Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology

More Features

FDA Compliance News
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains

More News

MasterControl Inc.

FDA Compliance

Company News: FDA Selects QMS Software by MasterControl and i4DM

Will be used by agencies engaged in field investigations enforcement and scientific lab analysis.

Published: Friday, October 30, 2009 - 10:43

(MasterControl: Salt Lake City) -- MasterControl, a global provider of software solutions that enable regulated companies to improve internal efficiency and reduce overall costs while accelerating time to market, recently announced that the company and i4DM, a MasterControl partner, have been selected as the software provider and implementation team of a quality managment system (QMS) for the Food and Drug Administration (FDA).

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 United States, in regional offices, district offices, laboratories, and headquarters. The FDA’s implementation phase will consist of the configuration of MasterControl’s QMS solution to improve ORA’s vital quality processes, including:

• Document control
• Corrective and preventive action (CAPA)
• Complaints/feedback
• Management review
• Audit management
• Control of nonconformance
• Continual improvement

“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,” says Jonathan Beckstrand, MasterControl's CEO.

Contributing factors that made MasterControl’s QMS 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 and configuration, integrating the quality management system with seven or more legacy systems within the agency.

“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,” says Mike Peart, i4DM’s CEO.

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


About The Author

MasterControl Inc.’s picture

MasterControl Inc.

MasterControl software solutions incorporate industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment companywide. MasterControl solutions include quality management, document management, product life-cycle management, audit management, training management, document control, bill of materials, supplier management, submissions management, and more.