Ofni Systems’ Electronic Data Management software reliably and efficiently automates complex record generation. FDA regulated industries, including pharmaceuticals, bioscience, medical devices and clinical trials, utilize Ofni Systems’ proven software and consulting to comply with 21 CFR Part 11, Electronics Records and Electronic Signatures, HIPAA (Health Insurance Portability and Accountability Act) and Annex 11, Computerized Systems.

Whether you are a CIO of a global corporation or heading a start-up, Ofni Systems can assess your compliance, validate your computer systems or assist your company with developing policies and procedures for electronic data control.