The Part 11 Gap Analysis tool is the core part of Part 11 Advisor. Users evaluate their system against the entire text of 21 CFR Part 11, separated into distinct steps with interpretations and instructions for systems owners to use when performing their assessments. During the initial training session, Ofni Systems personnel use this screen to train users on Part 11 requirements while they fill out blank assessments in the classroom. Once the training session is completed, each user not only knows how to use the program, they have also completed most of their initial assessment!
Part 11 Advisor – Assess your compliance with 21 CFR 11.