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The GS1 US Rx EPCIS Conformance Testing Program is a voluntary program offered to support pharmaceutical industry members who are implementing EPCIS for DSCSA and traceability. 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.
If you’re a third-party testing service, you can become certified by GS1 US to administer the conformance tests (“certified conformance testing service”). As a certified conformance testing service, you’ll be able to conduct conformance testing for all test scenarios.
*For information about the act, see the 2013 Drug Supply Chain Security Act
**For more information, see the U.S. FDA Guidance for Industry: DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (November 2014)
Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA.
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