Currently, there are over 40 countries that have either final legislation, legislation in process, or plans to introduce legislation regarding serialization, traceability, and reporting on medicine distribution. Although each market has similarities in its regulatory requirements, the reality is the requirements for each market are unique. Achieving and maintaining compliance requires integration across internal manufacturing and distribution systems and processes, and integration to partner systems and processes, including contract manufacturers, third-party logistics providers, and customers. It is not unusual for a single company to have integrations with 100s of trade partners to meet their compliance requirements. Addressing each market requirement individually has proven unsustainable as one-off approaches are expensive and introduce unnecessary risks to supplying medicines to patients.

TraceLink Global Serialization, Traceability, and Global Platform provide a single platform by which life science companies can meet their global serialization, traceability, and government reporting requirements. Developed and hosted on the Opus Digital Network Platform, the TraceLink solution provides:

• Network: A network of over 280k life science entities that have been onboarded and integrated. These entities can be discovered and linked to the exchange of serialization and traceability information.
• Scalability: High volume transaction processing of billions of serial numbers and events associated with medicine distribution. An active-active deployment model ensures that serialization, traceability, and compliance does not impact the operational efficiency required in medicine manufacturing and distribution.
• Compliance: Individual market and country applications that meet specific country requirements for report generation, data mapping and central system connectivity. A network-tenant solution ensures that new functionality can be rapidly deployed while maintaining backward compatibility with existing partner integrations.
• Ensuring Supply: A unique network-wide data model digitally representing the flow of medicines into and throughout a market or country. This data model can drive collective intelligence solutions to address critical industry issues such as more advanced predictions of pending drug shortages.