|FDA’s Office of Regulatory Affairs (ORA) is |
expanding its use of MasterControl's software.
by Cindy Fazzi
Editor, MasterControl Insider
The U.S. Food and Drug Administration (FDA) has been protecting American consumers for over 100 years. In the face of increasing global interdependence, the FDA’s responsibility has expanded by necessity; it works with its counterparts throughout the world to help ensure product safety and quality.
The FDA’s emphasis on quality standards is reflected in its vision to dedicate itself to “world-class excellence as a science-based regulatory agency with a public health mission.” The same vision drives the FDA’s Office of Regulatory Affairs (ORA), the lead entity for all of the FDA’s field activities. ORA states plainly its commitment to quality and continual improvement (1). It emphasizes quality within its ranks and applies the same rigorous quality standards it expects from the industry.
ORA 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 (2).
MasterControl and its partner, i4DM, will continue their roles as the quality management system providers for ORA. “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.
This article is related to the Whitepaper: The Future of the FDA: Operating in an "Electronic World" To get the full details, please download your free copy.
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
- Control of nonconforming processes/products
- Continual improvement
- Corrective action
- Preventive action
- Complaints and feedback
- Tracking custom processes
(1) The ORA’s mission and vision, viewed on Nov. 13, 2014, at
(2) To read the announcement about the continuing role of MasterControl and i4DM as ORA’s QMS providers, go to: http://www.businesswire.com/news/home/20141112005257/en/MasterControl-Continues-Role-QMS-Provider-FDA%E2%80%99s-Office#.VGTDQU1OW71
Cindy Fazzi is the editor of MasterControl Insider, a monthly publication for MasterControl users. She writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.