Compliance

Outbound EPCIS XML Files: Ensuring DSCSA Compliance

Compliance

Moving serialized pharmaceuticals through a humanitarian supply chain means meeting the Drug Supply Chain Security Act (DSCSA) at every step. HELM now generates outbound EPCIS XML files automatically, so compliance and transparency travel with every shipment.

Why EPCIS matters

EPCIS (Electronic Product Code Information Services) is the standard format for sharing serialization events — what happened, where, and when — across trading partners. Outbound EPCIS files let HELM:

  • Document the chain of custody for serialized product.
  • Share verifiable shipment data with downstream partners.
  • Meet DSCSA requirements without manual reconciliation.

For medical missions and pharmaceutical distributors, that means full supply-chain transparency built into the workflow — not bolted on afterward.