Table of contents
Overview
The SOM Take Product Sample transaction is an XML-based message used to record the removal of serialized pharmaceutical products from inventory or shipment for sampling purposes. This transaction captures the event where a serialized unit is removed from inventory or a shipment for further inspection, testing, or investigation.
This transaction follows TraceLink XML standards and provides a structured, digital record of sampling activity, helping organizations maintain serialization integrity, prevent unauthorized product movement, and support quality and compliance workflows.
Key Use Cases
- Record the removal of serialized units for SOM or QA sampling.
- Ensure sampled products are accurately tracked and quarantined.
- Maintain compliance with DSCSA, DEA, and internal quality procedures.
- Provide traceability for units removed from shipments or inventory.
- Support downstream processes such as testing, investigation, or destruction.
- Integrate with QA, ERP, and serialization systems.
Data Elements Included
A TL XML – SOM Take Product Sample transaction includes:
- Transaction Type: SOMTakeProductSample
- Serialized Product Identifiers (EPCs): SGTINs or SSCCs of the units being sampled.
- Sampling Timestamp: Date and time when the sampling occurred.
- Read Point: Location where the sampling was performed (e.g., QA lab, warehouse).
- Business Location: GLN or internal identifier of the facility conducting the sample.
- Disposition: Typically "in_sampling", "quarantined", or "under_investigation".
- Sampling Reason Code (optional): Code indicating the rationale for sampling (e.g., “RANDOM_QA_CHECK”).
- Related Shipment or Batch ID (optional): Reference to the shipment or batch from which the sample was taken.
- Transaction ID (optional): Unique identifier for the sampling event.
- Digital Signature (optional): Ensures data integrity and non-repudiation.
- Comments or Notes (optional): Free-text field for QA notes, observations, or corrective actions.
Benefits of TL XML – SOM Take Product Sample
- Enables traceable, compliant removal of serialized products for sampling.
- Prevents unauthorized distribution of sampled units.
- Supports quality assurance and logistical workflows.
- Maintains serialization and inventory integrity.
- Provides audit-ready documentation for internal and regulatory inspections.
Business Process: TL XML – SOM Take Product Sample
The SOM Take Product Sample transaction supports:
- Quality, Risk, and Recall Management: Records serialized units removed for QA, enabling traceable sampling and proactive risk control.
- Inventory Management: Updates inventory to reflect removal/quarantine of sampled products.
- Product Serialization & Traceability: Maintains chain-of-custody records for each sampled serialized unit.
- Track and Trace & Government Compliance: Ensures compliance with DSCSA, DEA, and global sampling regulations.
- Returns and Reverse Logistics: Supports eligibility tracking for return, rework, or destruction of sampled units.
How TraceLink Supports TL XML – SOM Take Product Sample
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, enables secure and compliant product sampling workflows by:
- Capturing serialized sampling events from QA systems.
- Generating TL XML-compliant messages to document sampled units.
- Integrating with ERP, QA, and compliance systems for downstream processing.
- Logging all sampling events for traceability, audit readiness, and reporting.
- Supporting exception handling for flagged or non-conforming samples.
- Ensuring secure communication with optional digital signatures and encryption.
Explore More Serialization & Compliance Capabilities
- TL XML – SOM Product Release: Digitally authorize product movement after product release.
- TL XML – SOM ESM Sales Shipment: Record serialized shipments.
- TL XML – SOM ESM Receipt: Confirm serialized product receipt and verification.
- EPCIS 1.2 – SOM ESM Decommission: Deactivate serialized units flagged for removal.
Need Help Implementing TL XML Transactions?
Contact Us to learn how our OPUS Platform and B2N Integrate-Once™ model can help you automate product sampling workflows, ensure compliance, and maintain full traceability across your pharmaceutical supply chain.
