MasterControl Inc., a global provider of quality management software solutions and services, has announced that the company and its partner, i4DM, will serve as the quality management system providers for a division of the US 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. The division plays a crucial role in fulfilling CDER’s mission to ensure the safety of over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
“MasterControl is excited to expand its existing project with FDA by adding the Center for Drug Evaluation and Research to its quality management platform,” said Matt Lowe, MasterControl Executive Vice President. “MasterControl’s mission to get lifesaving products to market sooner is well aligned with that of FDA and, specifically, CDER as it pertains to new pharmaceuticals.”
DPA is the second FDA division to implement MasterControl. ORA, the lead entity for all of the FDA’s field activities, purchased MasterControl software in 2009 as the tool for its quality managers to uniformly apply and monitor ORA work products and processes.
ORA supports the FDA’s seven product centres by inspecting regulated products and manufacturers, conducting sample analysis on regulated products and reviewing imported products entering the United States.