Academy · Testing & Quality · 400 Expert
Audit-Ready Sign-Off: Validation Testing for Regulated SAP Systems
Covers testing and sign-off for SAP systems subject to financial controls (for example SOX) and life-sciences regulations (GxP). Explains risk-based validation and computer software assurance, traceability from requirement to signed evidence, evidence integrity, and how recurring cloud releases are handled in regulated environments, ending with a simulated auditor walkthrough.
- 75 minutes
- 6 lessons + quiz
- Test Lead / Test Manager, Program / PMO Lead, Security & GRC Specialist
What you’ll be able to do
- Explain the purpose of computerized system validation and risk-based assurance
- Identify SAP processes and controls in scope for financial or GxP validation
- Design traceability from requirement to test to evidence to sign-off
- Define evidence standards that survive audit
- Plan validation of recurring cloud releases with a risk-based approach
Sources and further reading
- Computer Software Assurance for Production and Quality Management System Software · U.S. Food and Drug Administration
- 21 CFR Part 11 - Electronic Records; Electronic Signatures · eCFR (U.S. National Archives)
- EudraLex Volume 4, Annex 11: Computerised Systems · European Commission
- GAMP 5 Guide, 2nd Edition · ISPE
- Internal Control (Internal Control - Integrated Framework) · COSO
- Planning and Executing Testing (lesson, Implementing with SAP Cloud ALM) · SAP Learning
- Introducing the Test Automation Tool (lesson) · SAP Learning