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Replacing LIMS Systems with SAP QM

ASUG Annual Conference May 2011


Mike Krug, QMS Inc., Beate Lindqvist, SAP AG
May 2011

Session Code: 2706

Public

Learning Points

1.

History of LIMS, SAP QM and the QM-IDI


(Instrument Data Interface).

2.

Evaluation of typical LIMS functionality and


SAP's solution to address these
requirements.

3.

See some examples of typical laboratory


processes covered by QM with SAP ERP.

4.

Learn about the latest updates in QM with


SAP ERP.

5.

See how you can increase your efficiency by


using quality management (QM) as a LIMS in
all your labs.

2011 SAP AG. All rights reserved.

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Agenda

History of LIMS and SAP QM


Evaluation of Typical LIMS Functionality and SAP's Solution
Examples for using SAP QM as LIMS
Latest Updates of SAP QM
Summary and Outlook

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History of LIMS and SAP QM

History of LIMS & SAP QM


LIMS Systems

SAP QM

Laboratory Information Management System


(LIMS).

Available since the R/3 3.0 Days.


Initially offered Quality Assurance functions.

Developed for Laboratories, specifically


around testing.
Typically found in pharmaceutical and other
process industries.

Was enhanced significantly in 4.0b


(calibrations), 4.7 (stability studies), 5.0
(multiple specs ).

Historically incorporating more Quality


Control capabilities along with reporting and
statistical analysis, e.g.

Strength was around COA generation


because of its tight integration with other
modules (SD, MM).

Sample Management
Calibrations
SPC

QM-IDI (QM Instrument Data Interface) to


connect SAP with the LIMS systems.

Initially was the Hands Down choice for


laboratories that needed to do a lot (> 1
million) samples per year.

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Historically: Best of Breed Approach


Combining both, LIMS & SAP QM
Use SAP QM, a LIMS solution, and connect via QM-IDI interface
QM for Quality Assurance
Product Testing Requirements repository
Ensures product isnt used or sold until it meets
QA requirements
COA generation
Vendor evaluation

LIMS for Quality Control


Test capturing
Calibration
Sample Management
Interfacing to Lab Equipment
Reporting and SPC

2011 SAP AG. All rights reserved.

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A Side-by-side Comparison LIMS vs. SAP QM


Data Entry / Usability

Calibration

Screens look about identical LIMS and SAP


(sometimes not as pretty).
Built-in customization in LIMS vs. preparation steps
(BUT: flexibility of configuration) in SAP.
Lab users historically have been able to familiarize
themselves with SAP just as quickly as a LIMS
system.

For LIMS solutions dependent on software vendor.


SAPs solution along with its integration to PM as a
strong option.
Many customers (including pharma customers) are
starting to use SAP calibrations.

Test Equipment Integration

Reporting / SPC

Interfacing to lab equipment is not easy and is


typically not standard.
Complexity is dependent on type and capabilities of
test equipment and not the software component that
is interfacing to it.
In either system additional programming and
development is most likely necessary.

Many companies use a bolt-on statistical package


like NWA (Northwest Analytics).
SAP supports dumping of data to statistical
packages with the QM-STI. Update of statistical tools
within SAP, e.g. via QM Evaluation Cockpit.
LIMS is sometimes still seen to be stronger option,
although SAP is typically workable.

2011 SAP AG. All rights reserved.

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Today: Common and Central Approach to LIMS


Enterprise LIMS
To overcome the challenges of the traditional LIMS in terms of
Isolated platforms
Lack of common source and visibility
Redundancy of master data
Numerous interfaces
Lack of traceability etc.
Reduction of
interfaces
and complexity of
infrastructure => cost
reduction!

Compliance with
Regulations & Industry
Standards via general
and uniform approach

2011 SAP AG. All rights reserved.

Common Audit
Trail and overall
traceability

Reduction of data
redundancy and
visibility of
information

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Evaluation of Typical LIMS


Functionality and SAP's Solution

Typical Requirements Towards a LIMS

Sample management - flexible

Copy results from former tests

Bar codes

Change control and audit trail

Stability studies

Digital signatures

Supporting Laboratory processes

Flexible reporting capabilities

Worklist of their open inspections for lab


technician

Detailed corrective and preventive actions


process for a detected issue

Detailed documentation of results

Certificates handling

Different ways of results recording (e.g.


across samples or inspection lots)

Comprehensive authorization concept

Calculated results

Calibration of test equipments

Interfacing with test equipments for direct


upload of results
Document management

2011 SAP AG. All rights reserved.

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QM with SAP: A Comprehensive & Integrated Solution for


All Industries
QM with SAP ERP can be applied as laboratory information and
management system (LIMS) or as Computer Aided Quality (CAQ) System.

