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Corrective Actions Wizard Screen

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.

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.