Replacing LIMS Systems with SAP QM

ASUG Annual Conference May 2011

Mike Krug, QMS Inc., Beate Lindqvist, SAP AG
May 2011
Public
Session Code: 2706
2011 SAP AG. All rights reserved. 2 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. 3 Public
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
History of LIMS and SAP QM
2011 SAP AG. All rights reserved. 5 Public
History of LIMS & SAP QM
LIMS Systems
Laboratory Information Management System
(LIMS).
Developed for Laboratories, specifically
around testing.
Typically found in pharmaceutical and other
process industries.
Historically incorporating more Quality
Control capabilities along with reporting and
statistical analysis, e.g.
Sample Management
Calibrations
SPC
Initially was the Hands Down choice for
laboratories that needed to do a lot (>1
million) samples per year.
SAP QM
Available since the R/3 3.0 Days.
Initially offered Quality Assurance functions.
Was enhanced significantly in 4.0b
(calibrations), 4.7 (stability studies), 5.0
(multiple specs ).
Strength was around COA generation
because of its tight integration with other
modules (SD, MM).
QM-IDI (QM Instrument Data Interface) to
connect SAP with the LIMS systems.
2011 SAP AG. All rights reserved. 6 Public
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
Historically: Best of Breed Approach
Combining both, LIMS & SAP QM
2011 SAP AG. All rights reserved. 7 Public
A Side-by-side Comparison LIMS vs. SAP QM
Data Entry / Usability
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.
Calibration
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
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.
Reporting / SPC
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. 8 Public
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!
Common Audit
Trail and overall
traceability
Reducti on of data
redundancy and
visibility of
information
Compliance with
Regulations & Industry
Standards via general
and uniform approach
Evaluation of Typical LIMS
Functionality and SAP's Solution
2011 SAP AG. All rights reserved. 10 Public
Typical Requirements Towards a LIMS
Sample management - flexible
Bar codes
Stability studies
Supporting Laboratory processes
Worklist of their open inspections for lab
technician
Detailed documentation of results
Different ways of results recording (e.g.
across samples or inspection lots)
Calculated results
Interfacing with test equipments for direct
upload of results
Document management
Copy results from former tests
Change control and audit trail
Digital signatures
Flexible reporting capabilities
Detailed corrective and preventive actions
process for a detected issue
Certificates handling
Comprehensive authorization concept
Calibration of test equipments

