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TraceLink, Roche and SPI Win GS1 Brazil Automation Award for RDC 54 Compliance Pilot

November 24, 2015

TraceLink Inc., the world’s largest track and trace network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, today announced that the company has been awarded the 2015 GS1 Brazil Automation Award for its partnership with Roche and SPI in developing an ANVISA pilot solution to meet the Brazil RDC 54 track and trace regulation. TraceLink, Roche and SPI were recognized for their innovation and entrepreneurship in creating practical solutions based on industry standards to meet key business challenges at the GS1 Brazil award ceremony on November 11th in Sao Paulo Brazil.

“With the large scale and diverse scope of our pharmaceutical supply operations in Brazil, it was very important for us to implement a pilot program with very experienced solution partners to securely meet initial 2015 regulatory requirements while creating a strong foundation for full implementation across all of our products and supply chain relationships. This work reflects Roche's commitment to patient safety,” said Hamilton Nogueira, IT Director of Roche Pharma Brazil. “We were pleased to work with such knowledgeable and skilled partners from TraceLink and SPI to design and deploy the ANVISA pilot in a very short timeline. The TraceLink Life Sciences Cloud’s support for open standards made integration much easier and TraceLink’s comprehensive track and trace platform gives us confidence to meet Brazil’s evolving regulatory requirements for the future.”

“Companies implementing solutions to meet Brazil’s serialization and traceability regulations face complex and evolving data management, business process support and supply chain integration requirements,” said Rafael Schirmer, Director at SPI. “The decision to partner with TraceLink to meet these challenging regulations was an easy one. TraceLink’s proven global track and trace platform, with its extensive built-in capabilities for all facets of serialization, product tracking and government reporting combined with its ease of configuration and implementation, help companies of all sizes and network complexities cost-effectively meet Brazil’s regulations with assurance.” 

Brazil has instituted one of the most challenging track and trace regulations across the world, with complex serialization, product tracking and government reporting impacting all stakeholders serving the Brazil supply chain from multinational pharmaceutical companies to local pharmacy dispensers. Pharmaceutical companies serving the Brazil market are faced with diverse operational and technical challenges including generation, application and management of unique Brazil serialization identifiers on each unit of medicine, to tracking and capturing product movements internally and into the supply chain, and reporting serialization and transaction information to Brazil’s ANVISA regulators. To help prepare for these fast approaching regulations, TraceLink collaborated with its strategic partner SPI and the Roche Brazil team to quickly develop a comprehensive Brazil pilot solution based on GS1 standards for serialization and traceability. 

“Ensuring all patients have access to safe medicines is a key mission for TraceLink and a major driver for the development of our Life Sciences Cloud platform,” said Shabbir Dahod, president and CEO of TraceLink. “We are honored that GS1 Brazil has recognized TraceLink, Roche, and SPI with this award, and proud that we’re able to help pharmaceutical companies like Roche demonstrate how they are protecting product integrity and meeting emerging track and trace regulations in Brazil with GS1 standards.”

“Implementation of Brazil’s track and trace regulations will transform how the Brazil pharmaceutical supply chain operates, requiring tight coordination between tens of thousands of companies producing and distributing billions of drug products annually in Brazil,” said Patrícia Amaral, Business Advisor of GS1 Brazil. “The use of a common set of technology and open information standards such as the Brazil Medicine Traceability Guidelines using GS1 EPCIS is critical in helping companies connect to and share information across their diverse supply chain ecosystem. The partnership between TraceLink, Roche and SPI exposed how a standards-based network application platform can be deployed in a tight timeframe to meet complex and continually evolving requirements.”

To learn more about meeting Brazil track and trace regulations and how to build a flexible serialization, track and trace, and reporting platform for the US, the EU, China, Brazil, Germany, South Korea, India, Turkey, Argentina and other countries, please visit www.tracelink.com.



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