Guidelines expected to assist companies with EPCIS-based sTI/TS data exchange as they prepare to meet November DSCSA deadlines.
TraceLink Inc., a digital network platform company that works extensively with members of the pharma supply chain, is continuing its support of Drug Supply Chain Security Act (DSCSA) 2023 readiness through its partnership with GS1 in the authoring of the GS1 US Addendum Guidance and XML Examples for GS1 US DSCSA Implementation Guideline R1.3. The platform company has exchanged over one million DSCSA-compliance EPCIS transactions between trading partners on the TraceLink network, with over 1,075 companies now being EPCIS-enabled for DSCSA compliance data exchange in preparation for November 2023 deadlines.
The latest implementation documents, published by GS1 US on May 26, are intended to serve as an EPCIS serialized data exchange implementation blueprint for companies across the US pharma and healthcare supply chain. The expanded documentation provides detailed descriptions of end-to-end trading partner event choreographies for serialized item traceability use cases under DSCSA.
“Given the sense of urgency for November 2023, we want to jumpstart EPCIS implementations and demystify the technical "‘wirings’" for orchestrating DSCSA exchanges for the industry's most common supply chain choreographies," notes Elizabeth Waldorf, director, global traceability and standards for TraceLink and member of the GS1 Healthcare US executive leadership committee.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.
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