TraceLink Becomes First Solutions Provider to Achieve All 16 GS1 US Conformance Trustmarks for EPCIS File Support Page 1

BOSTON, August 26, 2024 /PRNewswire/ — TraceLink, the largest end-to-end digital network platform for intelligent orchestration of the life sciences and healthcare supply chain, is proud to announce that it is the first and only solution provider to have secured all 16 GS1 US Conformance Trustmarks for EPCIS file support. These trustmarks certify that a company’s systems meet strict criteria for accurately and securely exchanging traceability data, and ensure compliance with the Drug Supply Chain Security Act (DSCSA) requirements for tracking and tracing prescription drugs through the supply chain. This milestone sets a new industry standard in the U.S. pharmaceutical supply chain’s efforts to meet DSCSA requirements.

This comprehensive certification includes 7 Trustmarks that support manufacturers with downstream trading partners and 9 Trustmarks that assist wholesalers with dispensers. Achieving all available Trustmarks underscores TraceLink’s commitment to excellence and compliance in the pharmaceutical industry, and provides assurance that the EPCIS messages sent on behalf of our customers – manufacturers, wholesalers and dispensers – fully comply with the application standards set by GS1 US, publisher of the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability, Release 1.2. This ensures that TraceLink customers can seamlessly track and trace their products, reducing operational risk, improving supply chain transparency and ultimately improving patient safety.

Focused on standards and compliance

The GS1 US Rx EPCIS Conformity Testing Program plays a critical role in the pharmaceutical supply chain, ensuring the interoperability and compliance of data exchanges required by the DSCSA.

“TraceLink’s commitment to standards has been a cornerstone of our mission for more than 15 years,” said Shabbir DahodPresident and CEO of TraceLink. “Our active participation and leadership in several standards working groups, such as the GS1 US Healthcare Executive Leadership Team, GS1 Global Healthcare Leadership Team, and the GS1 Global Architecture Team, demonstrate our commitment to driving mass adoption and interoperability across the supply chain. Our own Elizabeth WaldorfDirector of Global Traceability and Standards, co-chaired the GS1 US RxSecureSupplyChain Workgroup and the GS1 EPCIS/CBV Standard MSWG and Visibility Standards Mission Group and was also recognized with the 2022 GS1 Ken Traub Industry Award. Our continued investment in these initiatives is critical to ensuring the delivery of safe, effective, and authentic medicines to patients worldwide.”