21 CFR PART 11: DATA INTEGRITY & 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
    2000 – Electronic records
    1999 – Active enforcement
    1999 – Computerized Systems Used in Clinical Trials (CSUCT)
    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