Manage Every Link in the Chain with Axway ePedigree

In Life Sciences industries, branded pharmaceutical, biotech, and specialty drug manufacturers are prime targets of counterfeiters. The World Health Organization (WHO) estimates that $75 billion in legitimate corporate sales are lost each year due to the sale of counterfeit drugs.

To improve the safety and integrity of the global supply chain, the United Stated Food & Drug Administration (FDA), individual U.S. states including California and Florida, the EU, and Turkey are planning to institute stringent pedigree regulations in the coming months. These anti-counterfeiting regulations will require pharmaceutical supply chain constituents to provide drug pedigrees, or custodial histories, which trace each drug’s chain of ownership from the pharmacy back to the manufacturer.

Axway Track & Trace and ePedigree are GS1 standards-based anti-counterfeiting solutions that centrally manage regulatory requirements to reduce the cost and complexity of compliance with pedigree laws.

Track & Trace manages serialized and non-serialized product events in an open framework to allow internal and external trusted parties to access product identification, location, pedigree, and event data at any point in the supply chain.

Fully integrated with Track & Trace, Axway ePedigree guarantees the authenticity of origin and demonstrates possession as pharmaceutical drugs move through the supply chain, delivering a clear trail of ownership at each step of the process.

ePedigree provides:

  • Complete visibility into the custodial history of drugs or drug lots
  • Comprehensive archiving, reporting, and alerting for regulatory compliance and exception management
  • Continuous alignment with evolving Electronic Product Code (EPC) and RFID standards
  • 21 CFR Part 11 compliance for electronic records and digital signatures

Track & Trace and ePedigree allow you to link physical inventory movements with B2B transactions, such as purchase orders, ship notices, and invoices. This linkage delivers greater business activity monitoring of your supply chain and helps you achieve sustainable business value from what might normally be considered a cost of compliance.

Most importantly, all members of the supply chain can leverage existing investments in supply chain automation, serialization, and enterprise systems to improve the speed and quality of shipping and receiving, expedite returns processing, and sharpen recall precision.

Manufacturers can use ePedigree to:

  • Create and send electronic pedigrees
  • Store and access electronic pedigrees
  • Validate electronic pedigrees for returns processing

Wholesalers can use ePedigree to:

  • Validate electronic pedigrees
  • Correlate electronic pedigrees to physical inventory
  • Create and send electronic pedigrees as inventory is split
  • Store and access electronic pedigrees

Retailers can use ePedigree to:

  • Validate electronic pedigrees prior to dispensing drugs
  • Correlate electronic pedigrees to physical inventory
  • Create and send electronic pedigrees for returns processing
  • Store and access electronic pedigrees
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