MasterControl and i4DM to implement a quality management system for the U.S. FDA

Oct 30 2009

MasterControl, a global provider of software solutions that enable regulated companies to improve internal efficiency and reduce overall costs while accelerating time to market, announced today that the company and i4DM, a MasterControl partner, have been selected as the software provider and implementation team of a quality management system (QMS) for the Food and Drug Administration (FDA).

After an extensive evaluation of industry solution providers, the FDA's Office of Regulatory Affairs (ORA) selected MasterControl’s quality management software solution to be used by its agencies that are engaged in field investigations enforcement, and scientific laboratory analysis of field samples. The system will be implemented across the United States, in regional offices, district offices, laboratories and headquarters. The FDA’s implementation phase will consist of the configuration of MasterControl's quality management system solution to improve ORA's vital quality processes, including:

1. Document Control
2. CAPA (Corrective Action and Preventive Action)
3. Complaints/Feedback
4. Management Review
5. Audit Management
6. Control of Nonconformance
7. Continual Improvement

Jonathan Beckstrand, MasterControl CEO, said, "Given the thoroughness of the FDA’s evaluation process it is particularly exciting to have been selected. We are very pleased that the FDA recognizes the quality of our QMS solution and our absolute commitment to the success of this project. Together with i4DM, our domain expertise and industry experience will create a solid, long-term solution for the FDA.”

Contributing factors that made MasterControl’s quality management system a great fit for the FDA included its flexibility, functionality, and the cooperation, knowledge, and professional willingness of MasterControl personnel to support the success of the project.

SOURCE MasterControl Inc.