Ofni Systems provides your FDA regulated business with the highest quality software to assist you with your compliance with 21 CFR 11, Annex 11, HIPAA and other regulatory rules for electronic data and signatures. All Ofni Systems programs have associated validation packages, training materials and are compliant with 21 CFR 11. Support plans are also available.
Ofni Systems can also develop custom software to meet your company's specific needs with 21 CFR Part 11, Annex 11 and HIPAA.
FastVal Validation Document Generator
Manage your validation projects, produce validation documentation and execute test case protocols. ... More
ExcelSafe
ExcelSafe makes existing MS Excel spreadsheets compliant with all the technical requirements of Part 11 including audit trails, electronic signatures and user-level security. … More
Part 11 Advisor
The Part 11 Advisor is a program for helping you achieve compliance with 21 CFR Part 11, Electronic Records, Electronic Signatures. ... More
GxP Auditor
GxP Auditor manages and tracks all aspects of GxP compliance audits, from Auditor Requests to Final Observation Responses. ... More
The Part 11 Toolkit
Add audit trails, auto-timeouts, electronic signatures and security to any MS Access program. ... More
MedWatch Adverse Events Reporter
The MedWatch Adverse Events Reporter is a program for the creation, maintenance and tracking of your FDA Form 3500A submissions. ... More
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