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Sparta Systems Inc.

FDA Compliance

Survey: Regulatory Changes Drive Quality Management for Life Sciences

Quality and compliance systems viewed as business-critical investments

Published: Tuesday, June 1, 2010 - 10:56

(Sparta Systems: Holmdel, NJ) --  Current and anticipated regulatory changes are the chief driver of life science organizations’ quality management initiatives, according to a recent poll by Sparta Systems Inc., the maker of TrackWise software. Of the quality professionals surveyed, 97 percent indicated that regulatory concerns affect their company’s quality management initiatives either greatly (58%) or somewhat (39%).

As authorities continue to strengthen their oversight of regulated industries in 2010—from the increased frequency of audits designed to eliminate product recalls to new guidelines for ensuring food safety—quality management is becoming more proactive than reactive for both agencies and manufacturers. More than three-quarters (78%) of respondents to the Sparta Systems survey cited compliance concerns as a major reason for implementing the company’s TrackWise enterprise quality management software (EQMS), while 56 percent indicated improving operational efficiencies was a significant reason for deploying the software.

The survey also revealed that many companies’ quality and compliance improvements are being driven by top-level executives—not just IT departments or quality managers. In fact, the majority of life sciences organizations surveyed by Sparta Systems (91%) indicated that their top executives realize the business value of quality and compliance initiatives. Overall, EQMS software was widely cited by survey respondents as a business-critical investment (71%) that is being leveraged across multiple international locations (78%).

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About The Author

Sparta Systems Inc.’s picture

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.