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.”
The Navitas team (navitas.net) 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.
About Sparta Systems
Sparta Systems (spartasystems.com), an industry pioneer and global leading provider of enterprise quality management software (EQMS) solutions, enables businesses to safely and efficiently deliver their products to market. Its TrackWise EQMS, a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. Headquartered in Hamilton, N.J. and with locations across Europe and Asia, Sparta Systems maintains an extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing and consumer products markets.
Contact: Sara LaFauci - SHIFT Communications for Sparta Systems