Table of contents
Overview
The EPCIS 1.2 – HDA ASN (Advance Ship Notice) is an XML-based electronic message that provides detailed, serialized shipment information from pharmaceutical manufacturers or distributors to downstream trading partners in compliance with Healthcare Distribution Alliance (HDA) and DSCSA (Drug Supply Chain Security Act) guidelines. It includes EPCIS-compliant event data such as shipping, commissioning, and aggregation of serialized units.
With TraceLink’s OPUS Platform and B2N Integrate-Once™ architecture, the EPCIS 1.2 HDA ASN enables real-time, interoperable data exchange between trading partners, ensuring compliance, improving traceability, and enhancing supply chain security for serialized pharmaceutical products.
Key Use Cases
- Transmit serialized shipping event data from manufacturers or 3PLs to wholesale distributors.
- Comply with DSCSA requirements for interoperable exchange of serialized product data.
- Support HDA guidelines for EPCIS-based ASNs in the U.S. pharmaceutical supply chain.
- Enable downstream verification of serialized products upon receipt.
- Provide full aggregation hierarchy (pallet → case → unit) for serialized shipments.
- Facilitate secure, real-time integration with trading partners and regulatory systems.
Data Elements Included
An EPCIS 1.2 – HDA ASN (Advance Ship Notice) transaction includes:
- Event Type: Shipping or commissioning events (ObjectEvent, AggregationEvent).
- EPC Identifiers: Serialized GTINs (SGTINs) for each unit, case, or pallet.
- Parent-Child Aggregation: Hierarchical relationships between serialized containers and contents.
- Event Time and Time Zone: When the event occurred.
- Read Point and Business Location: Where the event took place (e.g., shipping dock, warehouse).
- Disposition: Indicates the business state of the product (e.g., “in_transit”).
- Business Transaction References: PO numbers, shipment IDs, or invoice references.
- Sender and Receiver GLNs: Identifiers for trading partners involved in the transaction.
- DSCSA Compliance Fields: Optional extensions for regulatory traceability and verification.
Benefits of EPCIS 1.2 – HDA ASN (Advance Ship Notice)
- Ensures DSCSA compliance through interoperable serialized data exchange.
- Enables full traceability with parent-child aggregation of serialized units.
- Automates shipment verification at the receiving site using serialized EPC data.
- Supports secure, standards-based communication using EPCIS 1.2 XML schema.
- Improves inventory accuracy and product visibility across the supply network.
Business Process: EPCIS 1.2 – HDA ASN (Advance Ship Notice)
- Serialization & Aggregation: Serialized units are commissioned and aggregated (unit → case → pallet) at the manufacturer or 3PL.
- Shipment Event Capture: Shipping events are recorded, including EPCs, read point, business location, and aggregation hierarchy.
- ASN Generation: EPCIS 1.2-compliant events are compiled into an HDA-compliant ASN using TraceLink’s Opus Platform.
- Data Transmission: The ASN is securely sent to the receiving distributor via TraceLink’s B2N Integrate-Once™ network.
- Partner Verification: The receiving partner uses the ASN to verify serialized contents upon delivery and update inventory.
- Compliance Logging: All events are logged for DSCSA compliance, audit readiness, and supply chain visibility.
How TraceLink Supports EPCIS 1.2 – HDA ASN (Advance Ship Notice)
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, enables secure, scalable, and DSCSA-compliant EPCIS data exchange by:
- Integrating with serialization, ERP, WMS, and logistics systems to generate EPCIS events.
- Transmitting EPCIS 1.2-compliant ASNs to wholesale distributors and trading partners.
- Ensuring data integrity and security through digital signatures and secure transport protocols.
- Providing dashboards and audit trails for shipment status, verification, and compliance tracking.
- Supporting rapid partner onboarding with a single connection to the TraceLink network.
Explore More Serialization & Compliance Capabilities
- DSCSA ASN: Transmit serialized Advance Ship Notices with embedded TI/TS data for DSCSA compliance.
- EPCIS Serialization: Record and share commissioning events at unit, case, or pallet level for regulatory compliance.
- Serialized Shipments: Capture and communicate serialized product movement across the supply chain.
- SOM Product Release: Confirm SOM evaluation clearance and authorize serialized products for shipment.
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, comply with DSCSA requirements, and enhance supply chain visibility across your pharmaceutical network.
