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Global Compliance

United States

Manage US DSCSA requirements for both lot level and serialized item traceability. TraceLink’s Integrate Once, Interoperate with Everyone™ architecture enables rapid onboarding and integration with suppliers for the receipt and shipping of US DSCSA transactions. Support for dispenser specific use cases includes loan/borrow and 340B programs. End-to-end administration service works to manage exceptions, users, and master data as well as support the paper to digital transaction conversion process for lot level traceability.

Benefits

  • Lot and item level tracking. Manage transaction histories, information, and statements for both serialized and non-serialized items.

  • Rapid trade partner onboarding. Use a network model to eliminate the need for point to point connections with suppliers.

  • Broad set of supported use cases. Support for unique dispenser use cases such as drop shipments, loan/borrow, and 340B programs.

  • Limited resource investment. Fully outsourced administration services for managing exceptions, product master data, and the paper to digital conversion process.

Applications

Product Track
Product Track provides wholesalers with the functionality to receive and manage transaction information, histories, and statements in compliance with the Drug Supply Chain Security Act (DSCSA). Product Track verifies the inbound EDI 856 ASN for lot level and the EPCIS message for serialized product to ensure they include all of the required elements for compliance. Transactions are stored where they are searchable or readily available for inclusion in messages sent to downstream customers.

End-to-End Administration
End-to-End Administration services provide dispensers with an option to fully outsource the administration of the Product Track solution. Administration may include adding and removing suppliers, products, and users. Exceptions are managed on behalf of the dispenser through Product Track experts with deep pharmacy operations domain experience. Service also provides a conversion process to digitize any paper-based DSCSA compliance documents that have been received from suppliers.

Edge Track
Edge Track provides hospitals and pharmacies that have centralized distribution with the functionality to manage serialization throughout warehouse processes. Whether receiving serialized or non-serialized product, Edge Track facilitates the data capture through mobile devices and communicates to the appropriate business systems — ERP, WMS, and serialization repository.

Pharmacy Application
TraceLink’s Pharmacy Application provides hospitals and pharmacies with comprehensive tablet and smartphone-based applications to interact with serialized medicines for regulatory compliance and value-based business benefit. As serialized product volumes continue to rapidly increase across the globe, the ability of pharmacists and dispensing doctors to verify the authenticity of unique medicines, gain real-time access to product master data and notifications, and engage with interactive medicine content within their existing dispensing process becomes possible for the first time.

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