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Ofni Systems is a leader in computer system validation and compliance software:

  • ExcelSafe adds audit trails and user level security to MS Excel spreadsheets.
  • The Part 11 Toolkit provides MS Access with all technological tools for compliance with 21 CFR 11.
  • Part 11 Advisor assesses any software for compliance with 21 CRF 11.
  • FastVal produces validation documentation in 70% less time than traditional validation methods.


Contact us for more information about computer validation.

 

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CDER indicating increased inspections for compliance with 21 CFR 11