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 their 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. 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:

• Document control
• CAPA (Corrective Action and Preventive Action)
• Complaints/feedback
• Management review
• Audit management
• Control of nonconformance
• 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.

Partnering for success

i4DM will provide program management and security consulting services and will serve as the integration expert after the initial installation/configuration, integrating the QMS system with seven or more legacy systems within the agency.

Mike Peart, i4DM’s CEO said: “We’re very excited that the FDA selected us for this significant project. We look forward to working with both the FDA and MasterControl for a smooth and successful implementation that will help the FDA automate many of their core quality systems.”

“i4DM has the expertise in software integration consulting for large organizations that this job requires and MasterControl has the software solution,” said Michael Bothe, MasterControl’s vice president for strategic alliances. “As partners we provide a strong integrated solution to meet the FDA’s requirements.”

About MasterControl Inc.

MasterControl produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company’s critical information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit www.mastercontrol.com, email info@mastercontrol.com or call 866-747-8767 (US).

About i4DM

i4DM is a full-service information technology firm, established in 2002 by founder Michael Peart. The company quickly established a loyal customer base and has been profitable since inception. Through controlled expansion, i4DM has grown to employ 50+ people who bring years of information technology experience and business acumen to clients throughout the mid-Atlantic region. Valued clients include a major auto manufacturer, construction contractors, and insurance and risk management companies.

i4DM works closely with clients to gain an understanding of their environment and ascertain the technology needed to quickly gain competitive advantage. Client satisfaction and project status is continually monitored to ensure timely and comprehensive delivery. It is i4DM’s mission to provide “solutions that ensure customer success through the application of innovative technology.” For more information about i4DM, visit www.i4dm.com or call 410-729-7920.