21 CFR 11: Risks of Noncompliance

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?

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