FDA 21 CFR Part 11 Software Systems
FDA 21 CFR Part 11 software systems, like MasterControl's Quality Excellence, meet the complex regulations that provides criteria for acceptance by the FDA of electronic records and signatures as equivalent to paper records and handwritten signatures. The regulation, which applies to all FDA program areas, is meant to permit the widest possible use of software technology. The use of software for electronic records for submission to FDA is voluntary.