February 2011

A supplement to

Chromatography
Data Systems
Boost Workflow
CDS solutions standardize operations, reducing wasted efforts and variability in the lab.

» by Chris Stumpf, Steven Eaton and Mark Harnois, Waters Corp.

A
cross a variety of occur in discovery, development or
industries, mergers QC environments. These individu-
and acquisitions, als regularly perform manual data
outsourcing of non- transfer for backups, transcriptions
core competency activities, and for report writing, and calcula-
intense competition are driving tions in unregulated spreadsheets.
science-driven organizations In such instances, an automated
towards standardization of software workflow has the poten-
laboratory operations. The reduc- tial to significantly improve labora-
tion of waste and variability are key tory productivity and reduce the risk of
benefits of standardizing operations non-compliance. For example, in a chroma-
and are often achieved by implementing tography laboratory, the manual steps out-
Lean Six Sigma practices. Eliminating lined above are sometimes necessary because
wasteful steps in any given process can the chromatography data system (CDS) isn’t
lower product cost structures and in turn capable of automated procedures and/or the
increase company revenues. A decrease in vari- analyst must combine results from several different
ability can not only improve product quality, but laboratory systems (e.g., liquid chromatography (LC),
also lower costs by reducing the risk of batch failures gas chromatography (GC) and mass spectrometry (MS)).
or product recalls. There are a number of avenues to Contemporary CDS solutions; however, are now able to
process standardization such as implementing stan- facilitate chromatography workflow standardization by
dard operating procedures (SOPs), leveraging new tech- supporting different instrumentation types (LC, GC and MS)
nologies, or organizing workspaces. The following will focus and vendors while automating data management steps that had
on a technology-centric approach, the use of a data acquisition previously required manual intervention.
and analysis software platform to facilitate standard laboratory
workflows. Defining CDS communities
To define a CDS solution that has the requisite functionality to
Automated workflow help standardize chromatography operations, one must consider the
Laboratory staff versatility and capability are assets to every organization; needs of three user communities: chromatographers, IT professionals and
however, they must often allocate time for non-valued added tasks that may regulatory compliance experts. A chromatographer community likely

Chromatography software can control MS instruments, acquire and pro-
cess MS data.
A UPLC-MS-MS system that can be supported by chromatography software.
spans a range of user skill levels and will benefit from having access to dif-
ferent user interfaces. For example, the power user would be given a fully
functional interface for performing everything from method development
to routine analyses whereas a walk-up user would be presented with a more
limited open-access sample login interface. An additional requirement for
the chromatographer would include the ability to access a variety of chro-
matography methodologies (LC and GC) and detectors (PDA, MS and ELS),
as well as perform calculations and reporting using automated tools.
Although nearly all of the CDS solutions on the market today sat-
isfy most chromatographer user requirements, few meet the needs of IT.
Simply put, IT professionals seek a CDS platform that is “Designed for the
Enterprise”— i.e., one that can be rapidly deployed and is easy to maintain
across a global organization. Multi-vendor instrument control aligns with
these requirements as it allows for laboratory system consolidation and
standardized data formats. However, since no CDS solution supports all
instruments on the market, the ability to import and convert data generated
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on external systems would help further satisfy
the data standardization goal. IT professionals
also look for software solutions that are highly
scalable—from workstation, to workgroup, and
finally to enterprise. This allows companies to
easily grow their CDS solution as needs expand.
Once a CDS solution reaches workgroup or enter-
prise scale, it must support wide-area network
(WAN) architectures and software virtualization
for redundancy and maximum uptime, as well as
make use of enterprise database capabilities like
distribute computing (as provided by technology
companies such as Oracle). Lastly, the IT land-
scape in many companies consists of computing
hardware of different capabilities. Citrix Systems
offers solutions that allow for CDS deployment in
a remote desktop environment helping to over-
come obstacles related to PC hardware limitations
such as older hardware and non-Windows plat-
forms. These solutions also limit system software
validation to only the servers that host the CDS
and not the clients.
The last user for consideration is the regulatory
compliance expert. For these individuals, flexibility is key as a CDS may
need to satisfy different regulatory requirements depending on which
country the product undergoing chromatographic testing will be sold.
Hence, a CDS that provides a configurable or “switch-on” approach to
regulatory compliance so that deployment can be adapted to meeting
U.S., European, Japanese, or other regulatory body requirements is criti-
cal. A compliant-ready CDS will implement compliance safe-guards
following a three step approach: (a) provide 21 CFR Part 11 or Annex
11 safe guards to the CDS that provides unique logins/passwords, audit
trails, and electronic signatures, (b) embed a relational database to aid
with data traceability, and (c) provide a separated network architecture
so that access to test data can be physically restricted within a locked
data center.
Data traceability
Although compliant-ready features in CDS solutions are necessary
to address bureaucratic documentation requirements, a capability such
as data traceability can also help companies identify root causes during
product inquiries—an additional benefit of software standardization.
Embedding the relational database not only secures data, but also
automates routine calculations and report creation which can improve
the chromatographer’s productivity. Finally, automated verification
technology in the CDS software rounds out the requirements of the
compliance expert since laboratory systems undergo numerous soft-
ware validation steps throughout the course of the year, e.g., software
upgrades, adding new instruments, instrument repairs, etc.
Conclusion
Current global market conditions are compelling organizations to adopt
quality programs, such as Lean Six Sigma practices, as a means to standard-
ize laboratory operations. The deployment of advanced and flexible scientific
software represents an effective means to achieve laboratory workflow stan-
dardization. Although chromatography data systems are generally considered
to be mature solutions largely focused on the needs of the chromatographer,
a small number of these platforms also address the challenges of IT profes-
sionals and regulatory compliance experts. Standardizing chromatography-
based operations by implementing a common CDS may prove to be a viable
strategy for those organizations wishing to reduce wasted effort and variability
(thereby improving margins and product quality) associated with product
testing in industries such as pharmaceutical, food and beverage, chemical and
environmental.