Seminar

SAP: Validation and
GMP Compliance

SAP: Validation and GMP Compliance

SAP S/4HANA has been launched in 2015 as the new intelligent ERP system. The software is available as cloud edition and as on-prem edition. SAP S/4HANA is being called the biggest update to its ERP system in over two decades. Together with the move to in-memory database SAP HANA a new user interface (SAP Fiori) was introduced. The mainstream maintenance for the predecessor products will end in 2025. Due to this time line a lot of SAP customers have already started the transformation journey to SAP S/4HANA or at minimum have initiated a pre-project.
How will all these technical and functional changes in the surrounding of SAP S/4HANA (user interface, in-memory database, different deployment types) impact the validation approach and the validation scope?
This ECA course will provide comprehensive knowledge about how to validate SAP S/4HANA for new SAP customers as well as for installed base customers who are planning a system conversion. Expect two days full of shared best practices for the validation of SAP S/4HANA considering recent regulatory requirements like EU GMP Guide Annex 11, GAMP 5 and 21 CFR Part 11.

Objectives

You will learn:

  • How to validate SAP S/4HANA in a GMP environment
  • Which specific requirements should be taken into consideration in the CSV process?
  • How to use SAP Solution Manager 7.2 as a validation platform?
  • What problems could arise during validation and how to solve them?
  • How to maintain the validated state of SAP with the least efforts?

Date:

Tuesday, 12 November 2019, 09.00 h – 18.00 h
(Registration and coffee 08.30 h – 09.00 h)
Wednesday, 13 November 2019, 08.30 h – 17.00 h

Venue:

Steigenberger Hotel Berlin
Los-Angeles-Platz 1
10789 Berlin, Germany

Target Group:

This Education Course is directed at experienced employees from

  • IT & IT Service Providers
  • Quality Assurance / Quality Control
  • Production / Engineering

who have to deal with SAP S/4HANA in a healthcare environment

Further information:

Flyer and Registration Form

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