• Collect and review data.
  
• Choose from a list of industry-standard solutions, or enter your own.
  
• Build your Corrective Action Plans (CAP) for each system.
  
• Estimate dates, 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 core part and most valuable part of the program! The entire text of 21 CFR Part 11 is available, separated into distinct steps with interpretations and instructions for the systems owners to use when performing their assessments. During the initial training session, this is the screen that we walk through 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


We schedule a review session for each assessment in the program. As part of the review, we not only spot-check their responses, we also 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