Pharmaceutical Serialization and Track-and-Trace Solutions
Product serialization, DSCSA, EU FMD compliance
Pharmaceutical serialization and track-and-trace systems assign unique identifiers to individual drug packages and track them through the supply chain. These systems are mandated by regulations like the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD) to combat counterfeit drugs and enable rapid recall capabilities.
Key Certifications
Core Features
What is Serialization & Track-and-Trace?
Serialization software manages the generation, printing, verification, and reporting of unique serial numbers on pharmaceutical packaging. Track-and-trace systems capture product movement throughout the distribution chain, from manufacturer to dispenser, creating an auditable pedigree for each package and enabling unit-level traceability.
Key Features to Consider
- Serial number generation and management
- Level 2-5 packaging line integration
- Aggregation (case and pallet hierarchy)
- Label printing and vision system verification
- EPCIS event capture and reporting
- Master data management for products and locations
- Repository systems for serialization data
- Chargeback and returns processing
- Regulatory reporting (DSCSA, EU FMD)
- Integration with ERP and manufacturing systems
Compliance Requirements
Serialization systems must comply with DSCSA requirements in the US (including unit-level traceability), EU FMD (product identifier on secondary packaging), and similar regulations globally. Systems must maintain transaction history, transaction information, and transaction statements. Data retention requirements often span years or the product shelf life plus one year.
Common Use Cases
- Implementing DSCSA-compliant serialization for US pharmaceutical distribution
- Managing EU FMD compliance with national verification systems
- Coordinating serialization across contract manufacturing organizations (CMOs)
- Processing saleable returns with verification
- Enabling targeted recalls at the lot or serial number level
- Tracking clinical trial materials with unique identifiers
Ready to Find Your Solution?
Browse our directory of pharmaceutical serialization & track-and-trace vendors. Compare features, pricing, and real user reviews to make an informed decision.