CGA M-16-2022

Standard for Food, Drug, and Medical Device Gas and Gas Equipment Manufacturers on Electronic Records and Signatures

This publication is based on 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 electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper”.   This publication also harmonizes with PIC/S Guide for good manufacturing practice for medicinal products, Annex 11 “Computerised Systems” (as adopted in Canada).  In addition to the guidance in this publication, see CGA M-27, Guideline for Complying with Data Integrity Regulatory Expectations, for more information on compliance with data integrity requirements for medical gases.