What does the FDA say about validating software?

Kevin Ballard/Director of Software Validation/MasterControl Software validation is required by law for companies that operate under the purview of the FDA and EMA. Companies must validate their systems (such as those for quality management and compliance) to comply with a number of regulations including 21 CFR 11, 21 CFR 210-211, 21 CFR 820, 21 CFR 600, and 21 … Continue reading What does the FDA say about validating software?