Press Releases

TraceLink Supports New GS1 Healthcare US Guideline for DSCSA Serialization

November 15, 2016

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 support of the newly published GS1 US guideline, “Applying GS1 Standards for DSCSA and Traceability (R1.2),” to help the pharmaceutical industry prepare for Drug Supply Chain Security Act (DSCSA) serialization requirements. Elizabeth Waldorf, Director, Global Traceability and Standards at TraceLink, was one of the two technical editors of the new GS1 US guideline.

The TraceLink Life Sciences Cloud supports the use of GS1 Electronic Product Code Information Service (EPCIS) between internal systems and trade partners at the packaging line, enterprise, and network levels, offering flexible integration and data translation and transport capabilities. Through TraceLink’s proven network solution, customers can seamlessly exchange both EPCIS data, HDA ASN and other data formats between both their own systems and with trade partners regardless of format discrepancies or differing transport preferences, allowing them to seamlessly achieve both business efficiencies and partner interoperability. The adoption of the EPCIS standard in the Life Sciences Cloud now lays a secure foundation for the efficient exchange of serialization data and events to support DSCSA serialization and verification requirements across the supply chain.

“The release of this new guideline is the result of a two-year collaboration and commitment from the members of the GS1 Healthcare US Secure Supply Chain Workgroup. TraceLink played a critical role in helping to define this latest release and we are grateful for the involvement by Elizabeth Waldorf of TraceLink, who was a key contributor as the technical editor of the new GS1 US 1.2 DSCSA and Traceability guideline,” said Peter Sturtevant, Senior Director, Industry Development, Pharmaceuticals, GS1 US. “We look forward to continuing our work with all of the Workgroup members to determine how the EPCIS standards can continue to be applied to best support DSCSA serialization and traceability.”

“TraceLink’s long-standing support of EPCIS and steadfast relationship with GS1 US spans across many years and global markets, due to our shared alignment on ensuring that the pharmaceutical supply chain can exchange and manage the massive volume of data and transactions expected to occur as global markets transition to serialization,” said Shabbir Dahod, president and CEO of TraceLink. “We’re proud of our ongoing alliance with GS1 US and look forward to optimizing the Life Sciences Cloud with this latest GS1 US 1.2 DSCSA and Traceability guideline to continue interoperability with GS1 Standards.”

With four active members of the GS1 Healthcare US Secure Supply Chain Workgroup, TraceLink leaders began the partnership with GS1 over a decade ago, delivering on a series of industry-first EPCIS and GS1 milestones, including:

  • Executing on the first GS1 EPCIS 1.1 data exchange pilot for DSCSA compliance on the Life Sciences Cloud, conducted between a top-5 pharmaceutical manufacturer and one of the “big three” wholesale distributors in the U.S.
  • Unveiling the first life sciences compliance solution to adopt EPCIS-based implementation guidelines for Brazil in August 2015;
  • Winning the 2015 GS1 Brazil Automation Award for its partnership with Roche and SPI, which connected Roche to over a dozen supply chain partners on the Life Sciences Cloud using the GS1 EPCIS 1.1-based standard; and,
  • Leading development and publication of the EPCIS 1.1-based GS1 Brazil Medicine Traceability Guideline with Elizabeth Waldorf as both workgroup co-chair and document editor for the data exchange standard;
  • Becoming the first company in the life sciences industry to support large-scale commercial EPCIS deployments of more than 69,000 serialized shipments in September of 2011; and
  • Acknowledging Lucy Deus, vice president of product management at TraceLink, as the 2007 EPCglobal Person of the Year. Lucy was also technical editor of the Drug Pedigree Messaging Standard.

 



Download Article

Stay Informed