paperless lab academy - sap qm - final
TRANSCRIPT
Is SAP QM Able to Consolidate LIMS in a Regulated Pharma Environment?
LABVISORY
Thomas Wolff, LABVISORY UG (haftungsbeschränkt)
Paperless Lab Academy: Manage the Laboratory Change ProcessApril 14th, 2015; Barcelona
Contents
1. Consolidation Hypothesis
2. Case Study
2.1. Is SAP QM Able to Handle Stability Studies?
2.2. Is SAP QM Able to Handle Environmental Monitoring?
2.3. Is SAP QM Able to Integrate EmpowerTM 3 Seamlessly?
3. Validation and Implementation Approach
4. Conclusion and Recommendation
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 2
Consolidation Hypothesis – The Evolution of Best-of-Breed Approaches
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 3
2000 2015
Electronic Lab NotebookScientific Data CollectionStatistical Process ControlAdvanced Test Equip. IntegrationReagent ManagementMaster Data RepositoryReportingDocument ManagementResults RecordingSample ManagementEnvironmental MonitoringStability StudiesTest Equipment CalibrationCOA, COCFinal Release SAP R/3
LIMS
Trending Tool, SDMS, ELN
SAP ECC 6.0
Trending Tool, SDMS, ELN
Typical QA/QC Functions:
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 4
Case Study
Client: Global pharmaceutical company with a revenue exceeding US $5 billion per annum
Objectives: Global process harmonization and consolidationof IT infrastructures
Solution: Global SAP template built with local deployments and replacement oflegacy LIMS (QA/QC) with SAP QM
Results: Successful deployments and legacy LIMS (QA/QC) replacements
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 5
Is SAP QM able to handle Stability Studies?
Is SAP QM Able to Handle Stability Studies?
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 6
Overview: Stability Studies are part of SAP Best Practices for Pharmaceuticals, based on SAP QM functions, and fully integrated into other SAP components like Materials Management (MM) and Plant Maintenance (PM).
High Level Process Flow:
Compliance with 21 CFR Part 11 / Annex 11:• Electronic signatures with signature strategies (e.g. 4 eye principle) are available for all relevant master and transact. data.• Electronic records such as change master records, table logging, and change documents satisfy full audit trail requirement. • Date and time stamps for electronic records and electronic signatures are recorded in the background.
Lab Automation: • Barcodes have been used on sample labels and inspection instructions to automate the laboratory processes.• E.g. when receiving samples in the laboratory, the label will be scanned, which triggers an automated status change and printout of the inspection instruction.
The Solution: Out of the box, no customer-specific developments were required for the core stability study process. Othersuccess stories for SAP stability studies are available on the internet (e.g. Biotest AG).
Create stability
study
Physical samplemgmt.
Create initial
insp. lot
Results rec. and usage decision
Specific storage
conditions
Testing schedule
mgmt.
Print storage list, maintain storage data
Define start date
Dead-line
monit.
Re-port-ing
Sample goods issue, completion
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 7
Is SAP QM able to handle Environmental Monitoring?
Is SAP QM Able to Handle Environmental Monitoring?
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 8
Overview: The Environmental Monitoring process can be implemented with the standard SAP calibration process using SAP QM and SAP PM functions.
High Level Process Flow:
Compliances with 21 CFR Part 11 / Annex 11:Same as for stability studies. All compliance-relevant features are available in SAP and accepted by public authorities.
Lab Automation: Barcoding, automated printouts and status changes
The Solution: The standard SAP calibration management process is used for environmental monitoring. Activation of sample management features where implemented with limited developments. Process is based on standard SAP QM and PM functions.
Master data maintenance
Scheduling of monitoring
plan
Automated monit. order
creation
Release of monitoring
order
Automatedinspection
lot creation
Sample management
Result rec. and usage decision
Reporting
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 9
Is SAP QM able to integrate EmpowerTM 3 seamlessly?
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 10
Advanced Instrument
EmpowerTM 3
SAP QM, ECC 6.0/ SAP PI
?Is SAP QM Capable to Integrate EmpowerTM 3 Seamlessly?
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 11
Advanced Instrument
EmpowerTM 3
SAP QM, ECC 6.0/ SAP PI
Electronic Lab NotebookScientific Data Mgmt. System
QM-IDISeamless integration with SAP-ELN interface, certified by SAP.
ELN/SDMS is closing the gap for:
• Seamless integration of EmpowerTM 3.• Seamless integration of other
laboratory instruments, e.g. balances.• Reagents & Solvents Management• Other ELN functions
The Solution: Is currently under discussion
Is SAP QM Capable to Integrate EmpowerTM 3 Seamlessly?
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 12
Validation and implementation approach
Validation and Implementation Approach
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 13
• A validated SAP ECC 6.0 is usually up and running.
• Validation is done in accordance with existing approach.
• Implementation is done in accordance with existing approach.
• SAP QM (ECC 6.0) complies with FDA 21 CFR Part 11 / EU GMP Annex 11
-> “SAP for Life Science: Complying with Global ERES Regulations in the Life Sciences Industry”
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 14
Conclusion and recommendations.
15
Is SAP QM capable to integrate EmpowerTM 3 seamlessly?
Is SAP QM capable to handle Environmental Monitoring?
Is SAP QM capable to handle Stability Studies?
Conclusion
Efficient validation and implementation approach?
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved.
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 16
Recommendations
In conjunction with an ELN/SDMS, SAP QM is able toconsolidate LIMS in a regulated pharma environment for QA/QC laboratories.
This recommendation does not apply to R&D laboratories. These laboratories usually have very specific requirements, and the existing LIMS are usually heavily modified. There are more suitable solutions on the market than SAP QM in conjunction with ELN/SDMS in this case.
X
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 17
Thank you!Any questions?
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 18
Appendix
Best-Of-Breed Approach – approx. 10 Years ago
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 19
Best-Of-Breed Approach - Today
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 20
Contact
Thomas Wolff Fon +49 151 54711653Fax +49 3222 [email protected]
LABVISORY UG (haftungsbeschränkt)Am Hirtenturm 8D-53945 Blankenheim Germany
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 21
!
© 2015 LABVISORY UG (haftungsbeschränkt). All Rights Reserved. 22
Legal DisclosureContent and Dissemination:All contents of this document is copyright protected. Any copying, processing, modification and/or sharing of this information shall be permitted only with the express written consent of LABVISORY UG (haftungsbeschränkt). This serves only information purposes and does not contain any guarantees or warranties. Use of trademarks:SAP, SAP R/3, SAP QM, SAP PI, SAP QM-IDI, SAP QM-STI, SAP ECC 6.0 and SAP Best Practices are trademarks (™) or registered trademarks (®) of SAP AG & Co. KG in Germany and other countries. Empower 3 is a trademarks (™) of Waters Corporation, USA
Photos and Images:Stock photos primarily sourced from Fotolia and Shotshop. Photos and images may not be re-used.