Press Releases

  • Sparta Systems Partners with Navitas to Provide Comprehensive Solution for IDMP Compliance

    HAMILTON, N.J. Sept. 13, 2016Sparta Systems, Inc., an industry pioneer and a global leader in enterprise quality management software (EQMS) solutions, and Navitas, a leading global consulting, business process outsourcing and technology provider, today announced an integrated solution for life sciences organizations that will enable compliance with the upcoming Identification of Medicinal Products (IDMP) regulations, to be finalized by the European Medicines Agency (EMA) in early 2017.
     
    IDMP provides a common, global framework for identifying medicinal products, creating full transparency between regulators, manufacturers, suppliers and distributors, and ultimately ensuring greater public safety. As such, any life sciences organization that intends to manufacture and/or market medicinal products within the European Union is required to comply.
     
    However, the vast amount of data disclosure required for IDMP compliance poses a significant challenge to organizations, as all too often product information is scattered across a variety of systems and business functions—including partners and contract manufacturers—and no single entity maintains ownership. Many organizations do not know how to collect and process this unstructured data in a cost-effective, simplified manner.
     
    In advance of the EMA’s final guidance, Sparta Systems and Navitas have partnered to ensure organizations are prepared for implementation by offering an integrated solution: idmpREADY™.
     
    idmpREADY seamlessly combines Navitas’ data management technologies to capture, record, publish and maintain IDMP data points, together with Sparta’s TrackWise EQMS and TrackWise QualityConnect integration framework to define, track, exchange and report IDMP core processes.
     
    “Given that the requirements are not fully established—and will not be for several more months—many companies do not see IDMP implementation as an urgent business challenge. This could prove a severe miscalculation on their part,” said David Gwyn, Head of the Content Management and Collaboration Practice, Navitas. “Organizations will find themselves in an unfavorable position if they are not primed for the eventual submissions and application deployment once approved. The U.S. FDA is also expected to follow with a similar approach.”
     
    “The amount of data required for IDMP compliance quickly adds up when considering its entire structure,” said Tom Sullivan, Vice President of Product Management, Sparta Systems. “One active ingredient that produces three pharmaceutical products, distributed across 50 markets with four different package sizes, may total more than 600 IDMP entries. idmpREADY enables our customers to successfully navigate this complex process and the overabundance of data from day one.”
     
    For more information on IDMP compliance, as well as related consulting services, visit www.spartasystems.com.


    About Navitas 

    The Navitas team has been assembled bringing together the proven expert teams of TAKE Life Sciences and WCI Consulting and, adding to this core, a range of experts from the worlds of Clinical Development, Regulatory, Technology, and Consulting.  We have built the Navitas team specifically to deliver insight to our clients, to develop pragmatic solutions together, and to support their deployment and operation. We deliver advise, solutions, and services in Clinical, Regulatory, Safety, and Content Management. We are proud that our legacy businesses have served the sector for some 20 years and have allowed us to work with 100 of the top Life Science companies. Our team have now grown to over 400 staff. Further details about Navitas are available at www.navitas.net.

     

    About Sparta Systems

    Founded in 1994, Sparta Systems is the world’s premier provider of cloud and on-premise quality management software. We offer the solutions, analytics, and expertise that speed up quality and compliance. Our solutions help to lower risk, increase efficiency, and keep consumers safe while allowing manufacturers, suppliers, and distributors to collaborate in a seamless and integrated environment. Sparta is privately owned and headquartered in Hamilton N.J, with offices across Europe and Asia. We support close to 1 million users across 700+ implementations, in more than 30 countries. Companies in life sciences, consumer products, discrete manufacturing and more, rely on Sparta.

 
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