Sparta Systems Partners with Navitas to Provide Comprehensive Solution for IDMP Compliance
HAMILTON, N.J. – Sept. 13, 2016 –Sparta 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 http://www.spartasystems.com.