The second of our three sessions addressing 23 CFR Part 11 Electronic Records; Electronic Signatures goes over the second main aspect of 21 CFR Part 11 which is to employ at least two distinct identification components and how to limit system access to authorized individuals. Though this is important to bio-medical companies, any company that uses software to manage equipment records will find value in these requirements. Walter takes you through the actual FDA regulation pertaining to this session as well as demonstrates how the IndySoft software can be configured to be compliant with the regulation using the Profile Manager Utility.
Check out Part 1 of the series here: [ Ссылка ]
