Table of contents
Overview
The EPCIS 1.2 – SOM ESM Update Lot Information transaction is an XML-based message used to update or correct lot-level information for serialized pharmaceutical products and ensures that accurate lot data is available for downstream traceability, verification, and regulatory reporting.
With TraceLink’s OPUS Platform and B2N Integrate-Once™ architecture, this transaction works in conjunction with Enterprise Serialization Management (ESM) systems and enables secure, standards-based updates to EPCIS 1.2-compliant serialization records, ensuring that all trading partners and systems reference the most current and accurate lot information.
Key Use Cases
- Correct or update lot-level attributes (e.g., expiration date, GTIN, or batch number) for serialized products.
- Ensure accurate lot data is available for risk evaluation and product release.
- Maintain regulatory compliance by updating DSCSA and global track and trace product information.
- Synchronize serialization data across internal systems and external trading partners.
- Support downstream verification, traceability, and product recall readiness.
- Enable real-time updates without reissuing full EPCIS event history.
Data Elements Included
An EPCIS 1.2 – SOM ESM Update Lot Information transaction includes:
- Transaction Type: SOM ESM Update Lot Information.
- Lot Number: Unique identifier for the batch or lot being updated.
- Updated Attributes: GTIN, expiration date, manufacturing date, or other product metadata.
- Associated EPCs: Serialized product identifiers (SGTINs) linked to the lot.
- Business Location: Facility or region where the update originates.
- Timestamp: Date and time the update was submitted.
- Reason Code or Comments: Explanation for the update (e.g., correction, regulatory requirement).
- Digital Signature (optional): For secure, auditable confirmation.
- Sender/Receiver Identifiers: GLNs or partner codes for traceability.
Benefits of EPCIS 1.2 – SOM ESM Update Lot Information
- Ensures data accuracy across serialization, and regulatory systems.
- Enables real-time updates to lot-level information without reprocessing full shipments.
- Supports DSCSA and global track and trace compliance by maintaining accurate product metadata.
- Improves inventory and shipment decision-making with the most up-to-date lot attributes.
- Enhances traceability and verification by aligning EPCIS records with current lot data.
How TraceLink Supports EPCIS 1.2 SOM ESM Update Lot Information
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, enables secure, compliant, and efficient lot data updates by:
- Centralizes lot data updates by integrating with master data, serialization, and compliance systems.
- Synchronizes updated lot attributes (e.g., GTIN, expiration date, batch number) across all connected partners and internal platforms.
- Validates lot-level changes before applying updates to ensure data integrity and regulatory compliance.
- Distributes real-time updates to downstream systems without requiring reprocessing of full EPCIS event files.
- Maintains a full audit trail of all lot modifications for traceability, compliance, and quality control.
- Supports global partner alignment by ensuring consistent lot data across all serialization workflows.
Explore More Serialization & Compliance Capabilities
- EPCIS Serialization: Record and share commissioning events at unit, case, or pallet level for regulatory compliance.
- SOM End of Batch: Close a serialized batch and validate lot data before downstream use.
- DSCSA ASN: Share serialized shipment data with downstream partners.
- SOM Product Release: Authorize serialized units for shipment, requiring validated lot details.
- SOM Receipt: Confirm receipt of serialized shipments.
Need Help Implementing EPCIS 1.2?
Contact us to learn how our OPUS Platform and B2N Integrate-Once™ model can help you maintain accurate lot-level data, ensure SOM and DSCSA compliance, and enable real-time traceability across your pharmaceutical supply chain.
