Publication Details

[M-16] 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; 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).


Category Medical Gases     Standards & Guidelines
Keywords electronic record  |  electronic signature  |  medical device  |  medical gases
Related M-17  |  M-2  |  M-3