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Guidance for Electronic Records and Signatures in the U.S. and Canadian Food, Drug, and Medical Device Gas and Gas Equipment Industry
Handbook / Manual / Guide by Compressed Gas Association, 03/01/2016

Description

This guideline is based upon FDA’s August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and Application and satisfies the criteria of 21 CFR Part 11, § 11.1 (a) “The regulations in this part set forth the criteria under which the agency considers e-records, e-signatures, and handwritten signatures executed to e-records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper”.

This guideline also harmonizes with PIC/S Guide for good manufacturing practice for medicinal products, Annex 11 “Computerised Systems” (as adopted in Canada).