABTrack
United States
eNotebook
United States
LabWare, Inc.
LabWare ELN
United States
Laurus Infosystems Pvt. Ltd.
Chemia
India
NoteBookMaker, LLC
NoteBookMaker
United States
Online LIMS Canada Limited
Online Worksheet
Canada
Open source software solution
CyNote
N/A
eLabFTW
N/A
More information found on the project site
eln
N/A
Indigo ELN
N/A
LabTrove
N/A

[6]
the project site .
open enventory
N/A
Dassault acquired Accelrys, Inc. on April 29, 2014.
EKM Corporation was previously a distributor of

LABTrack.
[1]
[2]
[3]
[4]
[5]
[7]
and
ELN vendor
250
openBIS
N/A
PerkinElmer Inc.
E-Notebook
United States
Prog4biz Software Solutions Ltd.
BookitLab
Canada
quattro research GmbH
quattro/LJ
Germany
Research Innovations Limited
eCAT, RSpace
Scotland
RURO Inc.
Sciency
United States
Scilligence Corporation
Scilligence ELN
United States
Shanghai Holo Sci-infor Co., Ltd.
China
shazino SAS
hivebench
France
Siemens AG
SIMATIC IT R&D
Germany
SPLhost, Inc.
Datacloud
United States
STARLIMS Electronic
Notebook
United States
Studylog Systems, Inc.
Study Director
United States
SunBio IT Solutions Pvt. Ltd.
SunBio ELN
India
Synbiota Inc.
Synbiota
Canada
Sysment Kft.
Sysment Notebook
Hungary
Systat Software Inc.
SigmaCERF
United
Kingdom
Terrington York Ltd.
Labsform
United
Kingdom
Textco BioSoftware, Inc.
Gene Inspector
United States
The Edge Software Consultancy Ltd.
BioRails ELN
United
Kingdom
Waters Corporation
NuGenesis 8
United States
Not a stand-alone ELN, but has an ELN plug-in.

[6]
[8]
More info here
and here .
Lab-Ally LLC is the North American distributor of

RSpace.
Still in beta as of May 2014
NuGenesis 8 is a data management and workflow

package
of applications, including NuGenesis ELN.
ELN vendor
251
Inactive ELN vendors

Vendor
Key ELN offering(s)
Headquarters
(Country)
Accelrys, Inc.
Accelrys ELN, Contur

ELN/iLabber
N/A
Accelrys was acquired by Dassault Systmes SA on April 29, 2014.
ArtusLabs, Inc.
Ensemble ELN
N/A
Bought by PerkinElmer Inc.
CambridgeSoft
Corporation
E-Notebook
N/A
Bought by PerkinElmer Inc. in March 2011.
Cognium Systems SA
iPad ELN
N/A
Dissolved in the summer of 2014.
Contur Software AB
Contur ELN/iLabber
N/A
Changed name of ELN from ConturELN to iLabber July 19, 2011.

Was acquired by Accelrys, Inc. in 2011.
Laboratory Data Solutions Labnotes

Ltd.
N/A
The company officially dissolved on September 10, 2013.
Labtronics Inc.
Nexxis ELN
N/A
Bought by PerkinElmer Inc. in May 2011.
Neudesic, LLC
Neudesic ELN
United States
While the company is still active, it seems Neudesic

no longer markets its ELN.
Open source software

solution
Electronic Laboratory
Notebook
N/A
The project terminated in the winter of 2007.

solution
LabJ-ng
N/A
No project release since 2007: SourceForge.net

solution
tags4lab
N/A
No releases; last update 2009: SourceForge.net

solution
The Monster Journal
N/A
No update to project since 2009: SourceForge.net
Rescentris, Inc.
CERF
United States
Was absorbed into irisnote, Inc. then Lab-Ally LLC. See Rescentris
entry for more history.
SparkLix Bio IT Corp.
SparkLix
N/A
The service was discontinued in the summer of 2014.
Symyx Technologies Inc.
Symyx ELN
N/A
Merged with Accelrys, Inc. in 2010.
VelQuest Corporation
SmartLab gmpELN
N/A
Was bought by and absorbed into Accelrys, Inc. in January 2012,

with SmartLab becoming "Accelrys Lab Execution System",
a laboratory execution system.
Additional notes
[9]
[10]
[11]
ELN vendors with unknown status

