Medical Device Companies Increasing Centralization of Quality Management and Compliance

QMS software improves compliance efforts, according to survey

Published: Wednesday, September 7, 2011 - 12:11

(Sparta: Holmdel, NJ) -- 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 in a survey from Sparta Systems, a leading provider of enterprise quality management software. The responses from more than 380 medical-device industry professionals indicated that almost 60 percent of 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 systems (QMS) software 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.

With regulatory bodies enforcing rigid standards for the manufacturing of medical devices to ensure consumer safety, more companies are seeking to manage their enterprisewide 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 one-third of respondents successfully put forth a detailed business case or return on investment (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 software, it 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 software implementation than without it.

“It’s simply no longer feasible for companies to conduct their quality and compliance initiatives from disparate, siloed locations,” says Tim Mohn, industry principal at 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 demonstrate that centralization is having a significant impact. As more companies see the value in implementing best-of-breed QMS software 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 The Author

Sparta Systems Inc.

Founded in 1994, Sparta Systems Inc. is the leading provider of enterprise quality management software. In addition to its U.S. operations, the company provides sales and services to Europe, Asia, and Australia through its subsidiary, Sparta Systems Europe Ltd.

Visit www.spartasystems.com.