Machinery & Construction

Chemicals

Consumer Products High Tech

Automotive

Pharmaceuticals

Advantages compared to separate CAQ/LIMS systems:


High integration into other SAP business processes
No redundant master data
5600 customers
No interfaces
and 200
references
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Examples
Using QM with SAP as LIMS

Handling of Samples, Identification of Samples


Inspection Lots and Physical Samples in SAP

Inspection
Lot

Lab 1

Lab 2

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Lab 3

Different types of physical samples: primary,


pooled and reserve samples.
Results documentation for each physical
sample.
Sample records created with the inspection lot
or later.
Planned and unplanned physical samples.
Trigger additional inspection for existing sample.
Bundling of samples via physical sample
drawing.
Dispatch of different samples to different labs.
Printing of barcode labels for further
identification.

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Sample Management at Goods Receipt Inspection

Physical Sample Labels

with barcodes for all physical


sample types

New Sample Drawing Instruction


with information about distribution
of samples

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Flexible Selection of Specifications During Inspection Lot


Creation
After assignment of
inspection plan manual
sample calculation to
trigger flexible selection of
characteristics and
specifications.

Benefits:
For flexible adjustment of specification data before starting the actual test!
E.g. for service-based inspections.
Also applicable for results recording (adjustment of specs).
2011 SAP AG. All rights reserved.

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Stability Studies
GMP-Requirement: Stability test for new products
Continuous tests of durability
Research oriented tests
Bill of material

Flexible Assignment
of Specifications
First
Investigation
Inspection
Lot
manual

Initial Sample

Available Objects
Scheduling

Schedule
Strategy

3 Month

Sample at 8

Test plan 1
with
inspection
series of 3, 6,
9, ... months

Test plan 2
with
inspection
series (3, 9,
Sample at 21 12,... month)
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Inspection
Lot

6 Month
Inspection
Lot

3 Month
Inspection
Lot

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Flexibility in Triggering Laboratory processes

Planning

Scheduling
Sample
Dispatch

Planned

Test
Schedule
Inspection
Plan
Specification
Service
Entry
Inspection
Method

Unplanned

Request
Sales Order
Service Order

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Sample
Management
CapacityPlanning

Sample
Execution
Results
Recording
Validation

Billing
and CoA
Certificate
of Analysis
Invoice
(or internal
activities)
Q-DataExchange

Flexible
Specifications
Inspection
Plan
Specification
Inspection
Method

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Calculated Results

Idea of Input Processing:


Translation of entered results (average and single values) according to defined rules.

SAP Solution:
Provided via an exchangeable program-part (Business Add-In)
Fields that can be changed: entered value, attribute, origin of results data, number
of decimal places
Entered value will be stored in the field original value.
SAP standard procedures
Output according to input
Output of significant digits
Input date

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Input Processing: Example

Procedure: Date

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Calibration
Covered via Integration of QM and PM Functionality
Planning

Scheduling

Maintenance
task list
Equipment,
Functional
location
Maintenance
plan

Order
Release

Release !

Inspection
lot creation

Insp.lot

Calibration
inspection

Insp.lot

PM order
CS order

Including
Confirmation of used equipment => tracking of equipment (where used)
Update of equipment status incl. measurement info
Test before and after calibration
Audit trail and digital signature
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Results Copy Functionality


Option 1: Copy results automatically
during sample calculation
Option 2: Copy results automatically
during results recording
Option 3: Manual selection of an
inspection lot during results recording

Transfer Log
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Supporting regulatory compliance


Digital Signature in QM
Sample Drawing
Results Recording
Usage Decision
Quality Notifications
Multiple Signature Methods
Signature Strategies

Electronic Batch Record (EBR)