Vendor
Key ELN offering(s) Headquarters

(Country)
Open source software solution MyLabBook
References
[1] http:/ / cynote. sourceforge. net/
[2] http:/ / www. elabftw. net/
[3] https:/ / launchpad. net/ eln
[4] http:/ / ggasoftware. com/ opensource/ indigo/ eln
[5] http:/ / sourceforge. net/ projects/ labtrove/
[6] http:/ / www. labtrove. org/
N/A
Additional notes
Still in pre-alpha on SourceForge: SourceForge.net
[12]
ELN vendor
252
[7] http:/ / sourceforge. net/ projects/ enventory/

[8] https:/ / wiki-bsse. ethz. ch/ display/ openBISDoc/ openBIS+ for+ ELN
[9] http:/ / sourceforge. net/ projects/ labj/
[10] http:/ / sourceforge. net/ projects/ tags4lab/
[11] http:/ / sourceforge. net/ projects/ monsterjournal/
[12] http:/ / sourceforge. net/ projects/ mylabbook/
CDMS vendor
respectively.
An CDMS vendor is an entity (business, company, corporation, etc.) which provides chromatography data
management system (CDMS; or chromatography data system or CDS) software or software packages. The CDMS
software may be very generalized to handle a great number of laboratory situations dealing with chromatography, or
it may be very specific to handle the needs of a specific type of sample analysis.
Active CDMS vendors

Vendor
Key CDMS offering(s)
Headquarters
(Country)
Advanced Chemistry Development, ACD/AutoChrom MDS, ACD/Chrom

Inc.
Workbook,
ACD/ChromGenius
United States
EZChrom, Galaxie,
OpenLAB CDS
United States
Beijing Teleh Electronic Tech Co.,

Ltd.
Bio-2000
China
Bruker Corporation
HyStar
United States
ChemSW, Inc.
GPMAW, Mass Spec Tools
United States
DataApex, spol. sro
Clarity
Czech Republic
Dionex Corporation
Chromeleon
United States
E-Chrom Tech Co., Ltd.
Chromatography Data System
Taiwan
H&A Scientific, Inc.
PC/Chrom
United States
Jasco Europe Srl
Chromnav
Italy
Justice Laboratory Software, Inc.
Chrom Perfect LSI, Chrom Perfect Spirit
United States
LabLogic Systems Limited
Laura 4
United
Kingdom
OpenChrom
N/A
Additional notes
Acquired by Thermo Scientific in May

2011.

[1]
website .
CDMS vendor
253
PerkinElmer Inc.
Chromera
United States
Promium, LLC
Mint Miner
United States
PSS Polymer Standards Service

GmbH
WinGPC UniChrom
Germany
Schlumberger Limited
Malcom
United States
Shimadzu Corporation
LabSolutions
Japan
Thermo Scientific
Atlas CDS, ChromQuest,

EnviroLab Forms, QuanLab Forms
United States
Waters Corporation
Empower 3
United States
Yullin Technologies Co., Ltd.
MultiChro
South Korea
Inactive CDMS vendors

Vendor
Key CDMS offering(s) Headquarters

(Country)
Additional notes
Labtronics Inc. LimsLink CDS
N/A
Varian, Inc.
N/A
Agilent Technologies, Inc. acquired Varian in May

2010,
integrating Varian's holdings fully.
Galaxie
References
[1] http:/ / www. openchrom. net/ main/ content/ index. php
LIS vendor
254
LIS vendor
Looking for non-clinical, more sample-based informatics systems? You may want to also check out the LIMS vendor page.
respectively.
A LIS vendor is an entity (business, company, corporation, etc.) which provides laboratory information system
(LIS) software or software packages. The LIS software may be very generalized to handle a great number of clinical
situations, or it may be very specific to handle the needs of a specific clinical setting.
Given the way some vendors choose to market their product, and also considering the continued blurring of
differences between a LIS and a laboratory information management system (LIMS), some products may have
obvious LIS functionality yet are marketed as a LIMS. For the purposes of presenting a thorough list of options,
vendors that offer a software product obviously tailored to clinical and healthcare-related labs despite being
marketed as a LIMS will also be considered a LIS vendor.
Finally, a LIS may also appear as a fully-featured module within a hospital information system (HIS), for example.
Active LIS vendors

