GMP News No. 261
GMP News 13 November 2002 |
FDA's New Draft Guidance on |
This Guidance regulates Part-11-conformmethods for generating electronic copies of electronic records that areprovided by the industry to FDA for review and inspection purposes. Thefollowing 7 requirements are laid down:
This document fills a regulatory gapconcerning the provision of copies of quality-relevant electronic recordsto FDA for inspection purposes. In establishing these rules, it intends toensure the loss-free transfer of electronic information. As usual, this Draft Guidance was releasedfor commenting by the industry within 90 days of publication. Author: Dr Gerhard Becker CONCEPT HEIDELBERG The Draft can be downloaded directly viathis link: |