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WITHDRAWN BY FDA Feb 2003 as not representative of their current thinking.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 Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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