paperless lab academy - sap qm - final

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


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:


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


Is SAP QM able to handle Stability Studies?

Is SAP QM Able to Handle Stability Studies?


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


Is SAP QM able to handle Environmental Monitoring?

Is SAP QM Able to Handle Environmental Monitoring?


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


Is SAP QM able to integrate EmpowerTM 3 seamlessly?


Advanced Instrument

EmpowerTM 3

SAP QM, ECC 6.0/ SAP PI

?Is SAP QM Capable to Integrate EmpowerTM 3 Seamlessly?


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?


Validation and implementation approach

Validation and Implementation Approach


• 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”


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.


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


Thank you!Any questions?


Appendix

Best-Of-Breed Approach – approx. 10 Years ago


Best-Of-Breed Approach - Today


Contact

Thomas Wolff Fon +49 151 54711653Fax +49 3222 [email protected]

LABVISORY UG (haftungsbeschränkt)Am Hirtenturm 8D-53945 Blankenheim Germany


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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.

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