EPCIS 1.2 – Serialization

Overview

The EPCIS 1.2 – Serialization transaction is an XML-based message used to capture and share commissioning (serialization) events for pharmaceutical products. It is compliant with the GS1 EPCIS 1.2 standard and includes detailed information about each serialized unit, including product identifiers, serial numbers, packaging hierarchy, and event metadata.

With TraceLink’s OPUS Platform and B2N Integrate-Once™ architecture, the EPCIS 1.2 Serialization message enables secure, interoperable exchange of serialized product data across global trading partners—supporting DSCSA, EU FMD, and other serialization mandates while improving end-to-end supply chain visibility.
 

Key Use Cases

• Report commissioning (serialization) events for unit, case, and pallet-level packaging.
• Share serialized product data with downstream trading partners, regulators, or contract manufacturers.
• Support compliance with US DSCSA, EU FMD, Russia, and other global serialization regulations.
• Enable traceability and verification at the individual unit level.
• Maintain digital chain-of-custody records for serialized products.
• Feed serialization data into downstream processes such as aggregation, shipping, and verification.
   

Data Elements Included

An EPCIS 1.2 – Serialization transaction includes:

• Event Type: Usually an ObjectEvent representing the commissioning of a product.
• EPCs (Electronic Product Codes): Serialized identifiers (SGTINs) for each unit.
• Event Time and Time Zone: When the serialization occurred.
• Read Point: Physical location where the event was captured (e.g., packaging line).
• Business Location: GLN of the facility performing serialization.
• Disposition: Status of the product (e.g., “active”).
• Business Step: “commissioning” to indicate serialization.
• Lot Number and Expiration Date (optional): For product traceability.
• Packaging Hierarchy (if applicable): Parent-child relationships for aggregation.
• Digital Signatures (optional): For data integrity and DSCSA compliance.
   

Benefits of EPCIS 1.2 – Serialization

• Ensures regulatory compliance with global serialization and traceability mandates.
• Provides secure, verifiable serialization event records for each unit.
• Enables downstream verification and traceability across the supply chain.
• Facilitates real-time data sharing with partners, regulators, and internal systems.
• Supports product recall management, diversion detection, and returns processing.
   

Business Process: EPCIS 1.2 – Serialization

• Serialization on Packaging Line: Unique serial numbers (SGTINs) are assigned and applied to units, cases, or pallets during packaging.
• Event Capture: Commissioning events are recorded as EPCIS 1.2 ObjectEvents, including product ID, serial number, timestamp, and location.
• Data Enrichment: Additional details like lot number, expiration date, and optional parent-child aggregation are added.
• Transmission to TraceLink: Serialized event data is securely sent to the TraceLink Opus Platform for validation and storage.
• Data Sharing: Serialized data is shared with authorized partners, regulatory bodies, or internal systems via B2N Integrate-Once™.
• Downstream Use: Commissioned data supports aggregation, shipping, verification, and compliance workflows.
   

How TraceLink Supports EPCIS 1.2 – Serialization

TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, delivers a secure and scalable EPCIS serialization solution by:

• Integrating with packaging lines, L4/L5 serialization systems, and ERP platforms to capture serialization events.
• Transmitting EPCIS 1.2-compliant serialization data to downstream partners and regulatory systems.
• Ensuring data integrity with optional digital signatures and secure transport protocols.
• Providing dashboards and audit trails for serialization status, compliance tracking, and event history.
• Enabling rapid onboarding of CMOs, 3PLs, and trading partners through a single connection.
   

Explore More Serialization & Compliance Capabilities

• Serialized Shipments: Record and communicate serialized product movement through outbound shipments.
• SOM Product Release: Confirm SOM evaluation results and authorize serialized products for shipment.
• HDA ASN: Comply with HDA guidelines for serialized shipping.
• SOM Receipt: Confirm serialized product receipt and reconcile with shipped items.

See All Serialization and EPCIS Capabilities  

Need Help Implementing EPCIS 1.2?

Contact us to learn how our Opus Platform and B2N Integrate-Once™ model can help you automate serialization data capture, ensure global compliance, and enable secure, interoperable data sharing across your digital supply network.