MasterControl Continues Role as QMS Provider for FDA’s Office of Regulatory Affairs

MasterControl Inc., a global provider of quality management software solutions and services, today announced that the company and its partner, i4DM, will continue their roles as the quality management system providers for the U.S. FDA’s Office of Regulatory Affairs (ORA).

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. The Office recently decided to expand the use of its system through MasterControl’s All Access suite of products.

“MasterControl is honored to assist the FDA’s Office of Regulatory Affairs in fulfilling its mission of protecting consumers and enhancing public health,” said Matt Lowe, MasterControl executive vice president.

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.

ORA’s business units use the MasterControl system for the following core procedures, while i4DM provides program management, security consulting, and integration services to the office:

• Document control and management
• Control of quality records
• Management review
• Audits
• Control of nonconforming processes/products
• Continual improvement
• Corrective action
• Preventive action
• Complaints and feedback
• Tracking custom processes

About MasterControl

MasterControl produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company’s critical information throughout the entire product lifecycle. MasterControl software is known for being easy to implement, easy to validate, and easy to use. MasterControl solutions include quality management, document management, product lifecycle management, audit management, training management, document control, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the enterprise. For more information about MasterControl, visit www.mastercontrol.com or call 1.800.825.9117 (U.S.); +44 (0) 1256 325 949 (Europe); or +81 (03) 5422 6665 (Japan).

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Contact information

MasterControl Inc.
Jason Clegg, 801-942-4000
jclegg@mastercontrol.com