AI in GMP Environments: Validating Machine Learning Models for Quality Decisions

Summary

Machine learning is moving into visual inspection and deviation triage. This paper explains how to validate models, monitor drift and keep humans accountable for GMP decisions.

Key takeaways

1. 01Risk-based validation for ML models
2. 02Monitoring model drift after go-live
3. 03Where humans must stay in the loop
4. 04Documentation inspectors will ask for

Written for

• IT/OT leads
• Validation managers
• QA compliance