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Growing Supply Chain Complexity Increasing Impact on Medical Device Company Operations
Date:10/13/2009

(30 percent) and homegrown solutions or paper-based processes (12 percent).
  • IT system deployments were evenly split between business unit-specific implementations (39 percent) and those that spanned the global enterprise (43 percent).
  • Despite the FDA's recently announced timetable for electronic submission of post-market adverse event reports (eMDR), 60 percent of companies surveyed in Sparta Systems' poll reported that their companies had not yet begun preparing for electronic submission.

    • "Stringent standards in the medical device industry continue to drive the advancement of quality and compliance processes at manufacturers, yet much work remains to be done," said Mike Jovanis, vice president, product management at Sparta Systems. "While some organizations are making progress, many legacy IT solutions in the device industry are falling short of meeting global, enterprise-wide quality and compliance requirements. Medical device manufacturers will need to embrace the concept of consolidated quality systems and implement enterprise-class solutions that track and manage quality and compliance processes, while integrating with adjacent applications."

    Sparta Systems will be exhibiting at AdvaMed MedTech 2009 in Washington, D.C., Booth # 402. To schedule a media briefing at the event, please contact: Katy Zack, kzack@articulatepr.com or 212.255.0080, ext. 11.

    About Sparta Systems

    Sparta Systems, Inc. is the 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 14 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offer
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    SOURCE Sparta Systems, Inc.
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