TRACEABILITY
3 EPCIS Data Exchange Issues in Pharma Traceability KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1. The global GS1 standard, EPCIS, offers a common information exchange language.
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2. In AmerisourceBergen’s initial testing, nearly every EPCIS file had data issues.
harma companies continue to make inroads to meet the DSCSA 2023 requirement for unit-level traceability at each change of ownership between trading partners. “Capturing and exchanging information at this level of specificity requires a common information framework,” explained Gary Lerner, president at Gateway Checker Corporation, at the GS1 Connect: Digital Edition virtual conference in June. “This information framework captures what happens in the physical world with an electronic twin, essentially an information encoded representation of packing and shipping events that can be exchanged with trading partners. What’s needed to accomplish that is a common vocabulary and structure that enables trading partners
3. Conformance testing services have emerged to cut down on wasted back-and-forth.
to then share and exchange essential trading information in a consistent, accurate, and interoperable manner,” said Lerner. Without a common standardized approach, there will be considerable waste in time and effort with trading partners negotiating the structure and content in each point of connection.
EPCIS Lerner pointed to the value of the global GS1 standard, EPCIS (Electronic Product Code Information Services), which enables the common information exchange language that can be shared. “However, EPCIS is a general purpose exchange standard. Application-specific standards are therefore necessary to tailor EPCIS to July/August 2020 • Healthcare Packaging | 27
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