As the Part 11 assessment progresses, Part 11 gaps are identified. The Corrective Actions Wizard allows users to propose solutions for each gap, including estimating proposed costs for the solution and a time-line to address the issue. During the initial training session, Ofni Systems training personnel spot-check responses and help enter corrective actions for any gaps found during the assessment. Many users already have knowledge of available software updates or of procedural gaps that can be addressed, and we know from experience other industry solutions available for different types of software.
Part 11 Advisor – Assess your compliance with 21 CFR 11.