Vendor
Key LIS offering(s)
Headquarters
(Country)
A&T Corporation
CLINILAN
Japan
Advanced Business Software
PHIMS
United States
Agfa HealthCare NV
Bioserveur, Hexalis
Belgium
Akhil Systems Pvt. Ltd.
Miracle LIS
India
Alfa Wassermann, Inc.
Alfa LIS
United States
Alphasoft GmbH
Unilab-700
Germany
American Soft Solutions Corp.
PROLIS
United States
AP-Visions, LLC
xLab
United States
Apex HealthWare, LLC
Apex LIS
United States
Aspyra, LLC
ASPYRA LIS
United States
Attune Technologies Pte. Ltd.
Attune LabKernel
Singapore
BARTELT GmbH
datalabX
Austria
Bio-Analytical Technologies Pvt. Ltd.
PathlabSys
India
BioFortis, Inc.
Labmatrix
United States
Birlamedisoft Pvt. Ltd.
Maxim LIS
India
Additional notes
Hexalis and Bioserveur are today only deployed in

the French market.
LIS vendor
255
Bodgro Technische Automatisering

CV
LabTrain
Netherlands
BtB Software, LLC
BtB Software
United States
Busysoft Systems Pvt. Ltd.
LabMate
India
CCIF SARL
Winlabo SGL
France
Cegeka NV
CorLabs
Belgium
Cerebrum Corporation
LABdivus Clinical
United States
Cerner Corporation
Millennium PathNet,
PowerChart
United States
Clarisys Informatique SARL
Clarilab, MCA, OneLink
France
Clin1, LLC
Clin1 Suite
United States
Clinical Systems Ltd.
ClinAxys II
United Kingdom
ClinLab, Inc.
ClinLab LIS
United States
Comp Pro Med, Inc.
Polytech Laboratory
Information System
United States
CompuGroup Medical AG
CGM Analytix, LabDAQ
Germany
CompuMedical Health Care Solutions

SAE Co.
Rx-Care LIS
Egypt
Computer Service and Support, Inc.
CSS LIS
United States
Computer Technology & Services

SARL
CTServ LIS
Lebanon
Comtron Corp.
Labgen LIS
United States
Custom Software Ltd.
NetAcquire LIS
Ireland
Desarrollo Aplicaciones Sanitarias SL
SilverLab
Spain
DL Sant SAS
Odancio
France
Diamond Computing Company
LabGEM
United States
Dorner GmbH & Co. KG
X/Lab
Germany
Emergency Care Dictation Services,

Inc.
Empower HIS
United States
Entre Technology Group
GenesysNSL
United States
Exleaz Solutions Limited
MediEaz LIS
United Kingdom
Fonet Bilgi Teknolojileri A..
FONET LIS
Turkey
Glivytech Services Pvt. Ltd.
Glivytech LIS
India
Haemonetics Corporation
EdgeLab, Sapanet
United States
Hemasoft Software SL
e-Delphyn LIS
Spain
Hex 'ff' Inc.
LAB/HEX LIS
United States
HISTONE Informatique SARL
LAM400
France
IN2 Ltd.
BioNET LIS
Hungary
Infomed C.S.
sLis
Greece
Information Management Services, Inc. BSI, SEER*DMS,

SEER*STAT, SQUISH
United States
Company was formerly named Clinical Software

Solutions.
A HIS with a LIS module
LIS vendor
256
Innovasystem LLC
LIS Innovasystem
Russia
Inovapar Solues Ltda.
Motion LIS
Brazil
Instem LSS Limited
Centrus, Provantis
United Kingdom
Integrated Business Solutions Group,

LLC
LABLION
United States
Integrated Software Solutions Pty. Ltd.
OMNI-Lab
Australia
InterSystems Corporation
TrakCare
United States
IT Easy Software Solutions
WebLIS Professional
Phillipines
ITs 4 H.E.ALT.H s.a.l
AviCenna LIS
Lebanon
J&S Medical Associates, Inc.
LabTrak
United States
Kameda Infologics Pvt. Ltd.
YASASII
Japan
LabSoft, Inc.
Beethoven II, EZLink,

