Serialization

Definition

Serialization is the process of assigning a unique identifier, often a barcode or data matrix code, to individual product units or packages, enabling track-and-trace capability throughout the supply chain. Serialization requirements, driven by regulations like the US Drug Supply Chain Security Act, are increasingly linked with EBR systems to tie serialized unit data back to specific batch records.

Benefits

Linking serialization data with the EBR strengthens end-to-end traceability, connecting a specific serialized unit not just to its batch number, but to the full underlying production record, supporting faster, more precise recalls and stronger supply chain security.

Use Case

A pharmaceutical packaging line assigns a unique serial number to each product carton. The EBR system links each serialized unit back to the originating batch record, so that if a counterfeit or diverted product is later identified in the supply chain, the manufacturer can trace it back to its exact production history.

Frequently Asked Questions (FAQ)

Related Terms

• Traceability
• Genealogy/Traceability