FDA Selects QMS Solution From MasterControl, i4DM

MasterControl and i4DM have been selected as the software provider and implementation team of a quality management system (QMS) for the Food and Drug Administration (FDA).

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 US, in regional offices, district offices, laboratories and headquarters.

FDA’s implementation phase will consist of the configuration of MasterControl’s quality management system solution to improve ORA’s vital quality processes, including: Document Control;CAPA (Corrective Action and Preventive Action); Complaints/Feedback; Management Review; Audit Management; Control of Nonconformance; and Continual Improvement.

Jonathan Beckstrand, CEO of MasterControl, said: 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.”