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