CFR Part 11 Compliance
The U.S. Food and Drug Administration adopted 21 CFR Part 11 in August of 1997 which allows for Electronic Records and Electronic Signatures to provide the equivalent change controls and security as paper records and handwritten signatures.
Due to the significance this regulation to our customers, Aegis's Discoverant product suite has been designed and tested to be 21 CFR Part 11 compliant which accelerates on-site validation and minimizes the impact on existing processes.