Table of contents
Overview
The EPCIS 1.2 – SOM ESM Decommission transaction is an XML-based message used to decommission serialized pharmaceutical products that require removal from the supply chain for compliance, quality, or operational reasons. This transaction is initiated through TraceLink’s Enterprise Serialization Management (ESM) system and complies with GS1 EPCIS 1.2 standards.
With TraceLink’s Opus Platform and B2N Integrate-Once™ architecture, the SOM ESM Decommission transaction ensures that serialized units are securely and accurately marked as decommissioned across all integrated systems and trading partners—supporting full traceability, DSCSA compliance, and internal quality control.
Key Use Cases
- Decommission and remove serialized products from inventory due to quality issues, recalls, or regulatory holds.
- Update product status in the serialization repository and across connected partners.
- Maintain a complete audit trail of serialization lifecycle events.
- Ensure DSCSA/global track and trace and DEA compliance by formally deactivating flagged EPCs.
- Support internal product disposition policies through ESM workflows.
Data Elements Included
An EPCIS 1.2 – SOM ESM Decommission transaction includes:
- Transaction Type: SOM ESM Decommission (specific to internal ESM-triggered deactivation).
- Serialized Product Identifiers (EPCs): SGTINs (Serialized Global Trade Item Numbers) representing the units being decommissioned.
- Decommission Trigger Source: Indicates whether the decommission was initiated due to SOM alert, QA rejection, expiration, or business exception.
- Lot and Batch Information: Associated lot number, expiration date, and product code (GTIN).
- Event Time and Time Zone: Timestamp of when the decommission event was triggered in ESM.
- Business Step: Typically “decommissioning” to reflect removal from the supply chain.
- Disposition: Final status of the product (e.g., “quarantined”, “disposed”, “recalled”, “rejected”).
- Business Location and Read Point: Facility or system where the decommission was recorded.
- Reason Code: Categorized reason for deactivation (e.g., “SOM_RISK_FLAG”, “QA_REJECTED”).
- User or System Identifier (optional): Who or what system initiated the decommission.
- Audit Reference ID (optional): Internal reference for audit tracking or compliance review.
- Digital Signature (if applicable): For ensuring authenticity and regulatory-grade integrity.
Benefits of EPCIS 1.2 – SOM SEM Decommission
- Ensures serialization compliance by securely deactivating flagged EPCs.
- Supports DSCSA and DEA requirements for product removal and traceability.
- Maintains a complete audit trail of serialization lifecycle events.
- Synchronizes decommission status across internal systems and external partners.
- Improves operational processes and helps eliminate errors by integrating with WMS and quality systems.
How TraceLink Supports EPCIS 1.2 SOM ESM Decommission
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, enables secure, compliant, and efficient decommissioning through ESM by:
- Triggering decommission events with Serialized Operations Manager based on QA holds or business rules.
- Capturing EPCIS 1.2-compliant decommissioning events from ESM workflows.
- Distributing decommission data to serialization repositories, trading partners, and regulatory systems.
- Providing dashboards and reports for tracking decommissioned EPCs and their rationale.
- Ensuring secure, standards-based data exchange with full auditability.
Explore More Serialization & Compliance Capabilities
- EPCIS Serialization: Record and share commissioning events at unit, case, or pallet level for regulatory compliance.
- SOM Receipt: Confirm serialized product receipt.
- DSCSA ASN: Share serialized shipment data for downstream verification.
- SOM Void Shipment: Cancel completed shipments — impacted serialized units are typically decommissioned.
Need Help Implementing EPCIS 1.2?
Contact us to learn how our OPUS Platform and B2N Integrate-Once™ model can help you automate serialized product decommissioning and maintain traceability across your global life sciences and healthcare supply chain.
