Table of contents
Overview
The EPCIS 1.2 – DSCSA ASN (Advance Ship Notice) is an XML-based electronic message used to transmit serialized product shipment data in compliance with the Drug Supply Chain Security Act (DSCSA). The transaction includes serialized EPCIS events (such as commissioning, aggregation, and shipping) that represent the movement of pharmaceutical products through the supply chain.
With TraceLink’s OPUS Platform and B2N Integrate-Once™ architecture, the DSCSA ASN using EPCIS 1.2 following GS1 standards enables secure, standardized, and interoperable exchange of serialized data between trading partners ensuring full compliance with DSCSA regulations and improving end-to-end supply chain traceability.
Key Use Cases
- Transmit serialized shipping event data from manufacturers or 3PLs to wholesale distributors.
- Fulfill DSCSA requirements for interoperable product tracing at the package level.
- Enable downstream partners to verify serialized product upon receipt.
- Provide full aggregation hierarchy (pallet → case → unit) in a machine-readable format.
- Link serialized data to business transactions such as purchase orders or invoices.
- Support onboarding and compliance across multi-tier pharmaceutical supply networks.
Data Elements Included
An EPCIS 1.2 – DSCSA ASN (Advance Ship Notice) transaction includes:
- Event Types: ObjectEvent, AggregationEvent, and/or ShipmentEvent.
- EPCs (Electronic Product Codes): Serialized identifiers (SGTINs) for units, cases, and pallets.
- Parent-Child Relationships: Aggregation hierarchy for serialized containers.
- Event Time and Time Zone: Timestamp of the event occurrence.
- Read Point and Business Location: Where the event physically occurred.
- Disposition: Product state (e.g., “in_transit”, “available”).
- Business Transaction References: PO number, invoice ID, or shipment reference.
- Sender and Receiver GLNs: Global Location Numbers for both parties.
- DSCSA-Specific Extensions: Optional fields for verification, lot, expiration, and TI/TS data.
Benefits of EPCIS 1.2 – DSCSA ASN (Advance Ship Notice)
- Ensures DSCSA compliance through interoperable serialized data exchange.
- Enables downstream verification of serialized product at the package level.
- Supports secure, standards-based communication using EPCIS 1.2 XML schema.
- Improves traceability and audit readiness with serialized shipment records.
- Automates data exchange with multiple trading partners using a single standard.
- Scales across the U.S. pharmaceutical supply chain with TraceLink’s B2N Integrate-Once™ model.
Business Process: EPCIS 1.2 – DSCSA ASN (Advance Ship Notice)
- Serialization & Aggregation: Products are serialized and optionally aggregated into cases and pallets. EPCIS events (commissioning, aggregation, shipping) are captured.
- TI/TS Data Generation: Transaction Information (TI) and Transaction Statement (TS) are created, containing DSCSA-required product and compliance details.
- ASN Creation: EPCIS 1.2 ASN is generated, combining serialized event data with TI/TS, and optionally Transaction History (TH).
- Secure Transmission: The ASN is securely sent to the downstream partner using TraceLink’s B2N Integrate-Once™ network in DSCSA-compliant EPCIS XML format.
- Partner Verification: The receiving partner verifies EPCs and TI/TS data before accepting the shipment into inventory.
- Compliance Logging: All events and documents are logged for DSCSA audit readiness and regulatory reporting.
How TraceLink Supports EPCIS 1.2 – DSCSA ASN (Advance Ship Notice)
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, delivers a secure, scalable, and DSCSA-compliant EPCIS data exchange solution:
- Generating EPCIS 1.2 ASNs with required TI, TS, and optional TH data.
- Automating end-to-end DSCSA workflows from packaging to shipment.
- Delivering serialized data to downstream partners via secure, interoperable channels.
- Supporting digital signatures and secure transport protocols for DSCSA compliance.
- Providing dashboards to monitor ASN delivery, partner acknowledgements, and verification readiness.
- Enabling rapid onboarding of trading partners across the DSCSA network.
Explore More Serialization & Compliance Capabilities
- EPCIS Serialization: Capture and transmit commissioning events for units, cases, and pallets.
- Serialized Shipments: Record and share serialized outbound movements across the supply chain.
- SOM Receipt: Confirm serialized product receipt and verification against the ASN.
- HDA ASN: Comply with HDA guidelines for serialized shipment data.
Need Help Implementing EPCIS 1.2?
Contact us to learn how our OPUS Platform and B2N Integrate-Once™ model can help you automate serialized data exchange, achieve DSCSA compliance, and build a secure, interoperable pharmaceutical supply chain.
