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MasterControl “MasterControl Inc.” is a privately-held global provider of quality management and compliance software solutions and services. The company, which employs more than 200 people, is headquartered in Salt Lake City, Utah, with offices in Europe and Asia and a network of international partners and resellers. MasterControl and its partner, i4DM, provide the U.S. Food & Drug Administration’s Office of Regulatory Affairs (ORA) with its quality management system (QMS).^[1] In 2014, Software Magazine ranked MasterControl #369 in its list of the world’s 500 largest software and service companies.^[2] The company was one of only two companies in the compliance management sector to make the Software 500.

History

The company was founded in 1993 as a niche software developer that catered to manufacturers conforming to International Organization for Standardization (ISO) quality standards. The software solution was known as MasterControl™, while the company was called Document Control Systems.

Within a decade, the company’s products and services had expanded beyond its document-management niche. Its customer base also grew, extending to other regulated industries, such as life science companies under the FDA jurisdiction and those that adhere to EU and other international directives and standards.

In 2003, the company was purchased by Beckstrand & Associates. In 2005, the company became MasterControl Inc., aligning its corporate name with the popular brand.

Platform and Services

All MasterControl applications are built on a common web-based platform. Its connectivity facilitates the management of individual quality processes, such as document control, training, CAPA, and audit and risk management, which are critical to regulated companies, in one seamless environment. Centralizing data allows quality process to be standardized and improves visibility, enabling users to react more quickly to nonconformances and other quality events. In many industries, such as life sciences and food manufacturing, federal regulations are pushing manufacturers toward close-loop quality.^[3] The company also offers a cloud-based QMS solution.

In addition to software, MasterControl provides a myriad of services to help users implement an enterprise QMS quickly, as well as ongoing education, training, quality and compliance consulting and technical support services.

Its integrated solution is designed to comply with rigorous regulations [such as Food and Drug Administration (FDA), Medicines and Healthcare Products Regulatory Agency (MHRA), European Medicines Agency (EMA), and the Ministry of Health Labor and Welfare (MHLW) rules], guidelines [European Union (EU) Annex 11 and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)], and standards [International Organization for Standardization (ISO), Good x Practices (GxP), and EU Good Manufacturing Practices (GMP)].

The solution is widely used in the following industries:

· Life Science Companies: pharmaceutical, biotech, medical device, diagnostics, blood and biologics, dietary supplements, contract research organizations;

· Manufacturers: food and beverage, aerospace/defense, automotive, oil and gas, high-tech, chemicals; and

Service-Oriented Organizations: healthcare and government.

Awards & Recognition

MasterControl has received numerous awards for its software and contributions to the community. These include: Software Magazine’s Software 500 in 2010 (#448), 2011 (#386), 2012 (#408), 2013 (#376), 2014 (#369)^[4]; Utah’s Best and Brightest (2015)^[5]; The MountainWest Capital Network (MWCN) Utah 100 Award, which recognizes the 100 fastest growing companies in the state, in 2002 ^[6], 2003^[7], 2004^[8], 2008^[9], 2009^[10], 2010^[11], 2011^[12], 2012^[13], 2013^[14]; and Utah Business magazine’s Fast 50 in 2009^[15] and again in 2014^[16]. In 2011, the company was named to Inc. magazine’s Inc. 500|5000, an exclusive ranking of the nation’s fastest-growing private companies.^[17]

See Also

· Enterprise software

· Governance, risk management, and compliance

· Regulatory compliance

References

[1] “Company News: FDA Selects QMS Software by MasterControl and i4DM”.Quality Digest. 30 October 2009. Retrieved 3 June 2015.

[2] Desmond, John (October 2014). “2014 Software 500” Software Magazine. Retrieved 3 June 2015.

[3] Bredenberg, Al (15 July 2014). “Closed-Loop Quality: Not Your Father’s Quality Control”. ThomasNet.com/Industry News/Tech Trends. Retrieved 4 June 2015.

[4] “Software 500”. SoftwareMag.com. Search Buyers Guide [database]. Retrieved 4 June 2015.

[5] Peters, Rachel (13 May 2015). “Utah’s Best and Brightest”. Big Leap [blog]. Retrieved 4 June 2015.

[6] “2002 Utah 100” (as Document Control Systems, Inc.). MountainWest Capital Network. Retrieved 4 June 2015.

[7] “2003 Utah 100” (as Document Control Systems, Inc.). MountainWest Capital Network. Retrieved 4 June 2015.

[8] “2004 Utah 100” (as Document Control Systems, Inc.). MountainWest Capital Network. Retrieved 4 June 2015.

[9] “2008 Utah 100.” MountainWest Capital Network. Retrieved 4 June 2015.

[10] “2009 Utah 100.” MountainWest Capital Network. Retrieved 4 June 2015.

[11] “2010 Utah 100.” MountainWest Capital Network. Retrieved 4 June 2015.

[12] “2011 Utah 100.” MountainWest Capital Network. Retrieved 4 June 2015.

[13] “2012 Utah 100.” MountainWest Capital Network. Retrieved 4 June 2015.

[14] “2013 Utah 100.” MountainWest Capital Network. Retrieved 4 June 2015.

[15] “MasterControl Named to Utah Business Fast 50 2009” (27 August 2009). MasterControl News. Retrieved 4 June 2015.

[16] “Fast 50.” Utah Business magazine. 2 September 2014. Retrieved 4 June 2015.

[17] “The 2011 Inc. 5000: Meet the fastest growing private companies in America.” Inc. magazine. Retrieved 3 June 2015.