Day: January 10, 2022

21 CFR Part 11 : Electronic Signature & LMS compliance

The FDA’s data integrity requirement calls for evidence of authenticity. In other words, when someone—let’s call her Mary—is validated on a standard operating procedure (SOP), we need to ensure that she is authenticated, meaning that no one else was logged in to read the SOP for her. This is a part of individual responsibility in […]