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 the systems owners to use when performing their assessments. During the initial training session, Ofni Systems training 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 also have most of their initial assessment completed!

Screen shot of the Gap Analysis screen.

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 their responses and help them enter corrective actions for any gaps found during the assessment. Many users already have some knowledge about software updates that are available or procedural gaps that can be addressed, and we know from experience what other industry solutions are available for different types of software.

Screen shot of the Corrective Actions screen.

Setup

Tracking