Historical
CGA M-16-2016
Guidance for Electronic Records and Signatures in the U.S. and Canadian Food, Drug, and Medical Device Gas and Gas Equipment Industry
This guideline is based upon FDA’s August 2003 Guidance for Industry Part 11, Electronic Records; ElectronicSignatures -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 handwrittensignatures executed on paper” [3, 2].
CONTENT PROVIDER
Compressed Gas Association, Inc. [cga]
Compressed Gas Association, Inc. [cga]