Deviation Analysis
Audit Trail Functionality
Cross-Application

Change Management
Batch Traceability
Batch Information Cockpit
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Flexible Reporting Capabilities


QM Cockpit for Evaluations
Ad-hoc evaluations of quality notifications and results
Specific graphics types:
Pareto Chart
Scatter Plot
Control Chart

Queries & figures via SAP NetWeaver BI


Analyze data from
Notifications / Tasks
Audits
inspection lots
Predefined queries

Supplier evaluation
Quality of purchased parts
Quality Scores
Audit Results
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QM Evaluation Cockpit
Two Examples

Pareto Chart to show


defect frequencies

Comparison of
characteristics

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Quality Notifications
Problem and Complaint Management CAPA Process

Problem and
Complaint
Management

Workflow
Classification
Quality-related costs
Follow-up actions with standard examples
Solution Database
Web-based entry via SAP MII

Corrective and
Preventive Action

Status Management
Tracking and Monitoring
Use of Catalogs

Quality
Analytics

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QM Evaluation cockpit for ad-hoc reporting


Predefined queries and key figures in SAP NetWeaver BI
Supplier evaluation
Full-text search

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Certificate Process
Individual certificate profiles
Content and scope (characteristics)
Data origin (across supply chain)

Outbound certificates
For production batches
For deliveries (multi-level)

Inbound certificates from suppliers


Electronic quality data exchange options
Integrated with customer/supplier data
Archiving

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Test Equipment Interfacing


Possible Ways with SAP ERP
QM with SAP ERP used as Enterprise LIMS
PCo

(Plant Connectivity)

Connectivity
Framework for
external devices
(PCo)
Data Agents

Steinwald interface box;


Simple Test Equipments

QM-IDI
Interface

Enterprise Service
(SOA)

Complementary
Partner Product
(no full-blown LIMS,
e.g. IDOS,
Dr. Eilebrecht SSE *)

ES Bundles
Integration of QM
Systems (IQM) and
Easy Inspection
Planning (EIP)

Direct integration,
e.g. with CDS

Flexible Web
Services

Complex Test Equipment


(e.g. HPLC)

QM Data Exchange with


consumer applications (e.g.
SAP MII, 3rd party systems)

MDS Manufacturing Data Services / CDS Chromatography Data Systems


HPLC High Performance Liquid Chromatography / MII SAP Manufacturing Integration and Intelligence
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Simple Data
Transfer

RS232 serial interface


File transfer
Interface Boxes
(e.g. Steinwald)
Keyboard Wedges

Simple Test Equipments


(e.g. balances, colorimeter
etc.

* IDOS and Dr. Eilebrecht SSE partners for QC interfacing

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Latest Updates of SAP QM

SAP Developments Towards LIMS in the Latest Releases


SAP Enterprise (4.7)
Stability Study
Flexible inspection specifications
Input Processing
Copy Inspection Results
Analysis of stability studies via
SAP NetWeaver BI

SAP ERP 6.0


Multiple Specifications
Operation Completion
QM Evaluation Cockpit

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EhP3 for SAP ERP 6.0


Dual-control principle for results
recording
Enhanced digital signature also for
Quality Notifications, multilevel
signature strategies
Extended QM Cockpit for Evaluations:
Quality Notification and components
Extended Search for Quality Notifications

EhP4 for SAP ERP 6.0


Enhanced Quality Notifications
Documentation of issues
Information exchange
Analysis of issues

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Summary and Outlook

Typical Requirements Towards a LIMS

Sample management - flexible

Copy results from former tests

Bar codes

Change control and audit trail

Stability studies

Digital signatures

Supporting Laboratory processes

Flexible reporting capabilities

Worklist of their open inspections for lab


technician

Detailed corrective and preventive actions


process for a detected issue

Detailed documentation of results

Certificates handling

Different ways of results recording (e.g.


across samples or inspection lots)

Comprehensive authorization concept

Calculated results

Calibration of test equipments

Interfacing with test equipments for direct


upload of results
Document management

SAP can!
2011 SAP AG. All rights reserved.

