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

Qvents compilation of regulatory guidance’s on Computer System Validation, Electronic Data Review from USFDA, EMA, PIC-S. Access all guidelines on the topic – from USFDA 21 CFR Part 11 requirements, Questions and Answers, Document heavy CSV approach, Risk based frame work of CSA. Revised EC Annex 11 with focus on cybersecurity controls and EC Annex 22 focus on AI systems

• 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
• USFDA: Computer Software Assurance for Production and Quality System Software (September 2025)
• 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)