21 CFR Part 11: Data Integrity and Compliance

The Journey to 21 CFR Part 11:

  • 1991: Project launched by the U.S. Pharmaceutical Manufacturing Association
  • 1992: First edition of EU Annex 11
  • 1992: Advanced notice for public comment
  • 1994: Proposed rule published
  • 1997: Final rule published
  • 1999: Active enforcement
  • 1999: Computerized Systems Used in Clinical Trials (CSUCT)
  • 2000: Electronic records
  • 2003: “Scope and Application” guidance
  • 2004: Draft Computerized Systems Used in Clinical Trials Guidance
  • 2005: Notification of Japanese ERES guidelines
  • 2006: Quality Systems Approach to Pharmaceutical cGMP Regulations
  • 2007: Final guidance published
  • 2007: Computerized Systems Used in Clinical Trials (CSUCT) revised
  • 2011: Updated version of EU Annex 11 published (GLOBAL)
  • 2016: Data Integrity and Compliance with cGMP Guidance