2011 SAP AG. All rights reserved. 11 Public
QM wi th SAP: A Comprehensive & Integrated Solution for
All Industries
Chemicals Consumer Products High Tech Automotive Pharmaceuticals
QM with SAP ERP can be applied as laboratory information and
management system (LIMS) or as Computer Aided Quality (CAQ) System.
Machi nery & Constructi on
Advant ages c ompar ed t o separ at e CAQ/LI MS syst ems:
High integration into other SAP business processes
No redundant master data
No interfaces
5600 c ust omer s
and 200
r ef er enc es
Examples
Using QM with SAP as LIMS
2011 SAP AG. All rights reserved. 13 Public
Lab 3 Lab 2 Lab 1
Handling of Samples, Identification of Samples
Inspection Lots and Physical Samples in SAP
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.
Inspection
Lot
2011 SAP AG. All rights reserved. 14 Public
Sample Management at Goods Receipt Inspection
Physi c al Sampl e Label s
w i t h bar c odes f or al l physi c al
sampl e t ypes
New Sampl e Dr aw i ng I nst r uc t i on
w i t h i nf or mat i on about di st r i but i on
of sampl es
2011 SAP AG. All rights reserved. 15 Public
Flexible Selection of Specifications During Inspection Lot
Creation
Af t er assi gnment of
i nspec t i on pl an manual
sampl e c al c ul at i on t o
t r i gger f l ex i bl e sel ec t i on of
c har ac t eri st i c s and
spec i f i c at i ons.
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. 16 Public
Schedule
Strategy
Initial Sample
Test plan 1
with
inspection
series of 3, 6,
9, ... months
Test plan 2
with
inspection
series (3, 9,
12,... month)
Inspection
Lot
Inspection
Lot
Inspection
Lot
manual
Bill of material
Inspection
Lot
Sample at 21
Sample at 8
Stability Studies
GMP-Requirement: Stability test for new products
Continuous tests of durability
Research oriented tests
Avai l abl e Obj ec t s
Sc hedul i ng
Fl ex i bl e Assi gnment
of Spec i f i c at i ons
3 Month 6 Month
3 Month
First
Investigation
2011 SAP AG. All rights reserved. 17 Public
Service Entry
Request
Fl ex i bl e
Spec i f i c at i ons
Sal es Or der
Ser vi c e Or der
Flexibility in Triggering Laboratory processes
Pl anni ng Sc hedul i ng
Test
Sc hedul e
Bi l l i ng
and CoA
Sampl e
Ex ec ut i on
I nspec t i on
Pl an
Spec i f i c at i on
I nspec t i on
Met hod
I nspec t i on
Pl an
Spec i f i c at i on
I nspec t i on
Met hod
Sampl e
Management
Capac i t y-
Pl anni ng
Resul t s
Rec or di ng
Val i dat i on
Cer t i f i c at e
of Anal ysi s
I nvoi c e
(or i nt er nal
ac t i vi t i es)
Q-Dat a-
Ex c hange
Sampl e
Di spat c h
P
l
a
n
n
e
d
U
n
p
l
a
n
n
e
d
2011 SAP AG. All rights reserved. 18 Public
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
2011 SAP AG. All rights reserved. 19 Public
Input Processing: Example
Pr oc edur e: Dat e
2011 SAP AG. All rights reserved. 20 Public
Calibration
Covered via Integration of QM and PM Functionality
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
Planning Scheduling
Calibration
inspection
Inspection
lot creation
Order
Release
Release !
Maintenance
task list
Equipment,
Functional
location
Maintenance
plan
Insp.lot Insp.lot
PM order
CS order
2011 SAP AG. All rights reserved. 21 Public
Results Copy Functionality
Opt i on 1: Copy results automatically
during sample calculation
Opt i on 2: Copy results automatically
during results recording
Transfer Log
Opt i on 3: Manual selection of an
inspection lot during results recording
2011 SAP AG. All rights reserved. 22 Public
Supporting regulatory compl iance
Di gi t al Si gnat ur e i n QM
Sample Drawing
Results Recording
Usage Decision
Quality Notifications
Multiple Signature Methods
Signature Strategies
El ec t r oni c Bat ch Rec or d (EBR)
Devi at i on Anal ysi s
Audi t Tr ai l Func t i onal i t y
Cross-Application
Change Management
Bat ch Tr ac eabi l i t y
Bat ch I nf or mat i on Cock pi t
2011 SAP AG. All rights reserved. 23 Public
Flexible Reporting Capabilities
Ad-hoc evaluations of quality notifications and results
Specific graphics types:
Pareto Chart
Scatter Plot
Control Chart
QM Coc k pi t f or Eval uat i ons
Analyze data from
Notifications / Tasks
Audits
inspection lots
Predefined queries
Quer i es & f i gur es vi a SAP Net Weaver BI
Quality of purchased parts
Quality Scores
Audit Results
Suppl i er eval uat i on
2011 SAP AG. All rights reserved. 24 Public
QM Evaluation Cockpit
Two Examples
Pareto Chart to show
defect frequencies
Comparison of
characteristics
2011 SAP AG. All rights reserved. 25 Public
Quality Notifications
Problem and Complaint Management CAPA Process
Status Management
Tracking and Monitoring
Use of Catalogs
Workflow
Classification
Quality-related costs
Follow-up actions with standard examples
Solution Database
Web-based entry via SAP MII
Problem and
Complaint
Management
Corrective and
Preventive Action
QM Evaluation cockpit for ad-hoc reporting
Predefined queries and key figures in SAP NetWeaver BI
Supplier evaluation
Full-text search
Quality
Analytics
2011 SAP AG. All rights reserved. 26 Public
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
Certificate Process
2011 SAP AG. All rights reserved. 27 Public
Test Equipment Interfacing
Possible Ways with SAP ERP
MDS Manufacturing Data Services / CDS Chromatography Data Systems
HPLC High Performance Liquid Chromatography / MII SAP Manufacturing Integration and Intelligence * IDOS and Dr. Eilebrecht SSE partners for QC interfacing
Si mple Test Equipments
(e.g. balances, colorimeter
etc.
QM Data Exchange wi th
consumer applicati ons (e.g.
SAP MII, 3rd party systems)
Complex Test Equipment
(e.g. HPLC)
Steinwald interface box;
Si mple Test Equipments
QM w i t h SAP ERP used as Ent er pr i se LI MS
PCo
(Pl ant Connec t i vi t y)
QM-I DI
I nt er f ac e
Ent er pr i se Servi c e
(SOA)
Si mpl e Dat a
Transf er
Connectivity
Framework for
external devices
(PCo)
Data Agents
Complementary
Partner Product
(no full-blown LIMS,
e.g. IDOS,
Dr. Eilebrecht SSE *)
Direct integration,
e.g. with CDS
ES Bundles
Integration of QM
Systems (IQM) and
Easy Inspection
Planning (EIP)
Flexible Web
Services
RS232 serial interface
File transfer
Interface Boxes
(e.g. Steinwald)
Keyboard Wedges
Latest Updates of SAP QM
2011 SAP AG. All rights reserved. 29 Public
SAP Developments Towards LIMS in the Latest Releases
SAP Ent er pr i se (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
EhP3 f or SAP ERP 6.0
Dual-control principle for results
recording
Enhanceddigital signature also for
Quality Notifications, multilevel
signature strategies
Extended QM Cockpit for Evaluations:
Quality Notification and components
Extended Searchfor Quality Notifications
EhP4 f or SAP ERP 6.0
EnhancedQuality Notifications
Documentation of issues
Information exchange
Analysis of issues
Summary and Outlook
2011 SAP AG. All rights reserved. 31 Public
Typical Requirements Towards a LIMS
Sample management - flexible
Bar codes
Stability studies
Supporting Laboratory processes
Worklist of their open inspections for lab
technician
Detailed documentation of results
Different ways of results recording (e.g.
across samples or inspection lots)
Calculated results
Interfacing with test equipments for direct
upload of results
Document management
Copy results from former tests
Change control and audit trail
Digital signatures
Flexible reporting capabilities
Detailed corrective and preventive actions
process for a detected issue
Certificates handling
Comprehensive authorization concept
Calibration of test equipments

