The Part 11 Advisor assesses your 21 CFR Part 11, Electronic Record and Electronic Signature systems, creates a Corrective Action Plan and tracks your progress towards compliance, builds corrective action plans 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 4 systems updated. It will also show upcoming corrective actions that are due.

Screen shot of the Part 11 Advisor main menu screen.

Systems to Evaluate

Assessments