[SITE NAME]

GxP rules for computerised systems, data integrity and AI — status and source in one map

Instruments

• 21 CFR Part 11: Electronic Records; Electronic Signatures
  FDA · In force
• Computer Software Assurance for Production and Quality Management System Software (FDA guidance)
  FDA · Final
• Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products (draft)
  FDA · Draft
• Data Integrity and Compliance With Drug CGMP: Questions and Answers (FDA guidance)
  FDA · Final
• EU Artificial Intelligence Act (Regulation (EU) 2024/1689), as amended
  European Union · Effective · phased
• EU GMP Annex 11 revision: Computerised Systems (draft)
  European Commission · Draft
• EU GMP Annex 11: Computerised Systems (2011)
  European Commission · In force
• EU GMP Annex 22: Artificial Intelligence (draft)
  European Commission · Draft
• EU GMP Chapter 4 revision: Documentation (draft)
  European Commission · Draft
• FDA warning letter citing over-reliance on AI in CGMP operations (Purolea Cosmetics Lab)
  FDA · Final
• Guiding Principles of Good AI Practice in Drug Development (joint FDA–EMA)
  FDA, with EMA · Final
• ICH Q9(R1): Quality Risk Management
  ICH · Final
• ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (2nd edition)
  ISPE · Industry guide
• MHRA 'GXP' Data Integrity Guidance and Definitions
  MHRA · Final
• PIC/S Guide to Good Manufacturing Practice (PE 009)
  PIC/S · In force
• PIC/S PI 041-1: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
  PIC/S · Final
• Quality Management System Regulation (21 CFR Part 820)
  FDA · In force
• WHO TRS 1033, Annex 4: Guideline on data integrity
  WHO · Final