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:
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