LabNet
United States
Labthroughput
LTP Achiever
United States
LabWare, Inc.
LabWare LIMS
United States
LigoLab, LLC
LigoLab LIS
United States
LRS Health Pty. Ltd.
MediPATH, MediPATH AP
Australia
Margy Tech Pvt. Ltd.
iLIS
India
McKesson Corporation
Horizon Lab
United States
Medasys SA
DxCare, DXLAB, DxLabOne
France
MEDCOM Information Systems, Inc.
MEDCOM Lab Manager
United States
MEDHOST, Inc.
MEDHOST LIS
United States
Merge Healthcare Inc.
Merge LIS
United States
MIPS NV
GLIMS
Belgium
Moonchase
Lab Online
Belgium
Mukon CC
PathWay
South Africa
Multidata Computer Systems, Inc.
MultiTech
United States
Netika SARL
KaliLab, KaliSil
France
NeTLIMS NJ, LLC
AutoLims
United States
Neusoft Medical Systems Co., Ltd.
Neusoft LIS
China
NoemaLife SpA
DNLab
Italy
Northern Software, Inc.
eLab.Sys
United States
Nortec Software, Inc.
Nortec LIS
United States
NovoPath, Inc.
NovoPath
United States
NTT DATA Corporation
Optimum Clinicals
Japan, United
States
OGER SYSTEMS
Oger Medical Information

System
Saudi Arabia
C4G BLIS
N/A
OpenSpecimen
N/A
More information found on the Krishagni Solutions

Pvt. Ltd. page.
LIMS software with additional LIS-like functionality
LIS software marketed as a LIMS
[1]
LIS vendor
257
OpenELIS
N/A
Orchard Software Corporation
Orchard Harvest
United States
Pact Sotraig SARL
ADLAB-400
France
Pathagility, LLC
Pathagility
United States
PCS Technology Limited
Lab Plus
India
pdv-software GmbH
PDV-LIS II
Germany
Philips Medical Systems BV
LABOSYS, MICROS
Netherlands
Physicians Independent Management

Services, Inc.
PathX
United States
Pixeon Comrcio e Desenvolvimento

de Software Ltda.
X Clinic Nexus
Brazil
Point of Care Solutions Pty. Ltd.
v-LAB
Australia
Prestij Yazlm ve Bilgi Sistemleri
Winsoft LIS
Turkey
Psyche Systems Corporation
WindoPath
United States
Quality Software Systems, Inc.
LabHealth
United States
Rabbit Healthcare Systems
Rabbit EHR
United States
Roche Diagnostics Limited
cobas infinity IT solutions
Switzerland
Schuyler House
SchuyLab
United States
[2]
Product may not be available in the U.S.
Seacoast Laboratory Data Systems, Inc. SurroundLab
United States
Siemens AG
Servolab, TD-Synergy
Germany
Unclear what happened to former product NOVIUS

Lab.
SLCLAB Informtica SL
ALFA21
Spain
More information found on www.slclab.com.
Soft Computer Consultants, Inc.
SoftLab
United States
SofTov Medical Systems Ltd.
AutoLab
Israel
Note: SofTov is NeTLIMS' regional distributor of

AutoLab in the Middle East.
Software Point Oy
LABVANTAGE Medical
Suite
Finland
STAPRO s.r.o.
FONS Openlims
Czech Republic
Sunquest Information Systems, Inc.
ICE, Sunquest Laboratory
United States
Suvarna Technosoft (P) Ltd.
Suvarna-HIS
India
Sysmex Corporation
Delphic LIS
Japan
Delphic LIS may only be available in the Australia

and New Zealand markets.
Systelab Technologies SA
Modulab
Spain
Swisslab GmbH
SWISSLAB
Germany
Synbiotix Ltd.
Synbiotix Hospital
Information System
United Kingdom
Tainosystems Inc.
Silabmed
Canada
Technidata SAS
TD-Synergy
France
Tendercare Infotech India Pvt. Ltd.
Capsule LIS
India
TerraSystems
MiniLIS
Ukraine
Timeless Medical Systems
Timeless LIMS
Canada
LIS vendor
258
Universal Software Solutions, Inc.
VersaSuite LIS
United States
vision4health Laufenberg & Co.
molis
Switzerland
XIFIN, Inc.
XIFIN LIS Anywhere
United States
Xybion Corporation
Pristima Suite
United States
molis originally owned by Sysmex Corporation.

