Product Serialization

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Over 50 countries will be enforcing regulations to help control products as they pass through the pharmaceutical supply chain. While no two countries have passed the exact same requirements, they all rely on one core component: serialization. 

Only TraceLink, with more than 1339 active serialization customers and more than 20.5B serial numbers commissioned, can provide a unified global compliance view giving companies a “single source of truth” for their serialized inventory. With TraceLink, companies can create a serialized event repository and continuously monitor serialized operations to support compliance requirements and meet demands across global markets. A global approach to meeting compliance needs in each market means you are leveraging your investment in serialization to gain greater visibility into product movement, enabling a more reliable and safe drug supply and better service for patients.


  • Serial number generation. Manage serial number inventories by automatically replenishing serial number pools. 

  • Aggregation hierarchies. Capture and maintain parent-child relationships between packaging levels during the packaging process and post packaging re-work.

  • Serialization data access and verification. Control access to which packaging lines and CMOs product serial numbers can be allocated and verify serialization data received from the packaging line. 

  • Serial number reporting. Quickly identify serial number inventory and status by product as well as product and location. 

  • Trade partner integration. Easily configure connections with trade partners to send and receive serialized data exchanges, eliminating point-to-point integration risk. 

  • Serial number linking. Easily link original serial numbers to repackaged product serial numbers to meet regulatory requirements.

  • EPCIS support. Support for GS1 EPCIS interface and Core Business Vocabulary standards and implementation guidelines.

TraceLink’s Comprehensive Product Serialization Applications 

Serial Number Manager
Serial Number Manager provides serial number generation including randomization and sequential algorithms for different packaging levels. Serial number inventories are maintained by setting configurable parameters on when to generate more serial numbers. Configuration parameters are defined through serial number templates that are associated with each product. 

Serial Number Exchange
Serial Number Exchange manages the allocation of serial numbers from Serial Number Manager to the line management systems. Business logic works to verify serial number requests, commissioning, and aggregation information. Includes out of box integrations with leading line management systems, simplifying site onboarding and reducing risk. Connects to internal and external (CMO and CPO) sites to provide a single view into your serial number inventory and the product and site level. 

Serialized Operations Manager
Serialized Operations Manager manages the events associated with serialized product as it moves through supply chain and distribution processes. This design eliminates the need to embed serialization event management into the ERP and WMS systems as those systems are not designed to handle the scale at the operational performance required by supply chain and distribution processes. Serialized Operations Manager also provides pre-built business logic and workflow designed to monitor transaction flow and events in order to trigger actions in other applications such as TraceLink compliance and edge applications.

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