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Quality Nightmares #37: The Matador

29 March 2018

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MasterControl Sponsors Free RAPS Webinar: Preparing for Medical Device Single Audit Program (MDSAP) Audit Success

15 March 2018

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How an EQMS can make the transition to MDR seamless

14 December 2017

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MasterControl Earns ISO 9001:2015 Re-Certification for Quality Management

SALT LAKE CITY, USA - November 28, 2017 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 it has passed its ISO 9001:2015 Re-Certification Audit with flying colors.

ISO 9001:2015 is the latest revision of the world’s most widely applied international standard on quality management systems. Companies worldwide adhere to the standard to demonstrate to their customers that their products and services maintain the highest quality. MasterControl was one of the first companies in the world to receive certification, and is now one of the first to receive re-certification, which is required every three years.

“Because our customers rely on our software to help them achieve alignment with ISO 9001:2015, fundamentally, we believe that we should hold ourselves to the highest of standards,” said Jake Walton ASQ-CQA, CQPA, corporate operations and quality manager at MasterControl. “MasterControl received no citations for non-conformances or observations, which include departures from industry recognized best practices. In fact, the auditor said coming to audit our facilities is a pure joy for him because absolutely everything is in order. This re-certification can serve as an assurance to our customers that we have solid, comprehensive systems and processes in place to produce solutions and services that will help accelerate compliance and meet their own business objectives.”

The audit, which took place November 13-15, 2017, involved reviewing the MasterControl systems that ensure consistent product quality and customer satisfaction. Core processes received in-depth reviews, including: change control, corrective actions and deviation management, customer feedback and complaints, document control and record management, internal communication, product development, testing, validation, servicing and support, risk management, supplier management, and training management.

This ISO standard is a complex, risk-based standard. The re-certification validates MasterControl’s conformance with the ISO 9001:2015 standard, which was released in September 2015. This standard includes an increased emphasis on process-based quality management, integration of risk management concerns in all aspects of the quality management system and an emphasis on company leaders taking an active role in implementing and supporting quality processes.

About MasterControl

MasterControl Inc. produces software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl's integrated solutions securely manage a company's critical information throughout the entire product lifecycle while reducing overall costs and increasing internal efficiencies. More than 1,000 companies worldwide ranging from five employees to tens of thousands use MasterControl's suite of scalable cloud solutions for document management, quality management, electronic batch record management, supplier management, and clinical and regulatory information management. MasterControl solutions are known for being easy to implement, easy to validate and easy to use. For more information, visit