CompuGroup Medical AG
acquired vision4health in January 2014.
Inactive LIS vendors

Vendor
Key LIS offering(s)
Headquarters
(Country)
ACT Medisys, Ltd.
INTEGO
N/A
Bought by iSoft.
Antek HealthWare, LLC
LabDAQ
United States
Merged into CompuGroup Medical, Inc. December 31, 2011.

See Antek record for more info.
Antrim Corporation
Answers Medical Information

Systems
N/A/
After being bought by Sunquest Information Systems, Inc. in

1996,
Sunquest was bought by Misys plc in 2001.
Benetech, Inc.
G*LIS
Canada
Company still active, but stopped marketing G*LIS sometime

after May 1, 2013.
BCS Limited
Masterlab
N/A/
After being bought by Torex PLC in 2002,

Torex was bought by Clinisys Solutions Limited in 2005.
Biomar Technologies, Inc.
LAB Wizard
N/A
Went bankrupt.
Cambridge Biotech Software,

Inc.
POLARIS
N/A
Company officially dissolved August 15, 2008.
CDS Group, Ltd.
TelePath, DDMS
N/A
Bought by ACT Medisys, Ltd.
Dedalus SpA
Dedalus LIS
Italy
Company still active but no longer offers LIS.
Eclipsys Corporation
Sunrise Laboratory
N/A
See Allscripts. Eclispsys merged with Allscripts in 2010.
Elekta AB
IntelliLab
Sweden
The company discontinued marketing IntelliLab LIS on its

website sometime
between May and July 2013.
Health Science Systems
OPUS
N/A
Bought OPUS Healthcare Solutions, Inc and assumed its

name[citation needed].
OPUS Healthcare bought by Quality Systems, Inc. in 2010 and
merged with
NextGen Healthcare Information Systems, Inc.
Healthcare Management
Systems, Inc.
HMS Laboratory
N/A
Became MEDHOST, Inc. on Dec. 16, 2013.
IMPAC Medical Systems, Inc. IntelliLab
N/A
Bought by Elekta AB in 2005.
INLOG SA
EDGElab, SAPANET
N/A
On 31 August 2014, INLOG ceased functioning as "a

Haemonetics Company"
and was fully absorbed into Haemonetics Corporation.
IntelliData, Inc.
IntelliLab
N/A
Bought by IMPAC Medical Systems, Inc. in 2002.
ISYS/Biovation
Messenger
N/A
Website shut down in mid-2014. Status assumed dissolved.
Keane, Inc.
Keane Optimum
United States
Purchased by and absorbed into NTT DATA Corporation.
LAB-InterLink
LAB-Manager
N/A
Bought Labotix Automation, Inc. in 2000; took that name in

2007.
Additional notes
LIS vendor
259
Labotix Automation, Inc.
RRUSH
N/A
Bought by Cerner Corporation March 18, 2013.
LCI, Inc.
Hummingbird
N/A
Acquired by American HealthNet, Inc., which was then acquired

by
Healthland in 2009.
M/MGMT Systems, Inc.
M/LAB
N/A
Bought by Common Cents Systems, Inc. in 2006.
NFLC, Inc.
HYBRID
N/A
Company seems to be defunct. Only online evidence is a

canceled trademark for HYBRID in 2008.
SGS Cortex Quality Software
LAB/400
N/A
Was bought by Cegeka in 2005.
Sysware Healthcare Systems,

Inc.
SYSWARE LIS
N/A
Bought by Eclipsys Corporation in 2006.
Tieto Corporation
FlexLab/Kemi,
FlexLab/SymPathy
Finland
Company still active, but product discontinued in roughly late

2013.
TriFour Healthcare Ltd.
TriLab
South Africa
The company is still active but in middle to late September 2013

the company stopped
marketing its LIS TriLab on its website.
Triple G Corporation
ULTRA LIS
N/A
Bought by GE Medical Systems Information Technologies in

