SAP: Validation and GMP Compliance

SAP: Validation and GMP Compliance

Berlin, Germany

Course No 16784


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Dr Thilo Jania, DP/O
Christian Kunath, Vifor Pharma AG
Florian Rauch, DHC Dr. Herterich and Consultants
Stefan Staub, DHC AG
Stefan Temps, DHC AG


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


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.

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.


All participants get a set of useful templates for download
  • Validation plan
  • User requirement specifications
  • Functional specifications
  • Test scripts
  • Risk assessment questions
  • Data Integrity Assessment
  • Data Migration


SAP S/4HANA – Major changes and impact on validation approach
  • S/4HANA - The new digital core
  • Major changes in system architecture
  • What does this mean for the validation approach?
Process Landscape and IT System Landscape
  • Changes in SAP Product Landscape
  • SAP System Landscapes
  • System Landscapes for Transformation Projects
Validation Approach for SAP S/4HANA on premise
  • Legal requirements
  • Process oriented and riskbased approach
  • Best practices
  • Agile vs. V-Model
Validation of SAP Cloud Products
  • Challenges and chances of the new paradigm
  • Best Practices
  • Supplier qualification of Cloud Providers
  • Operation
  • Ensuring Data Integrity with Cloud Products
SAP S/4HANA at Vifor Pharma
  • The global CSV Framework
  • Implementation and Operation of computerized Systems
  • The risk-based approach
  • Inspection experiences
SAP Configuration Management vs. Validation
  • Approach
  • Implementation Approach
  • Customizing and Development
  • Change and Transport System
  • SAP Release Strategy for SAP S/4HANA
  • Validation Challenges
Insights from the Pharma Validation Group (PVG)
  • PVG: Tasks, Objectives, Members
  • Quo Vadis SAP? The journey from Software Manufacturer to Service Provider
  • SAP Audit - change in focus: Frequency and content on the test bench
Using SAP Solution Manager 7.2 as a Validation platform (incl. live demo)
  • SolMan as Application Lifecycle Management Tool
  • Incident Management
  • Change Management
  • How can SAP Solution Manager support the S/4HANA transformation?
Managing an European SAP program in a validated environment (Olympus Surgical Technologies Europe)
  • Project Set-up at Olympus
  • Risk based approach
  • Experiences / Success factors
  • Further implications for the strategic IT-landscape
Intelligent ERP: Artificial Intelligence / Machine Learning and GxP Compliance
  • How can AI / ML support future processes
  • Impact on system design
  • How to handle AI / ML during system validation
Data Integrity
  • Regulatory Requirements
  • Data Integrity Assessment
  • Data Governance System
SAP Audit Trail in SAP S/4HANA
  • Audit Trail functionality in SAP S/4HANA
  • Review of Audit Trail
  • Audit Trail in CSV documentation
Transformation to SAP S/4HANA and Data Migration
  • A strategic approach to data migration
  • Regulatory requirements and data migration
  • Validating the data migration

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