FDA Part 11 Draft Validation Guidance Released

WITHDRAWN BY FDA Feb 2003 as not representative of their current thinking. FDA has released it as a draft validation Guidance on Part 11 Electronic Records; Electronic Signatures. These guidance documents were developed by FDA’s Part 11 Compliance Committee.

This is a draft, and industry comments will be important in shaping the final guidances. Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. The comment period ends December 24, 2001.

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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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