The pharmaceutical supply chain faces a persistent challenge: being “GS1-aligned” does not always mean a system has been independently validated against the standard.
GS1 certification is emerging as a critical distinction for companies seeking to demonstrate genuine DSCSA conformance rather than mere alignment with broadly interpreted guidelines.
GS1 established a conformance testing certification program specifically to identify non-conformances and improve DSCSA traceability and interoperability across the pharmaceutical supply chain.
The program was built around requirements for a reliable, scalable, and robust testing and certification service capable of handling the complexity of modern pharmaceutical distribution networks.
Rigorous testing benchmarks were developed by a GS1 US working group to ensure common assessments of similarly constructed traceability scenarios across participating organisations.
The certification framework allows independent companies, such as Gateway Checker, to be recognised as a Conformance Testing Service, providing an authoritative and objective assessment of EPCIS data quality.
As a result of this structure, creative or self-serving interpretations of the standard can be supplanted with facts and an unambiguous assessment of whether a system truly conforms.
Körber’s STEPLogic Trace 9.1 has achieved GS1 standards certification through Gateway Checker, confirming that it produces EPCIS data conformant with GS1 Global Standards.
That certification supports interoperable, standards-based traceability for pharmaceutical supply chains, giving trading partners greater confidence in the data they receive and exchange.
Gateway Checker serves as an independent certification authority, validating EPCIS conformance through structured testing scenarios designed to ensure data interoperability across trading partners.
GS1 US also launched the GS1 US Rx EPCIS Conformance Testing Program to support the pharmaceutical industry in implementing EPCIS to meet DSCSA data exchange requirements.
Conformance testing validates that an EPCIS event file follows the industry-suggested format and structure for serialised item data exchange, a crucial step toward supply chain transparency.
The foundation of DSCSA’s data language is a GS1 standard called Electronic Product Code Information Services, commonly referred to as EPCIS, which has become the de facto industry standard.
Notably, nothing in FDA regulations mandates the use of GS1 or EPCIS, yet the serialisation and traceability industry has converged on EPCIS because it is more effective and efficient for tracking serialised items.
When all trading partners use a common communication format, the entire supply chain benefits from reduced errors, faster reconciliation, and stronger end-to-end visibility from manufacturer to dispenser.