Medical Device Companies Increasing Centralization of Quality Management and Compliance Processes

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Survey Data from Sparta Systems Finds Majority of Device Companies Leveraging Quality Management Software to Streamline and Centralize Critical Functions

With medical device companies continuing to grow their organizations globally and introduce new innovations in device design and development, more of these companies are seeking to centralize the management of vital quality and compliance processes, according to new data revealed today. In the survey from Sparta Systems, Inc., the maker of TrackWise® enterprise quality management software and the market leader in enterprise quality and compliance management solutions, which included responses from more than 380 medical device industry professionals, almost 60 percent of respondents indicated that their companies had been undergoing initiatives to make quality management a more centralized process. The same survey also found that 82 percent of respondents had implemented quality management software systems (EQMS) to help automate and streamline their quality initiatives, which included such critical functions as Complaint Handling, Corrective and Preventive Actions (CAPAs) and Change Control, often extending their use of the software to account for additional capabilities such as Supplier Quality Management, Training Management and electronic Adverse Event Reporting (eMDR/eMDV).

With regulatory bodies enforcing rigid standards for the manufacturing of medical devices to ensure consumer safety, more and more companies are seeking to manage their enterprise-wide quality and compliance initiatives from a single location, so that these efforts do not hinder their ability to innovate. In addition to this, the survey from Sparta Systems found that:

  • Almost a third of respondents successfully put forth a detailed business case or ROI calculation prior to their QMS implementation, educating business stakeholders on the bottom-line impact of centralized quality management for their organization.
  • At more than 78 percent of the companies that had deployed QMS, the software was viewed as an important tool to support more centralized systems and processes in the area of quality management and compliance.
  • Since implementing a quality management system, 68 percent of respondents believed that their compliance efforts were more effective with their QMS implementation than without it.

“It’s simply no longer feasible for companies to conduct their quality and compliance initiatives from disparate, siloed locations,” said Tim Mohn, Industry Principal, Sparta Systems. “Forward-thinking companies are recognizing a need to centrally manage their quality- and compliance-related data from a single location, and this survey data demonstrates that centralization is having a significant impact. As more companies see the value in implementing best-of-breed QMS to automate their quality and compliance processes, we will continue to work with these organizations to ensure that these investments are resulting in tangible, quantifiable ROI.”

Click here to learn more about Sparta Systems’ unique TrackWise solutions for medical device manufacturers.

About Sparta Systems
Sparta Systems, Inc. is an industry leader for global quality and compliance management systems. Its TrackWise® product is a web-based software application used by quality, manufacturing and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has more than 15 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. Read more about Sparta Systems and TrackWise software on the corporate website and blog /

Sparta Systems and TrackWise are trademarks or registered trademarks of Sparta Systems, Inc. All other marks are trademarks of their respective companies.


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Megan Garnett Coyle
Articulate Communications Inc.
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