For more than ten years, Ofni Systems has provided FDA regulated industries, including pharmaceuticals, bioscience, medical devices and clinical trials organizations, with software and consulting services to comply with 21 CFR Part 11, Electronics Records and Electronic Signatures, HIPAA (Health Insurance Portability and Accountability Act) and Annex 11, Computerized Systems. Ofni Systems software automates complex record generation and provides the technological tools necessary for several common software applications to be compliant; our consulting services ensure that you can maintain your systems in a validated state.

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