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.

Whether you are a CIO of a global corporation or heading a start-up, Ofni Systems can assess your Part 11 compliance, computer validation or develop policies and procedures for electronic data control.