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.
Throughout the global supply chain, the top 20 pharmaceutical manufacturers, the major U.S. healthcare wholesalers and distributors, and leading U.S. retail drugstores rely on Axway 5 Suite to reduce the cost and complexity of compliance. In addition, the regulators themselves, including the U.S. FDA, have implemented Axway 5 Suite to help manage global traceability initiatives.
How does the solution work?
The winner of multiple iBusiness awards, Axway 5 Suite’s Track & Trace has evolved from a scalable EPCIS repository to a policy-driven enterprise solution rich with features created from real-world implementations and functional specifications.
Axway Track & Trace combines a SOA-based architecture with world-class integration technology to provide web services APIs for serial number management, packaging hierarchy and inference support, product ID verification, and certified EPCIS capture and query interfaces.
Track & Trace provides flexible architecture options ranging from a central global repository to a distributed network of regional repositories sharing data via EPCIS standards, and flexible deployment options, including hosted in the cloud and as a managed service.
Relevant Axway 5 Suite Products
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
Meeting global compliance initiatives while streamlining serial number management capabilities across locations worldwide
Handling more than 100 million serialized product-data records across 3 global sites
Join HDMA and other industry experts as they explore HDMA's ASN Exceptions Guidelines for the Drug Supply Chain Security Act, learn about data integration of DSCSA information and exchange data in technical scenarios.
This HDMA webinar, designed for the dispenser audience, provides an overview of the Drug Supply Chain Security Act (DSCSA), which paved the way for a single, federal framework to trace prescription medications through the supply chain.
5 steps to implementing successful traceability and interoperability for your pharma or medical device supply chain