Computer systems validation (CSV), Electronic Data Controls, Artificial Intelligence – Qvents

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Updated on July 23, 2025

Updated on July 23, 2025

USFDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
USFDA PART 11 – Electronic Records; Electronic Signatures; ECFR – 21 Part 11
USFDA: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers – Guidance for Industry
USFDA: General Principles of Software Validation; Final Guidance for Industry and FDA Staff
EC EudraLex (Europe): Annex 11: Computerised Systems – Guidance
EC EudraLex (Europe): Annex 11: Computerised Systems (Revised Draft – July 2025)
EC EudraLex (Europe): Annexure 22 – Artificial Intelligence (Draft)
EDQM – OMCL – Validation of computerised systems – Core document:
- Annexure 1 (Validation of Excel spread sheets);
- Annexure 2 (Validation of complex computerised systems).
PIC/S : Good practices for computerised Systems in regulated “GxP” environments (PIC/S Guidance)

Tags : CSV, Electronic Data Control

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