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Benefits of Using QM with SAP


Along the entire supply chain
Draw, prepare
and distribute
samples

Trigger
Inspection

Capture results
and issues

Decide on Usage

Re-use master data

Digital signature

Processing configuration

Digital signature

Different inspection
types (goods
movement, order
release, scheduling,
stability study,
manual )

Preplanning of sample
drawing

Digital signature

Release /block batch

Adjustment of specifications

Multiple specifications

Input processing

Follow-up actions

Results copy

Billing of analysis

Bundling of samples

Operation completion

Direct link to other


processes and data

Multiple specifications

Flexible inspections

Trigger CAPA
Draw additional samples

Complaints
Retest of reserved samples
Flexible evaluation of results
Copy results

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SAP Provides Enterprise LIMS plus Integration


Supporting Total Quality Management
Workflow,
Authorization
Concept
QM Manual

Human
Resources

Inventory Mgmt.
Batch Mgmt.
Change Handling
CAPA
Data Warehouse
Document Mgmt.

Logistics

Quality- Related
Costs
Revenues

Finance &
Controlling

Test Equipment
Management
Calibration,
Planning &
Execution

Enterprise
Asset
Management

Enterprise Quality Management


Research &
Development

Procurement

Stability Study

Inspection Planning

Flexible Specifications

Supplier Release & CoA

Recipe Management

Goods Receipt
Inspection

Advanced Product
Quality Planning
(APQP/FMEA)

2011 SAP AG. All rights reserved.

Production

In-/Post-Process Control
SPC-Statistical Process Control
Interfaces for Measurement
Devices
Deviation Management

Sample Management

Electronic Batch Record

Audit Management

Integration to SAP MII

Sales

Certificate of Analysis
(CoA)
Quality Data Exchange
Billing of Analysis

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Business Reasons to Replace LIMS with SAP QM


5 Key Points to Take Home
Integration
Increased need for tight integration between quality, manufacturing and R&D throughout
supply chain.

Cost and Process Efficiency


Increased cost pressures are forcing companies to track quality costs more efficiently.
Elimination of interfaces to 3rd party systems (i.e. effort for support & upgrade & license costs).

Enterprise LIMS Approach


Testing is Moving out of Laboratories - Products are tested more on front end than later.
Global approach for standardized testing practices to enforce consistent product quality.
Also adaptable for different business scenarios.

Transparency and Visibility


Increasing need for quick product recall situations requiring tight traceability.
Consistent, transparent and redundancy-free data.

Increasing Issues with LIMS providers


Stability of LIMS providers.

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More than 200 Reference Customers for QM wit SAP


Examples
Automotive

Chemicals

Consumer Products

BMW Manufacturing Corporation


USA

BASF
BASFAG
AG
Germany

Arla
ArlaFoods
FoodsAmba
Amba
Denmark

Brose Fahrzeugteile GmbH & Co. KG


Germany

Clariant
Germany

Michael Foods, Inc.


USA

Continental Teves AG & Co. oHG


Germany

Degussa Roehm GmbH


Germany

McCormick & Company Inc.


USA

Grammer AG
Germany

Dow Corning Corp.


USA

Dr. August Oetker


Germany

ZF Passau GmbH
Germany

DSM Fine Chemicals


Austria

IM&C

High Tech

Life Sciences

Andreas Stihl AG & Co.


Germany

3M Espe
Germany

Abbott Laboratories
USA

Balluff GmbH
Germany

Qimonda
Germany

Merckle ratiopharm GmbH


Germany

Briggs & Stratton Corporation


USA

Molex Incorporated
USA

Roche Diagnostics
Germany

Kaeser Kompressoren GmbH


Germany

Roche Diagnostics Corp.


USA

Sanofi - Aventis Deutschland GmbH


Germany

August Rggeberg GmbH & Co. KG


Germany
2011 SAP AG. All rights reserved.

Solvay Pharmaceuticals B.V.


Netherlands
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Information on Quality Management with SAP


In the SAP Service Marketplace

Brochures
Quality Management with SAP ERP
SAP QM as Enterprise LIMS
Stability Studies with SAP ERP
Success Story with SPIMACO
Further brochures on QM and more

https://service.sap.com/qm
Media Library
(requires login credentials)

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Thank You!
Session Code: 2706

Contact information:
Mike Krug
QMS Inc.
mkrug@qmsinc.com

Beate Lindqvist, Product Owner QM


SAP AG, Germany
beate.lindqvist@sap.com

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