SAP can!
2011 SAP AG. All rights reserved. 32 Public
Benefits of Usi ng QM with SAP
Along the entire supply chain
Trigger
Inspection
Draw, prepare
and distribute
samples
Capture results
and issues
Decide on Usage
Re-use master data
Different inspection
types (goods
movement, order
release, scheduling,
stability study,
manual )
Direct link to other
processes and data
Flexible inspections
Digital signature
Preplanning of sample
drawing
Bundling of samples
Processing configuration
Digital signature
Adjustment of specifications
Input processing
Results copy
Operation completion
Multiple specifications
Trigger CAPA
Draw additional samples
Digital signature
Release /block batch
Multiple specifications
Follow-up actions
Billing of analysis
Complaints
Retest of reserved samples
Flexible evaluation of results
Copy results

2011 SAP AG. All rights reserved. 33 Public

SAP Provides Enterprise LIMS plus Integration
Supporting Total Quality Management
Ent er pr i se Qual i t y Management
Human
Resour c es
Logi st i c s
Fi nanc e &
Cont r ol l i ng
Ent er pr i se
Asset
Management
Human
Resour c es
Workflow,
Authorization
Concept
QM Manual
Inventory Mgmt.
Batch Mgmt.
Change Handling
CAPA
Data Warehouse
Document Mgmt.
Quality- Related
Costs
Revenues
Test Equipment
Management
Calibration,
Planning &
Execution
Sal es Pr oduc t i on Pr oc ur ement
Resear c h &
Devel opment
Stability Study
Flexible Specifications
Recipe Management
Advanced Product
Quality Planning
(APQP/FMEA)
Inspection Planning
Supplier Release & CoA
Goods Receipt
Inspection
Sample Management
Audit Management
In-/Post-Process Control
SPC-Statistical Process Control
Interfaces for Measurement
Devices
Deviation Management
Electronic Batch Record
Integration to SAP MII
Certificate of Analysis
(CoA)
Quality Data Exchange
Billing of Analysis
2011 SAP AG. All rights reserved. 34 Public
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 3
rd
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.
2011 SAP AG. All rights reserved. 35 Public
More than 200 Reference Customers for QM wit SAP
Examples
Solvay Pharmaceuticals B.V.
Netherlands
August Rggeberg GmbH & Co. KG
Germany
Sanofi - Aventis Deutschland GmbH
Germany
Roche Diagnostics Corp.
USA
Kaeser Kompressoren GmbH
Germany
Roche Diagnostics
Germany
Molex Incorporated
USA
Briggs & Stratton Corporation
USA
Merckle ratiopharm GmbH
Germany
Qimonda
Germany
Balluff GmbH
Germany
Abbott Laboratories
USA
3M Espe
Germany
Andreas Stihl AG & Co.
Germany
DSM Fine Chemicals
Austria
ZF Passau GmbH
Germany
Dr. August Oetker
Germany
Dow Corning Corp.
USA
Grammer AG
Germany
McCormick & Company Inc.
USA
Degussa Roehm GmbH
Germany
Continental Teves AG & Co. oHG
Germany
Michael Foods, Inc.
USA
Clariant
Germany
Brose Fahrzeugteile GmbH & Co. KG
Germany
Arla Foods Amba
Denmark
BASF AG
Germany
BMW Manufacturing Corporation
USA
Aut omot i ve Chemi c al s Consumer Pr oduc t s
I M& C Hi gh Tec h
Li f e Sc i enc es

Arla Foods Amba

Denmark
BASF AG
Germany
2011 SAP AG. All rights reserved. 36 Public
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)
Thank You!
Contact information:
Mike Krug
QMS Inc.
mkrug@qmsinc.com
Beate Lindqvist, Product Owner QM
SAP AG, Germany
beate.lindqvist@sap.com
Session Code: 2706
2011 SAP AG. All rights reserved. 38 Public
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