Applicability
Horizon-scanning material for computerized systems and AI in applicable GMP manufacturing contexts.
What Changed
The drafts proposed updated lifecycle, supplier, data-integrity, security, AI model, performance, monitoring, and human-review expectations.
What Did Not Change
Consultation text is not final binding or operative guidance. Existing applicable requirements continue until formally replaced.
Practical Impact
Use the drafts to identify potential readiness questions without representing them as current law.
Actions to Consider
Map potentially affected controls and monitor official adoption. Label any resulting action as readiness work or professional interpretation.
Primary Source
Revision history
Version 1.2 · 12 September 2026: Terminology and source fields standardized for Version 32.