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 in addressing 21 CFR Part 11 and HIPAA. Let Ofni Systems make knowledge management simple for you. Contact us for a free demonstration of any of our software products.

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