The Part 11 Advisor facilitates the process of starting gap analysis. Part 11 Advisor assesses your 21 CFR Part 11, Electronic Record and Electronic Signature systems, creates Corrective Action Plans, tracks your progress towards compliance, and facilitates long term monitoring of your remediation plans.
As your personnel are trained to use Part 11 Advisor, they complete a compliance assessment of your systems (during the training session itself). During this initial training session, Ofni Systems training personnel will show you how to:
The main menu will automatically show either items you are responsible for or the last four systems updated. It will also show upcoming corrective actions that are due.
Part 11 Advisor maintains a list of all systems to review or evaluate and allows users to enter summary information about each system before or during the actual assessment.
Part 11 Advisor – Assess your compliance with 21 CFR 11.