Table of contents
Overview
The SOM ESM Take Product Sample transaction is an XML-based message used to document the internal removal of serialized pharmaceutical products from inventory for inspection, testing, or investigation. This transaction works in conjunction with Enterprise Serialization Management (ESM) systems and complies with GS1 EPCIS 1.2 standards.
This transaction ensures that product sampling actions are traceable, compliant, and securely recorded—supporting DSCSA, global track and trace, and internal SOPs for QA, regulatory, and controlled substance handling processes.
Key Use Cases
- Document the removal of serialized units for testing or investigation.
- Enable QA and compliance teams to trace sampled products throughout the lifecycle.
- Ensure DSCSA and global track and trace compliance through structured, standards-based event capture.
- Maintain an auditable record of product sampling decisions.
- Prevent unauthorized distribution or reuse of sampled inventory.
- Integrate with internal quality systems and serialization repositories.
Data Elements Included
- Event Type: ObjectEvent with business step “sampling” or “removal_for_testing”.
- Serialized Product Identifiers (EPCs): SGTINs for each sampled unit.
- Event Time and Time Zone: Timestamp of the sampling event.
- Read Point: Physical location of the sampling action (e.g., QA lab, warehouse).
- Business Location: GLN or internal site code where the sampling occurred.
- Disposition: Status of the sampled product (e.g., “under_investigation”, “quarantined”).
- Reason Code: Indicates why the sample was taken (e.g., “QA_REVIEW”).
- User or System Identifier (optional): Who initiated or approved the sampling.
- Digital Signature (optional): For regulatory-grade data integrity.
- Comments or Notes (optional): Free-text for QA or compliance documentation.
Benefits of SOM ESM Take Product Sample
- Ensures regulatory compliance with DSCSA, global track and trace and internal SOPs.
- Provides full traceability of sampled serialized units from removal to disposition.
- Supports secure, standards-based data exchange using EPCIS 1.2 XML.
- Improves quality assurance and investigation workflows by linking sampling to alerts and outcomes.
- Maintains a tamper-proof audit trail for regulatory inspections or internal reviews.
Business Process – SOM ESM Take Product Sample
The SOM ESM Take Product Sample transaction is a key part of TraceLink’s Serialized Operations Manager and compliance workflow. It typically occurs after:
- A sales order is flagged for unusual or high-risk patterns.
- An internal investigation is launched by QA or compliance teams.
- Specific serialized units are selected and removed from inventory for sampling or testing.
- SOM ESM Take Product Sample (EPCIS 1.2) is triggered to log the sampling event.
How TraceLink Supports SOM ESM Take Product Sample
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, provides a secure and compliant solution for serialized product sampling through:
- Triggering sampling events from within ESM workflows, linked to compliance alerts or QA actions.
- Capturing EPCIS 1.2-compliant sampling data with full serialization context.
- Distributing sampling events to internal systems or compliance teams in real time.
- Providing dashboards and audit logs to track sampling activity, reasons, and outcomes.
- Ensuring data security and integrity with optional digital signatures and secure transmission.
Explore More Serialization & Compliance Capabilities
- SOM ESM Receipt (EPCIS 1.2) – Confirm serialized product receipt.
- SOM ESM Receipt (TL XML) – Confirm serialized product receipt.
- SOM ESM Sales Shipment (EPCIS 1.2) – Record serialized shipments.
- SOM ESM Sales Shipment (TL XML) – Record serialized shipments.
- 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 product sampling, streamline product investigations, and ensure full compliance across your life sciences and healthcare supply chain.
