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Part 11 Gap Analysis Screen

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!

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
• System Evaluation Reports
• Summary Reports

Part 11 Assessments - Ofni Systems can assess all of your systems for compliance with 21 CFR 11.