History of 21 CFR Part 11

March 25, 2008

The FDA has required pharmaceutical, biotech, and medical device companies to validate their computerized systems since the mid-1980’s under various current good manufacturing practice (“cGMP”) regulations.  The validation of computerized systems in FDA regulated industries has been evolving ever since.  However, technology was outgrowing the existing regulations. These regulations could not accommodate paperless record systems.  The old regulations kept industry from realizing the advances in efficiency, accuracy, and productivity that new technologies were allowing.  In 1991, members of the pharmaceutical industry met with the agency to determine how they could accommodate paperless record systems.  The ultimate result of this action was 21 CFR Part 11 (“Part 11”), which became effective on August 20, 1997.

There was an official grace period of five months, and there are no grandfather provisions in the regulation.   The current regulatory environment is one of ever broadening interpretation of federal law and harsher penalties by the FDA.  On November 2, 1999, Abbott Laboratories announced it had reached an agreement with the FDA to enter into a consent decree.  Under the terms of the consent decree, Abbott Laboratories agreed to a $100 million payment to the U.S. Government.  This record FDA penalty seems to have signaled the start of increased regulatory pressure being applied by the FDA to the pharmaceutical industry.  Since the record Abbott fine, Schering-Plough, Eli Lilly, and Pharmacia & Upjohn have all recently been issued harsh warnings by the FDA.

Source: FDA Validation

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About 21 CFR Part 11

March 25, 2008

The pharmaceutical, biotech, and medical device industries have become dependent on computerized systems for every aspect of a drug’s lifecycle.  Clinical trials are managed using software; New Drug Applications are submitted to the FDA electronically; laboratory assays on a drug’s efficacy are performed using computerized instrumentation; and critical parameters in the drug’s manufacturing process such as temperature and pH are controlled using automated systems.  Labeling, adverse reaction reporting, consumer complaints, and pharmacy controls also depend on various computer systems working perfectly.  All these systems now fall under the jurisdiction of 21 CFR Part 11. Source: FDA Validation