EU Annex 11

Definition

EU Annex 11 is the annex to the European Union's GMP guidelines that governs computerized systems used in GMP-regulated activities. It's the European counterpart to the FDA's 21 CFR Part 11, covering requirements such as validation, data integrity, security, and audit trails for electronic systems including EBR platforms.

Benefits

Designing EBR systems to meet both Annex 11 and Part 11 requirements simultaneously, rather than treating them as separate compliance exercises, streamlines validation for companies manufacturing or distributing across both US and EU markets.

Use Case

A contract manufacturer supplying both US and EU markets validates its EBR system against a combined requirements matrix covering both Part 11 and Annex 11, rather than running two separate, duplicative validation efforts for the same system.

Frequently Asked Questions (FAQ)

Related Terms

• 21 CFR Part 11
• GMP (Good Manufacturing Practice)
• Data Integrity