DSCSA Drug Traceability (EPCIS)
DSCSAfree10 data-quality rules for Drug Supply Chain Security Act (DSCSA) interoperable traceability, exchanged as GS1 EPCIS events. Covers required EPCIS event fields, GTIN/serial (SGTIN) format, lot and expiry, bizStep and disposition value sets, trading-partner GLNs, aggregation consistency, and duplicate-EPC suppression. Use it to validate EPCIS data before partner exchange or verification.
Checks included (10)
Required EPCIS Event Fields Present
Each EPCIS event must carry an EPC, event time, bizStep, and disposition.
Serial Number Present(serial_number)
Item-level (SGTIN) events must carry a serial number; DSCSA requires unit-level serialization.
Lot and Expiry Present
Each saleable unit must report its lot number and expiration date.
GTIN Is 14 Digits(gtin)
The product GTIN must be a 14-digit GS1 identifier.
Business Step Is Valid(biz_step)
bizStep must be a CBV business step (commissioning, packing, shipping, receiving, decommissioning).
Disposition Is Valid(disposition)
disposition must be a CBV disposition (active, in_transit, in_progress, destroyed, recalled).
Trading-Partner GLN Is Valid
The reading/business location GLN must be a known trading-partner GLN (13-digit GS1 location).
Aggregated Children Have a Parent
Every child EPC in an aggregation event must reference an existing parent (case/pallet) EPC.
No Duplicate EPC per Event Type(epc_event_key)
The same EPC should not appear twice for the same bizStep at the same time (duplicate commissioning/shipping).
Expiry Date After Event Date
A unit's expiration date should not precede the event date for active product in the supply chain.