Navitas' End-to-End Track & Trace DSCSA Solution
PRINCETON, N.J., Nov. 23, 2016 /PRNewswire/ --áNavitas demonstrated traceREADY«, its End-to-End Track&Trace and Edge solution for the Life Science industry at PharmaExpo in Chicago and the HDA (Healthcare Distribution Alliance) Traceability Seminar in Washington DC.
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Gartner listed Navitas' EDGE solution in its Market Guide for Track-and-Trace and Serialization Software Providers for Life Science Companies. The report highlighted the features of traceREADY with data management and governance, interoperability supply chain visibility, and integrated Edge functionality.
President Obama signed the Drug Supply Chain Security Act (DSCSA) into law in 2013. Prior to that, companies in the U.S. drug supply chain had to comply with multiple state-level requirements. The DSCSA replaces those laws with federal traceability requirements for prescription drugs across the country. Goals of the DSCSA include detecting unapproved, illegal, contaminated harmful drugs in aims to thwart the counterfeiting of prescription drugs, enabling verification of a drug product down to the level of individual packages and facilitating the speed and efficiency of the recall of drugs.
Life Science manufacturers, contract manufacturers, 3PLs (third party logistics providers), distributors, hospitals and pharmacies all will need to comply with new regulations, facing deadlines in the near term. The advent of serialization and DSCSA compliance begins in November of 2017. Products and materials that are not compliant will be required to be stopped in process.
traceREADY is currently being implemented at many manufacturers and third-party logistics (3PL) providers globally, ultimately being used in over 50 sites throughout the world.
Navitas' traceREADY« platform provides next generation mobility for extended ERP transactions and other enterprise applications and operates on iOS and Android devices, as well as Windows operating systems. traceREADY allows companies to manage global regulatory compliance, diversion detection, product recalls and anti-counterfeiting efforts across the supply chain by managing serialized and non-serialized products. It also makes it easy to give internal and external trusted parties access to product identification, location, serialization and event data at any point in the delivery supply chain. Built on an EPC Information Services (EPCIS), GS1 EPCglobal-certified standards-based framework, traceREADY provides end-to-end transparency, logistics management and product ID verification services companies need to optimize all of their track-and-trace initiatives.
Life science companies can save up to 30-40% on implementation costs and the traceREADY platform offers a quick implementation phase (16-24 weeks) complimented by a unique process assessment exercise that insures quick user adoption and requires minimal change management. For more information, visit www.traceready.com.
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 advice, solutions, and outsourcing services in Clinical, Regulatory, Safety, and Content Management.
We are proud that our legacy businesses have served the sector for over 20 years and have allowed us to work with 100 of the top Life Science companies. Our team has now grown to over 500 staff. For more information, visit www.navitas.net.
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