SAP: Validation and GMP Compliance

SAP: Validation and GMP Compliance

Berlin, Germany

Course No 17415

 

Costs

ECA-Member: EUR 1490,--
Non ECA Member: EUR 1690,--
EU/GMP Inspectorates: EUR 845,--
APIC Member Discount: EUR 1590,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Thilo Jania, OLYMPUS EUROPA
Christian Kunath, Santhera Pharmaceuticals
Dennis Leblang, DHC Dr. Herterich and Consultants
Stefan Staub, DHC AG
Stefan Temps, DHC AG

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

Background

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.

Templates

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

Programme

Validation Approach for SAP S/4HANA On Premise
  •  Legal requirements
  •  Process oriented and risk based approach
  •  Best practices
  •  Agile vs. V-Model
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?
Case Study: Validation of SAP Cloud Products (Success Factors)
  •  Challenges and chances of the new Cloud paradigm
  •  Best Practices in validation
  •  Supplier qualification of Cloud Providers
  •  Operation of Cloud systems
  •  Ensuring Data Integrity with Cloud Products
Process Landscape and IT System Landscape
  •  Changes in SAP Product Landscape
  •  SAP System Landscapes
  •  System Landscapes for Transformation Projects
SAP Configuration Management vs. Validation Approach
  •  Implementation Approach
  •  Customizing and Development
  •  Change and Transport System
  •  SAP Release Strategy for SAP S/4HANA
  •  Validation Challenges
Using SAP Solution Manager 7.2 as a Validation Platform
  •  SolMan as Application Lifecycle Management Tool
  •  Solution Documentation & Test Management
  •  IT Service Management
  •  Change Management
  •  How can SAP Solution Manager support the S/4HANA transformation?
Case Study: Managing a 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
Transformation to SAP S/4HANA and Data Migration
  •  A strategic approach to data migration
  •  Regulatory requirements and data migration
  •  Validating the data migration
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
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
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

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