Starting Gap Analysis with the Part 11 Advisor

The Part 11 Advisor facilitates the process of starting gap analysis. Part 11 Advisor assesses your 21 CFR Part 11, Electronic Record and Electronic Signature systems, creates Corrective Action Plans, tracks your progress towards compliance, and facilitates long term monitoring of your remediation plans.

As your personnel are trained to use Part 11 Advisor, they complete a compliance assessment of your systems (during the training session itself). During this initial training session, Ofni Systems training personnel will show you how to:

• Build or import your list of systems to evaluate for compliance with Part 11.
• Assign priorities for each system and designate responsibilities to the appropriate staff.
• Perform gap analysis against the actual text of 21 CFR 11 to determine if any disparities exist.
• Determine appropriate corrective actions for any gaps found during the assessment.
• Generate reports to show system evaluation reports, corrective action plans, and compliance summary reports.

Main Menu

The main menu will automatically show either items you are responsible for or the last four systems updated. It will also show upcoming corrective actions that are due.

Systems to Evaluate

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
  • Summary Reports