Serialization will be a global requirement by early 2019, but a lack of global standards brings great complexity.
In the adoption of global regulations to protect patient safety and product integrity, serialization is common across most adopted regulations, and will soon impact the majority of the global drug supply. However, regulations differ from country to country: serial number formats vary widely from GS1 global standards to unique versions; packaging hierarchies range from solely unit level application to multi-tier relationships requiring aggregation; and uniqueness and randomization principles also vary.
Because of this lack of global standards, companies face unprecedented complexity, cost, and risk in how they implement strategies in different parts of the world. The key is to expect diversity and plan for it with a solution that can accommodate every variation.
Choose a truly global serialization platform with the flexibility you need.
TraceLink's comprehensive serialization solutions simplify your ability to meet the requirements of the evolving global regulatory and trade ecosystem, providing a single flexible platform whether you are serving patients in the United States, targeting EU expansion or preparing to enter the South Korea, Brazil, or Russia markets.
- Create reusable serial number generation profiles for all product types, logistical units (item, case, bundle, pallet) and market destinations.
- Support global standard and country-specific formats to create GS1 standard formats (SGTIN, SSCC), generate custom formats for places like Brazil and import custom formats and lists from China.
- Manage and monitor allocations automatically for all packaging codes by defining serial number creation rules for request limits, minimum thresholds, uniqueness checks, randomization requirements and more.
- Establish a common interface to capture and respond to provisioning requests from internal packaging sites and external CMO/CPO partners using dozens of diverse line management systems.
- Manage serialized inventory operations such as product movement capture or pharmaceutical product aggregation changes across plant and warehouse operations whether they are internal locations or executed at CMO or 3PL partner locations.
Trigger compliance activities resulting from serialized product events to meet traceability data exchange or government reporting requirements.