2003.
Visual Access Health Systems

Pvt. Ltd.
VATIM SOLUTIONS
N/A
Web presence ended sometime in 2013

or 2014. Status not clear.
William Woodard Associates
Winpath 98
N/A
Changed name to Sysmed Solutions Limited in 2003,

and then CliniSys Solutions Limited in 2004.
LIS vendors with unknown status

Vendor
Key LIS offering(s) Headquarters

(Country)
Beijing ZhiFang S&T Development DigitLab
China
Great Mind Solutions
LabReader
India
Quartesect Pvt. Ltd.
Cliemat
Unknown
True-Medix Diagnostics, Inc
PROLIS
Unknown
References
[1] http:/ / blis. cc. gatech. edu/ index. php
[2] https:/ / sites. google. com/ site/ openelisglobal/
Additional notes
On September 26, 2013, the LabReader.com domain

expired.
It remains unclear if the company is dead or not.
SDMS vendor
260
SDMS vendor
respectively.
An SDMS vendor is an entity (business, company, corporation, etc.) which provides scientific data management
system (SDMS) software or software packages. The SDMS software may be very generalized to handle a great
number of laboratory situations, or it may be very specific to handle the needs of a certain field of study.
Active SDMS vendors

Vendor
Key SDMS offering(s) Headquarters Additional notes

(Country)
LogiLab SDMS
India
OpenLAB ECM
United States
Core SDMS
United States
Poplar Solutions, LLC
Labcore SDMS
United States
STARLIMS
United States
Thermo Scientific
Data Manager
United States
Waters Corporation
NuGenesis 8
United States
NuGenesis 8 is a data management and workflow

package
of applications, including NuGenesis SDMS.
SDMS vendor
261
Inactive SDMS vendors

Vendor
Key CDMS offering(s) Headquarters

(Country)
Labtronics Inc. Nexxis SDMS
N/A
Additional notes
References
Open-source laboratory informatics software

Before adding a specific category to LIMSwiki, please review the LIMSWiki:Category guidelines article. It explains the general
guidelines that should be followed when creating a category.
This category is designated for any open-source laboratory informatics software tools, including LIMS, LIS, ELN,
CDMS, etc.

LIMSwiki mission Source: http://www.limswiki.org/index.php?oldid=19556 Contributors: Shawndouglas
Information Source: http://www.limswiki.org/index.php?oldid=15163 Contributors: Shawndouglas
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Laboratory informatics Source: http://www.limswiki.org/index.php?oldid=13729 Contributors: Andersjim, Jleecbd, LIMSinstitute, Mikelong88888, Shawndouglas, 2 anonymous edits
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Electronic laboratory notebook Source: http://www.limswiki.org/index.php?oldid=15248 Contributors: LIMSinstitute, Shawndouglas, 2 anonymous edits
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Health Insurance Portability and Accountability Act Source: http://www.limswiki.org/index.php?oldid=20678 Contributors: Shawndouglas
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Clinical Laboratory Improvement Amendments Source: http://www.limswiki.org/index.php?oldid=20683 Contributors: Shawndouglas
Health Level 7 Source: http://www.limswiki.org/index.php?oldid=20739 Contributors: Shawndouglas
ISO 9000 Source: http://www.limswiki.org/index.php?oldid=20871 Contributors: Shawndouglas
ISO/IEC 17025 Source: http://www.limswiki.org/index.php?oldid=20870 Contributors: Shawndouglas
ISO/TS 16949 Source: http://www.limswiki.org/index.php?oldid=20873 Contributors: Shawndouglas
The American Society of Crime Laboratory Directors/Laboratory Accreditation Board Source: http://www.limswiki.org/index.php?oldid=20895 Contributors: Shawndouglas
The NELAC Institute Source: http://www.limswiki.org/index.php?oldid=20901 Contributors: Shawndouglas
LIMSWiki:LIMSforum and LIMS/LI forum posts Source: http://www.limswiki.org/index.php?oldid=21009 Contributors: Shawndouglas
Laboratory, Scientific, and Health Informatics Buyer's Guide Source: http://www.limswiki.org/index.php?oldid=20192 Contributors: Eusoft srl, Shawndouglas
LabLynx, Inc. Source: http://www.limswiki.org/index.php?oldid=21062 Contributors: LIMSinstitute, Shawndouglas
LABVANTAGE Solutions, Inc. Source: http://www.limswiki.org/index.php?oldid=19167 Contributors: Shawndouglas
LabWare, Inc. Source: http://www.limswiki.org/index.php?oldid=20984 Contributors: Ekrasovec, Shawndouglas
STARLIMS Corporation Source: http://www.limswiki.org/index.php?oldid=19453 Contributors: Shawndouglas
Thermo Scientific Source: http://www.limswiki.org/index.php?oldid=20955 Contributors: Shawndouglas
LIMS vendor Source: http://www.limswiki.org/index.php?oldid=21008 Contributors: Admin, Andersjim, Asouza, Atgclabs, Eusoft srl, Furosa, Jrjoyce, Kklimswiki, Mbraspen, Michael, Orsyx,
Rjoseph, Shawndouglas, Slclab, Sowmya.MC, 3 anonymous edits
ELN vendor Source: http://www.limswiki.org/index.php?oldid=20261 Contributors: Aacharya, Admin, Atgclabs, Invasifspecies, Jsdraw, Mbraspen, Mukunth, NicolasCARPi, Shawndouglas, 2
anonymous edits
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SDMS vendor Source: http://www.limswiki.org/index.php?oldid=19471 Contributors: Mukunth, Shawndouglas, 2 anonymous edits
Open-source laboratory informatics software Source: http://www.limswiki.org/index.php?oldid=8445 Contributors: Shawndouglas
262

