Table of contents
Overview
The SOM ESM Aggregation transaction is an XML-based message used to record the aggregation of serialized pharmaceutical product identifiers into parent containers (e.g., cases or pallets). Working in conjunction with Enterprise Serialization Management (ESM) platforms, this transaction complies with GS1 EPCIS 1.2 standards and ensures that aggregation events are traceable, secure, and compliant with DSCSA/global track and trace regulations and internal SOPs.
With TraceLink’s Opus Platform and B2N Integrate-Once™ architecture, the SOM ESM Aggregation transaction helps ensure that serialized units are accurately aggregated and linked to downstream supply chain events such as product release, shipment, or sampling.
Key Use Cases
- Document the parent-child relationship between serialized units and their containers.
- Ensure traceability of all aggregated products during shipments.
- Support track and trace compliance by linking aggregation events government reporting activities.
- Facilitate downstream actions such as product release, shipment, sampling, or decommissioning.
- Provide a secure, auditable record of aggregation events tied to flagged or cleared orders.
- Integrate aggregation data with ERP, WMS, and serialization repositories.
Data Elements Included
An EPCIS 1.2 – SOM ESM Aggregation transaction includes:
- Event Type: AggregationEvent
- Parent EPC: Serialized identifier of the parent container (e.g., case or pallet).
- Child EPCs: Serialized identifiers (SGTINs) of the units aggregated into the parent.
- Event Time and Time Zone: Timestamp of the aggregation event.
- Read Point: Location where aggregation occurred (e.g., packaging line, warehouse).
- Business Location: GLN of the facility performing the aggregation.
- Disposition: Status of the aggregated product (e.g., “packed”, “under_review”).
- Digital Signature (optional): For regulatory-grade data integrity.
- Comments or Notes (optional): Additional context for compliance or QA teams.
Benefits of EPCIS 1.2 – SOM ESM Aggregation
- Ensures serialized aggregation is compliant with serialization standards and track and trace requirements.
- Provides secure, traceable records of parent-child packaging relationships.
- Links aggregation events to compliance reporting and track and trace data exchange actions.
- Improves operational efficiency by automating aggregation capture within ESM workflows.
- Enhances traceability and audit readiness for regulatory inspections.
Business Process: EPCIS 1.2 – SOM ESM Aggregation
The SOM ESM Aggregation transaction is typically executed during the packaging, material handling, and inventory management phases:
- Serialized units are commissioned and prepared for shipment
- Units are aggregated into cases or pallets
- SOM ESM Aggregation (EPCIS 1.2) is triggered to record parent-child relationships
- Aggregated containers are released
- TraceLink logs the aggregation for downstream traceability and regulatory compliance
How TraceLink Supports SOM ESM Aggregation
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, enables secure, compliant aggregation event reporting by:
- Triggering aggregation directly from ESM workflows.
- Capturing EPCIS 1.2-compliant aggregation events in real time.
- Transmitting aggregation data to internal systems and external partners.
- Providing dashboards and audit trails to monitor aggregation activity, status, and compliance outcomes.
- Ensuring data integrity and non-repudiation through optional digital signatures and secure exchange protocols.
Explore More Serialization & Compliance Capabilities
- SOM ESM Sales Shipment (EPCIS 1.2) – Record serialized shipments.
- SOM ESM Sales Shipment (TL XML) – Record serialized shipments.
- SOM ESM Receipt (EPCIS 1.2) – Confirm serialized product receipt.
- SOM ESM Receipt (TL XML) – Confirm serialized product receipt.
- SOM ESM Decommission (EPCIS 1.2) – Deactivate flagged serialized units.
Need Help Implementing EPCIS 1.2?
Contact Us to learn how our OPUS Platform and B2N Integrate-Once™ model can help you automate serialized aggregation, improve accurate inventory visibility, and ensure traceability across your life sciences and healthcare supply chain.
