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Systems to Evaluate screen

Part 11 Advisor facilitates your evaluation of systems for Part 11 compliance. Information is entered for each system, which allows Part 11 Advisor to create schedules for review. Part 11 Advisor maintains a list of all systems to review or evaluate, and allows users to enter summary information about each system before or during the actual assessment.

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.