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Annex 11 - Computerised Systems

Organisations:
EMA
Topics:
Qualification & Validation Software

Version Timeline

Chronological release history

9714

Version milestone

Publication Date

12 Jun 2025

Effective Date

Not specified

Main updates: Security, Audit Trails, Identity and Access Management, Alarms, Supplier and Service Management, Qualification and validation, Periodic review, Electronic signatures, Handling of data and backups.

SANCO/C8/AM/sl/ares(2010)1064599

Version milestone

Publication Date

30 Jun 2011

Effective Date

30 Jun 2011