Part 11 Evaluations and Review

Part 11 Evaluation and Review Methodology

Part 11 Advisor follows a standard methodology for Part 11 Evaluation and Review:

• Collect and review data to identify Part 11 gaps.
• For all identified Part 11 gaps, enter a proposed solution. Choose from a list of industry-standard solutions, or enter your own.
• Build your Corrective Action Plans (CAP) for each system.
• Estimate costs and time required for each part of the CAP.
• Begin implementing short-term actions immediately while you review and approve your long-term plans for compliance.

Part 11 Gap Analysis

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!

Corrective Actions Wizard

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.

Additional Information

Part 11 Advisor – Assess your compliance with 21 CFR 11.

• Part 11 Advisor Main Screen
• Evaluation and Review
  • Gap Analysis screen
  • Corrective Action Wizard
• Long Term Tracking of Part 11 Assessment Corrective Actions
  • Corrective Action Reports
  • Summary Reports