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The Complete Guide To LIMS & Laboratory Informatics - 2015 Edition

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The Complete Guide To LIMS & Laboratory Informatics - 2015 Edition

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The Complete Guide to LIMS

& Laboratory Informatics

2. Introduction to Informatics in the Laboratory

Informatics (academic field)

3. Informatics Across Several Industries

4. All about LIMS and LIS

Laboratory information management system

Laboratory information system

LIMS and laboratory informatics questionnaire

5. More Laboratory Informatics Applications

Electronic laboratory notebook

Laboratory execution system

Scientific data management system

Chromatography data management system

6. Related Standards and Compliance

21 CFR Part 11/Audit guidelines and checklist

Good Automated Laboratory Practices

Good Automated Manufacturing Practice

Health Insurance Portability and Accountability Act

Health Insurance Portability and Accountability Act/Audit guidelines and checklist

Clinical Laboratory Improvement Amendments

The American Society of Crime Laboratory Directors/Laboratory Accreditation Board

The NELAC Institute

7. Laboratory Informatics Resources

LIMSWiki:LIMSforum and LIMS/LI forum posts

Laboratory, Scientific, and Health Informatics Buyer's Guide

8. Key Laboratory Informatics Vendors

LABVANTAGE Solutions, Inc.

9. Laboratory Informatics Vendor Directory

Open-source laboratory informatics software

Image Sources, Licenses and Contributors

1. About the Content of This Guide

2. Introduction to Informatics in the

As representation and complexity

As an influence which leads to a transformation

reviewing information in order to effectively derive value and meaning

Technologically mediated information

Information and semiotics

http:/ / books. google. com/ books?id=VupFqa3IJiUC

Informatics (academic field)

A computer used at China's 2002 National Olympiad in

While the field of informatics encompasses the study of

Informatics (academic field)

Informatics (academic field)

Informatics (academic field)

http:/ / books. google. com/ books?id=MOIW12eOvJsC

An Eppendorf thermal cycler as an example of a

Sub-elements in laboratory informatics

Technology of laboratory informatics

Chromatography data management systems (CDMS)

3. Informatics Across Several Industries

Bioinformatics vs. computational biology

Major research areas

Gene expression analysis

Protein expression analysis

Cancer mutation analysis

Comparative and computational genomics

Biological systems modeling

Computational evolutionary biology

Structural bioinformatic approaches

The idealized evolution of a gene lines is shown from a common

One of the key ideas in bioinformatics is the notion

Software and tools