TraceLink Attains Gateway Certified for GS1 US Pharmaceutical Traceability Scenarios

Published August 27th, 2024

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Gateway Checker™, the leading provider of GS1 Certified Conformance Testing Services, applauds TraceLink’s recent attainment of GS1 US Conformance Trustmarks and Gateway Certified™ accreditation.

The Gateway Certified™ accreditation program provides independent, objective testing and conformance certification for entities seeking to comply with enhanced drug distribution security requirements. Such requirements are mandated under the FDA Drug Supply Chain Security Act (DSCSA).

Users of Gateway EPCIS Verify can automatically apply for a GS1 US Trustmark after fulfilling Pharmaceutical Traceability Scenario (PTS) requirements and earning a Gateway Certificate.

TraceLink, as the first solution provider to attain Gateway Certified for all 16 PTS use cases, demonstrates a commitment to GS1 Application Standards and DSCSA interoperability that is currently unmatched by its peers.

“Despite the necessity for alignment on information content and adherence to EPCIS application standards, it is our understanding that few other solution providers have demonstrated the confidence or commitment to subject their solutions to independent and impartial testing”, said Gary Lerner, President of Gateway Checker Corporation. “We encourage all solution providers, pharmaceutical manufacturers, and wholesalers interested in attaining DSCSA compliance and information interoperability to join the Gateway Certified™ program.”

Learn About the Gateway Certified Program

The GS1 US Rx EPCIS Conformance Testing Program ensures pharmaceutical supply chain integrity and facilitates information interoperability and compliance of data exchanges as mandated by DSCSA.

For a complimentary EPCIS and VRS conformance evaluation, get tested by an independent, certified testing service.

Be Confident, Get Certified.

 

Gateway Certified Seal, signaling accreditation attainment for GS1 US Pharmaceutical Traceability Scenarios