For Life Science Companies

FDA Chooses MasterControl's QMS

MasterControl, a global provider of quality management systems (QMS), is pleased to announce that it has been selected as the QMS software provider for the U.S. Food and Drug Administration (FDA). More specifically, the Office of Regulatory Affairs (ORA) within the FDA has contracted with MasterControl through its partner, i4DM.

To learn more about this agreement and to see the official press release please click here.

The mission of the Office of Regulatory Affairs is to protect consumers and enhance public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products. ORA plans to implement MasterControl as its QMS solution throughout all of its various divisions and offices. ORA's field auditors are among those slated to use MasterControl's QMS Software.

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 Office of Regulatory Affairs."

Contributing factors that made MasterControl's quality management system a great fit for ORA include its flexibility, functionality, and the cooperation, knowledge, and professional commitment of MasterControl personnel to support the success of the project.

To speak to a representative about how MasterControl can help your company comply with FDA regulations, please call us at 866-747-8767 or email us at info@mastercontrol.com.

To learn more about the FDA's agreement with i4DM and MasterControl please click here.

View MasterControl Videos Using MasterControl for FDA Compliance (3:53) Passing Audits and Inspections with MasterControl (3:08) Tracking and Trending with MasterControl (2:49)