Global Traceability and Compliance

Reduce the cost and complexity of complying with chain-of-custody and track-and-trace regulations

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Stringent regulations for pharmaceuticals and medical devices (including U.S. DSCSA, Brazil Anvisa RDC-54, China SFDA DMF and U.S. FDAMA) require organizations to track product movement from the manufacturer to the pharmacy, and trace financial and physical chains of custody from the pharmacy back to the manufacturer. To ensure compliance in the coming months and years, pharmaceutical and medical device supply chain leaders must re-evaluate their current and future traceability strategies now.

Axway 5 Suite can help.

How does the solution work?

Relevant Axway 5 Suite Products

  • Axway Track & Trace

    Unit-level serialization, point-of-sale verification and central government reporting

    • Deploy on-premise or in the cloud to leverage your investment in existing traceability infrastructure
    • Establish a global EPCIS-certified solution
    • Implement one centralized regulatory reporting infrastructure
    • Manage one security framework with a streamlined user experience
    • Maintain regional autonomy with flexible distribution center integration
  • Success Story: Life Sciences

    Genzyme

    Meeting global compliance initiatives while streamlining serial number management capabilities across locations worldwide

  • Success Story: Life Sciences

    AstraZeneca

    Handling more than 100 million serialized product-data records across 3 global sites