Table of contents
Overview
The EPCIS 1.2 – SOM Product Release transaction is an XML-based message used to communicate that serialized pharmaceutical products have passed quality review and other checks and are authorized for release into the supply chain. This transaction complies with GS1 EPCIS 1.2 standards and ensures that serialized units are traceably released.
With TraceLink’s Opus Platform and B2N Integrate-Once™ architecture, the SOM Product Release transaction enables secure, real-time notification of release decisions to downstream systems and trading partners—supporting DSCSA readiness, DEA compliance, and internal quality protocols.re data exchange, and auditable documentation of internal destruction decisions.
Key Use Cases
- Confirm that serialized products have passed internal product release SOPs and are approved for shipment.
- Notify internal systems and external partners of release authorization.
- Enable downstream fulfillment, ASN generation, and product movement.
- Maintain compliance with DSCSA and DEA expectations for product control documentation.
- Provide a traceable audit trail for serialized product release decisions.
Data Elements Included
An EPCIS 1.2 – SOM Product Release transaction includes:
- Event Type: ObjectEvent or AggregationEvent indicating product readiness.
- Serialized Product Identifiers (EPCs): SGTINs representing approved units.
- Event Time and Time Zone: Timestamp of the release decision.
- Business Step: Typically “shipping” or “release_for_distribution”.
- Disposition: Product status (e.g., “released”, “available”).
- Read Point and Business Location: Where the SOM clearance occurred.
- SOM Evaluation Result: Indicates pass status.
- Business Transaction Reference: PO number, shipment ID, or order number.
- Digital Signature (optional): For data integrity and non-repudiation.
- Comments or Notes: Optional fields for internal documentation.
Benefits of EPCIS 1.2 – SOM Product Release
- Ensures operational and regulatory compliance by controlling and documenting product release.
- Provides secure, auditable proof of quality control processes for serialized units.
- Enables automation of downstream fulfillment workflows post-clearance.
- Improves operational efficiency by digitally integrating product release processes with serialization and logistics systems.
- Enhances traceability with structured EPCIS 1.2 event data.
How TraceLink Supports EPCIS 1.2 – SOM Product Release
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, enables secure and compliant release of serialized products by:
- Integrating with packaging, material handling, and serialization systems to trigger release events.
- Capturing EPCIS 1.2-compliant release data with full serialization context.
- Transmitting release notifications to trading partners, 3PLs, and internal systems.
- Providing dashboards and audit trails to track product release decisions.
- Ensuring secure, standards-based data exchange across the digital supply network.
Explore More Serialization & Compliance Capabilities
- SOM Receipt: Confirm serialized product shipment receipt.
- SOM ESM Decommission: Deactivate serialized products.
- DSCSA ASN: Share serialized shipment data for DSCSA compliance.
- SOM ESM Sales Shipment: Record serialized shipments once product release authorization is received.
Need Help Implementing EPCIS 1.2?
Contact usto learn how our OPUS Platform and B2N Integrate-Once™ model can help you automate product release workflows, ensure DSCSA/global compliance, and maintain full traceability across your pharmaceutical supply chain.
