CGA M-16-2016

$9.75

Guidance for Electronic Records and Signatures in the U.S. and Canadian Food, Drug, and Medical Device Gas and Gas Equipment Industry

Published By	Publication Date	Number of Pages
CGA	2016-03-01	16

Guaranteed Safe Checkout

Category: CGA

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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).

Additional information