FDA Division Taps MasterControl to Serve as QMS Provider


Company News Release

SALT LAKE CITY, USA –MasterControl Inc., a global provider of quality management software solutions and services, today 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. 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.”

MasterControl Expands Role

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 centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products entering the United States.

About MasterControl

MasterControl is a committed team of quality, regulatory and software experts who work to empower regulated companies to get their products to market faster. MasterControl’s quality management software solutions reduce overall costs, increase efficiency and accelerate compliance, creating a significant competitive advantage for customers. Drawing upon unparalleled industry experience, MasterControl offers a suite of seamlessly integrated and scalable software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management and much more. MasterControl’s complete quality management solution is designed for easy implementation, validation and use, continually improving on the promise of Compliance Accelerated.  For more information about MasterControl, visit www.mastercontrol.com

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