FDA’s CDER Chooses MasterControl as QMS Provider

MasterControl Inc., a provider of quality management software solutions and services, announced that the company and its partner, i4DM, will serve as the quality management system providers for a division of the U.S. FDA’s Center for Drug Evaluation and Research (CDER). The two companies are also the QMS providers for the FDA’s Office of Regulatory Affairs (ORA).

CDER’s Division of Pharmaceutical Analysis (DPA) will be adopting MasterControl’s full QMS to manage documents, training records, audits, CAPAs, change control, and other quality processes.