FDA: Additional Time to Refine Systems and Processes for Interoperable Electronic Tracing
August 28, 2023

FDA: Additional Time to Refine Systems and Processes for Interoperable Electronic Tracing

Effective August 25, 2023: FDA issues new compliance policies to help supply chain stakeholders attain enhanced traceability under DSCSA. FDA recognizes that additional time beyond November 27, 2023 is necessary to “stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.” FDA is issuing this compliance policy to provide additional time, beyond […]
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Gateway Checker Introduces Gateway Certified<sup>TM</sup> Program to Support DSCSA Interoperability Requirements
August 24, 2023

Gateway Checker Introduces Gateway CertifiedTM Program to Support DSCSA Interoperability Requirements

Lexington, MA, August 28, 2023 – Gateway Checker, the industry’s leading GS1-certified conformance testing service, today announced the introduction of the Gateway Certification program. A “Gateway CertifiedTM” drug transaction report enables organizations to be confident that they are compliant, interoperable, and fully conform to industry and regulatory requirements. In November, all pharmaceutical trading partners will […]
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Antares Vision Group, through rfxcel, Joins the Gateway Certified™ Program to Lead VRS Standardized Testing Initiative
August 22, 2023

Antares Vision Group, through rfxcel, Joins the Gateway Certified™ Program to Lead VRS Standardized Testing Initiative

AV Group, which led an FDA-approved pilot to extend testing of the VRS, continues its DSCSA leadership by helping to test industry readiness. TRAVAGLIATO, BRESCIA, ITALY, August 22, 2023/EINPresswire.com/ — Antares Vision Group, an Italian multinational and a leading provider of track and trace and quality control systems, today announced that it has joined the […]
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Blue Link Partners with Gateway Checker to Help Pharma Distributors Meet DSCSA Interoperability Deadline
May 1, 2023

Blue Link Partners with Gateway Checker to Help Pharma Distributors Meet DSCSA Interoperability Deadline

Blue Link Associates and Gateway Checker are pleased to announce a new partnership that will help increase the security and stability of the pharmaceutical supply chain by providing robust software solutions to pharmaceutical wholesale and distribution customers.
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FDA recommends EPCIS for DSCSA drug traceability
July 6, 2022

FDA recommends EPCIS for DSCSA drug traceability

Happy Independence Day! After many years of uncertainty, FDA has (finally!) recommended that trading partners use the Electronic Product Code Information Services (EPCIS) standard to provide and maintain the data associated with transaction information and transaction statements. Prior regulations and guidance were less specific; only mandating that standards of interoperable exchange “shall comply with a […]
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