Applicability
Computerised systems used as part of applicable EU GMP regulated activities.
What Changed
This record distinguishes the operative Annex 11 from the later consultation draft.
What Did Not Change
The January 2011 revision remains the published operative annex until a final replacement is adopted.
Practical Impact
Continue addressing lifecycle risk management, suppliers, data integrity, security, incidents, business continuity, and periodic evaluation.
Actions to Consider
Assess against the operative text and monitor the Commission source for a final replacement.
Primary Source
Revision history
Version 1.2 · 12 September 2026: Terminology and source fields standardized for Version 32.