SAP: Validation and GMP Compliance
Im Auftrag der ECA Academy

SAP: Validation and GMP Compliance Im Auftrag der ECA Academy

Berlin, Germany

Seminar Nr. 16784


Kosten

Die Veranstaltung hat bereits stattgefunden. Suchen Sie nach Wiederholungsterminen und weiteren, themenbezogenen Seminaren auf der Seite GMP Seminare/-Konferenzen nach Thema.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

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

Zielsetzung

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

Hintergrund

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.

Zielgruppe

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

Programm

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
LIVE DEMO
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
LIVE DEMO
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

Zurück

GMP Seminare nach Thema

Cookies helfen uns bei der Bereitstellung unserer Dienste. Durch die Nutzung unserer Dienste erklären Sie sich damit einverstanden, dass wir Cookies setzen. Weitere Informationen

OK