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