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FDA Office of Regulatory Affairs Extends Use of MasterControl Quality Suite

Oct 30, 2018, 14:12 PM by Seeth Mcgavien

 

FDA Office of Regulatory Affairs Extends Use of MasterControl Quality Suite

FOR IMMEDIATE RELEASE
Contact: Jennifer Hurst, Sr. Director, PR & Campaigns
Phone: 1.801.560.9608
Email: jhurst@mastercontrol.com

SALT LAKE CITY, USA – October 30, 2018 – MasterControl Inc., a leading global provider of software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner, today announced that the company and its partner, i4DM, will extend their roles as providers of the MasterControl Quality Excellence™ solution for the U.S. FDA’s Office of Regulatory Affairs (ORA).

ORA, the lead office for all FDA field activities, purchased MasterControl software in 2009 as the primary tool for its quality managers to uniformly apply and monitor ORA work products and processes. The Office has decided to continue to expand the use of the MasterControl system within the agency, with a renewed focus on audit management solutions.

“MasterControl is honored to continue to assist the FDA’s Office of Regulatory Affairs in fulfilling its mission of protecting consumers and enhancing public health,” said Jonathan Beckstrand, CEO of MasterControl. “MasterControl’s mission to get lifesaving products to market sooner is well aligned with that of the ORA. Partnered with i4DM, our domain expertise and industry experience will prolong the delivery of a solid, long-term solution for the FDA.”

“The ORA staff is pleased to renew the contract we’ve had for many years with MasterControl and i4DM,” said Bryant Headley, quality management information system program manager at the FDA. “We’re looking forward to continuing our existing projects together and broadening the use of MasterControl solutions within the FDA.”

ORA supports the FDA’s seven product centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products entering the United States. It is at the forefront of building a public health safety net for the world’s complex regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices and 13 laboratories throughout the U.S.

ORA’s business units use solutions on the MasterControl platform for the following core procedures, while i4DM provides program management, security consulting and integration services to the Office:

  • Document control and management
  • Control of quality records
  • Management review
  • Audits
  • Control of nonconforming processes/products
  • Continual improvement
  • Corrective action
  • Preventive action
  • Complaints and feedback
  • Tracking custom processes

In addition to supporting the ORA, MasterControl also provides solutions to the Division of Pharmaceutical Analysis (DPA) of the FDA’s Center for Drug Evaluation and Research (CDER).

About MasterControl
MasterControl Inc. creates software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl’s integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and post-market surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use. For more information, visit www.mastercontrol.com.

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