Ofni Systems Inc.

Ofni Systems, a private computer compliance services and software company, is headquartered in Research Triangle Park, NC. Ofni Systems was founded in 1999, dedicated to helping companies address the requirements of 21 CFR Part 11, Electronic Records and Electronic Signatures. This regulation gives companies the freedom to do away with paper-based systems and streamline nearly every part of their operations. FDA-regulated industries, including pharmaceuticals, bioscience, medical devices, and clinical trials, utilize Ofni Systems’ proven software and consulting to become compliant with 21 CFR Part 11 and add value to their business processes. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while their products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures.