Publication

M-16: Standard for Food, Drug, and Medical Device Gas and Gas Equipment Manufacturers on Electronic Records and Signatures

Abstract

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.

Access Publication

Member Price:
$23
Subscriber Price:
$23
Non-Member Price:
$41

Member E-Pub Price:
$0
Subscriber E-Pub Price:
$0
Non-Member E-Pub Price:
$41
Buy Hard Copy
Purchase E-Pub
View Table of Contents (free)

Properties

Edition:
2
Published:
February 2022
Status:
Available To the Public
Size:
8 pages
Publisher:
CGA
Special Attributes:
Notes:
Committee:
Medical Gases

Cataloging

Category
Medical Gases     Standards & Guidelines
Keywords
electronic record  |  electronic signature  |  medical device  |  medical gases
Related
M-17  |  M-2  |  M-27  |  M-3