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Part 11 Advisor

The Part 11 Advisor assesses your compliance with 21 CFR Part 11, Electronic Record and Electronic Signature systems, creates a Corrective Action Plans and tracks progress towards compliance.

Part 11 Advisor by Ofni Systems

Click on each step to review features and view screen shots from the Part 11 Advisor.

Program Benefits

  • Be ready for any audit in weeks, not months!
  • Build a well-trained workforce for evaluating new systems
  • Includes over 15 reports for scheduling and status updates

Additional Features

  • Packed with Project Management Tools
  • Program is automatically customized for each user
  • Expect short-term gains of 10-25% simply by educating your workforce about Part 11 requirements
Contact us for a free demonstration or further information on Part 11 Advisor.
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CDER indicating increased inspections for compliance with 21 CFR 11