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).
Product Details
- Edition:
- 1st
- Published:
- 03/01/2016
- Number of Pages:
- 16
- File Size:
- 1 file , 1000 KB
