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US FDA takes QMS S/w

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CIOL Bureau
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SALT LAKE CITY: MasterControl, a provider of software solutions to improve internal efficiency and reduce overall costs, 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).

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After an extensive evaluation of industry solution providers, as a press release adds, 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.

 

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.