SAP: Validation and GMP Compliance - Live Online

SAP: Validation and GMP Compliance - Live Online

Course No 18981

This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager". Learn more.

Note: All times mentioned are CET.

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Elke Brodbeck, DHC AG
Dr Thilo Jania, OLYMPUS EUROPA
Christian Kunath, CSL Behring
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 Live Online Training 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 Live Online Training 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.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Programme Day 1
 
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
 
Programme Day 2
 
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
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

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