21 CFR Part 11 in the European Union
Interaction between Part 11 and EudraLex Annex 11, and how a modern EDC covers both.
Annex 11 as European equivalent
EudraLex Vol. 4 Annex 11 governs computerized systems in GxP. Requirements are functionally equivalent to Part 11: audit trail, validation, access controls, integrity.
Since CTR (EU) 536/2014 and the CTIS portal, electronic traceability requirements are harmonized across the EU. Meeting Part 11 is effectively meeting Annex 11.
When each applies
- •Part 11 only: FDA-bound without European authorization
- •Annex 11 only: European study without FDA submission intent
- •Both: multinational with FDA + EMA authorization (most common)
Dual coverage
- ✓Audit trail meets Annex 11 cl. 9 and Part 11 §11.10(e)
- ✓System validation applicable to both frameworks
- ✓Dual-component e-signature equivalent to both
- ✓EU residency available on Institutional
FAQ
Does one validation cover both Part 11 and Annex 11?
Functionally yes. The sponsor may request framework-specific documentation but underlying tests are the same.
Need specific documentation?
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