FDA Selects MasterControl From SynCardia

FDA has selected MasterControl from SynCardia Systems as the new quality management system for the Food and Drug Administration (FDA). MasterControl also provides the quality management system for SynCardia Systems.

FDA said that MasterControl is expected to be used by the FDA’s Office of Regulatory Affairs (ORA) 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.

Rodger Ford, president and CEO of SynCardia, said: “The FDA will find a familiar system at SynCardia. We reviewed more than 30 quality management systems before finally selecting MasterControl in 2005. Since the validation and launch of the software in 2006, it has been the electronic backbone of all SynCardia quality documents.

“At SynCardia, MasterControl has allowed a small group of people to achieve extraordinary results. We have only 42 employees, but through MasterControl, we touched 5,500 documents last month. The system allows us to be efficient, accountable and responsive so that we can focus on the needs of our customers, patients and physicians around the world.”