21 CFR 11: Risks of Noncompliance


This paper addresses major concerns about interpretation of the regulation and the ensuing release of "Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application" in August 2003. It also explains FDA's clarification of two points: (1) FDA intends to interpret Part 11 narrowly; and (2) the agency is taking a risk-based approach in enforcing compliance to some of the technical controls for Part 11, such as validation, audit trails, record retention and record copying.

FDA is currently re-examining 21 CFR Part 11, the landmark regulation that made electronic records and signatures as valid as paper records and handwritten signatures. The focus of this scrutiny is the scope of Part 11's interpretation.

The agency was prompted to take a closer look at Part 11 because of concerns that some interpretations would: "(1) unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA's stated intent in issuing the rule, (2) significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted, and (3) discourage innovation and technological advances without providing a significant public health benefit."

This period of re-examination is a time of uncertainty for many pharmaceuticals, biotechnology, medical device, and other industries regulated by the FDA. How should they interpret Part 11 in the interim?