CGA M-16 – Standard for Food Drug & Medical Device Gas & Gas Equipment Manufacturers on Electronic Records & Signatures
This publication is based on FDA’s August 2003 Guidance for Industry Part 11 Electronic Records; Electronic SignaturesâScope and Application and satisfies the criteria of 21 CFR Part 11 § 11.1 (a) âThe 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.â?/p>
This publication also harmonizes with PIC/S Guide for good manufacturing practice for medicinal products Annex 11 âComputerised Systemsâ?(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.
Product Details
- Edition:
- 2nd
- Published:
- 02/23/2022
- Number of Pages:
- 16
- File Size:
- 1 file 380 KB
- Note:
- This product is unavailable in Russia Ukraine Belarus
