Axway to Bolster Patient Safety and Compliance for AstraZeneca

Track & Trace Solution Helps Prevent Counterfeiting of Medicines and Ensures Security, Flexibility and Scalability
PHOENIX, 2 December 2010 - Axway today announced that AstraZeneca, a global biopharmaceutical company that develops, manufactures and markets prescription medicines, is using its Track & Trace solution to enhance patient safety and protect brand integrity through serialization of medicine packs, as part of a comprehensive product security strategy.

AstraZeneca has taken a multi-faceted approach to combating counterfeiting and ultimately improve patient safety. Implementing standardized item level serialization - in combination with tamper evident packaging - was identified early on as a powerful approach to respond to these challenges. Axway's Track & Trace solution was chosen as the unique product number repository to achieve these goals.

Using the solution from Axway, the Business Interaction Networks company, AstraZeneca has increased product safety by securely collecting product security data for every pack of medicine of an increasing number of its brands in a global repository, which can be verified against packs within the supply chain. The Axway Track & Trace repository is now handling close to 100 million serialized product data records, from the three global sites where item-level serialization was first implemented. By the end of 2010, ten sites and a total of 33 production lines will be feeding serial numbers into the system, with further sites and lines planned to be connected in 2011.

"We needed a solution that would be flexible and adaptable to fit with our approach. At the time, there was nothing on the market that met our requirements, but Axway had modules that provided a solid foundation for the solution AstraZeneca wanted to build. It really was a co-development project," said Christoph Krähenbühl, IS program manager, pack coding and product security at AstraZeneca Global Operations Information.

Security and stability are very important to AstraZeneca, especially in view of the fact that large volumes of codes are continually added. Axway Track & Trace is now a central component of AstraZeneca's global systems-based product security approach, and is used as an object-event repository of unique serial numbers.

"The global growth of reimbursement fraud and counterfeit medicines has resulted in patient safety risks for both governments and pharmaceutical companies," said Dave Bennett, chief technology officer, Axway. "In response, some territories have imposed regulations requiring pharmaceutical manufacturers to actively counter reimbursement fraud and counterfeiting through careful control of their business interactions. The reporting to comply with these regulations is managed directly from Axway's Track & Trace solution. AstraZeneca chose to pursue its product security item-level serialization and verification project as an internal initiative before there were market requirements to do so. This forward-thinking strategy has put the company in a position to respond quickly to emerging market requirements using Axway's flexible and scalable solution."

By enabling product traceability with Axway Track & Trace, AstraZeneca is achieving best practice in tackling counterfeiting and diversion, while complying with new regulations.

"As Axway's solution has evolved, the new version enables us to benefit from moving to the GS1 standards-based system EPC Information Services (EPCIS) that reduces the cost and complexity of complying with regulations. As part of our global programme, we have staff who are dedicated to monitoring all of these requirements, whether they are legal, regulatory or supply chain driven. Even though we have recently seen a surge of such requirements, we have not yet met a requirement that our adaptable, standards-based solution, built on Axway Track & Trace, cannot handle," Krähenbühl concluded.

About Track & Trace
Axway Track & Trace provides end-to-end transparency, supply chain logistics management and product authentication services across even the most complex supply chains. As a GS1-certified implementation of the EPCIS open standard, Track & Trace:

  • Securely captures, retrieves, transfers and manages key product and serialized event data. The event repository supports EPCIS queries to retrieve commissioning, packaging and product movement events. In addition, it captures change-of-ownership and other financial events to provide a complete picture of the product lifecycle.
  • Centrally manages serial number generation and allocation.
  • Easily integrates with third-party systems, including SAP's EPCIS system, allowing internal and external trusted parties to access product identification, location, and event data at any point in the supply chain.
  • Fully supports global trade identification numbers (GTIN) and global location numbers (GLN) for product and location identification.
  • Manages global compliance regulations for numerous countries, including emerging mandates in Turkey, Brazil, Israel and the United States.

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About Axway
Axway is the Business Interaction Networks company - the only provider in the market today to manage, run, secure, and monitor all of your business interactions, including email, files, messaging, services, events, and processes. Serving over 11,000 organizations in more than 100 countries, Axway facilitates the multi-enterprise transactions, processes and integration that accelerate business by eliminating the barriers between vendors, customers, departments, partners and suppliers. Axway's comprehensive offerings include business-to-business integration, managed file transfer, secure email, business activity monitoring, enterprise application integration, service-oriented architecture, business process management, track & trace and identity validation solutions. Axway provides professional and managed services, as well as cloud computing and Software-as-a-Service (SaaS) offerings. Headquartered in Phoenix, Arizona, Axway's global presence spans 20 countries.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines.  As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.

We work within AstraZeneca and with other pharmaceutical companies, governments, law enforcement agencies and healthcare professionals to prevent and detect counterfeiting.  Tackling counterfeiting is an important part of our commitment to patient safety. It also helps us to protect our reputation and maintain public confidence in healthcare systems.

Our approach includes:

  • Improving security to prevent counterfeit products from entering the supply chain
  • Making it easier to identify counterfeit products
  • Raising awareness among law enforcement agencies and other stakeholders
  • Investigating suspected cases and seeking prosecution of counterfeiters
  • Lobbying for stronger anti-counterfeiting regulations and penalties

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