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Ofni Systems provides your FDA-regulated business with software and products to assist with 21 CFR 11, Annex 11, HIPAA, and other regulatory requirements for electronic data and signatures. All Ofni Systems software and products are compliant with 21 CFR 11. Software and other products have available validation packages, help files, and training materials. Support plans are also available.
FastVal allows you to manage validation projects, automate the creation of validation documents, generate validation metrics, and execute test case protocols electronically. FastVal integrates into your existing validation process, and all validation outputs are configurable to meet your existing documentation standards. FastVal reduces the amount of time required to perform a validation project by up to 70%.
ExcelSafe provides your MS Excel spreadsheets with all of the technological features required for compliance with 21 CFR 11, including audit trails, electronic signatures, and user-level security. ExcelSafe requires no changes to existing spreadsheets or changes to your current processes.
Implement and validate compliant clinical trial databases in weeks (not months) with Ofni Clinical.
The Part 11 Toolkit adds audit trails, automatic timeouts, electronic signatures, and security to any MS Access program.
The Part 11 Advisor is a program for helping you achieve compliance with 21 CFR Part 11, Electronic Records, Electronic Signatures. The Part 11 Advisor faciliates the assessment of your systems and creates reports to identify any gaps.
Ofni Systems will create custom 21 CFR 11/Annex 11 compliant software and database solutions to meet your specific company needs. We have created numerous such programs for small and large organizations.
Ofni Systems is dedicated to ensuring electronic record compliance. We create validation packages to ensure custom software is compliant with 21 CFR 11 and Annex 11. If you have an existing program that needs validation or needs to be made compliant with 21 CFR 11 or Annex 11, please contact us.