GS1 US Rx EPCIS Conformance Testing Program

Members of the U.S. pharmaceutical industry have been preparing their systems and business processes to meet Drug Supply Chain Security Act (DSCSA) requirements. Many in the U.S. pharmaceutical industry have chosen to use Electronic Product Code Information Services (EPCIS) to support their DSCSA data exchange implementation, which enables trading partners to share information about the physical movement and status of products.

To support their work, industry approached GS1 US about establishing a program to evaluate EPCIS messages for their conformance to the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability. The goal is to support and streamline trading partner on-boarding with a mechanism to provide a level of confidence about readiness, implementation quality and consistency.

What is GS1 Rx EPCIS?

The GS1 US Rx EPCIS Conformance Testing Program is a voluntary program offered to support pharmaceutical industry members implementing EPCIS for DSCSA and traceability pursuant to the GS1 US Implementation Guideline. The Program is designed to validate that an EPCIS event file follows the format and structure defined in the GS1 US Implementation Guideline to support interoperable EPCIS baseline functionality for the purposes of serialized item data exchanges. It is designed for the sender of EPCIS events (whether the company\themselves, or a solution provider on their behalf), also known as “EPCIS event generators.” (Note: the program is not designed for receivers of events.)

  • Pharmaceutical supply chain members who will exchange EPCIS events pursuant to the GS1 US Implementation Guideline
  • Companies that will generate EPCIS events pursuant to the GS1 US Implementation Guideline
  • Solution Providers (on behalf of a manufacturer, wholesaler or distributor)

GS1 US will certify third-party testing services to administer the conformance tests (“certified conformance testing service”). GS1 US will oversee the program and award GS1 US Conformance Trustmarks to EPCIS event generators for each role-based test scenario they pass.

GS1 US Rx EPCIS Testing Service Certification Program Pricing Structure

  • All GS1 US Rx EPCIS Testing Service Certification Program companies must be members in good standing in the GS1 US Solution Partner Program.
  • The GS1 US Rx EPCIS Testing Service Certification Program has an initial certification fee of $5,000.
  • If a re-test is required, the re-testing fee will be $2,000.

To learn more about EDI and become a certified EDI Professional please visit our course schedule page.

Leave a Reply

Your email address will not be published.

Post Navigation