Free Whitepaper
GAMP 5 AI Gap Report: 6 Common Failures
The six most common GAMP 5 AI implementation failures seen in QA assessments — with EU AI Act High Risk classification implications and the 8-area maturity model.
What This Whitepaper Covers
Key Contents
- Failure 1: Acceptance criteria defined after testing
- Failure 2: No data lineage documentation
- Failure 3: Missing model version control
- Failure 4: No ongoing drift monitoring programme
- Failure 5: Unqualified training data sources
- Failure 6: No AI-specific change control procedure
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