- Prepare to meet California, Brazil, and Turkey pedigree requirements and EPC Information Services (EPCIS) compliance requirements — all using the same solution
- Streamline serial number management capabilities across locations worldwide, while increasing supply chain visibility end-to-end
Compliant with Turkish track & trace requirements
No duplicate serial numbers, regardless of manufacture site location
Integrated operations and customer service systems to streamline operations
Secure access to product pedigree information
Customer service and analytics are able to analyze and prevent exceptions related to product serialization numbers
“We didn’t want to go with a company that had only one part of the solution. Axway had a future, and a suite of products that could get us all three things (ePedigree, track & trace, and event repository) that we were looking for.”
An Innovator in the World of Medicine
Genzyme, one of the world’s leading biotechnology companies, is dedicated to making a major positive impact on the lives of those afflicted with serious diseases. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, transplants, cancer, and diagnostic testing. Their commitment to innovation continues with research and development focused on these fields, in addition to immune disease, infectious disease, and other areas of unmet medical need.
Since 1981, the company has grown from a small start-up company in Boston to a diversified enterprise with more than 10,000 employees worldwide and 2007 revenues of $3.8 billion. In 2007, Genzyme was awarded the National Medal of Technology, the President of the United States’ highest honor for technological innovation.
Anti-Counterfeiting, Diversion and Global Regulatory Compliance
In early 2007, Genzyme performed a supply chain risk assessment. Based on the results, they decided to start the Serial Number Management System (SNMS) initiative to implement global serialization and track & trace. Shortly after this decision was made, California drug pedigree compliance became a top priority for many manufacturers and prompted the company to accelerate the initiative.
Similar to other leading manufacturers, the decision to serialize was not a response to regulatory mandates. Rather, it was a business-related response and direct reflection of Genzyme’s ongoing efforts to proactively safeguard patients from counterfeit drugs, prevent illegal diversion, and increase supply chain visibility.
In addition to selecting a system to manage their production line, Genzyme had three more technology selections to make:
- An ePedigree solution to meet California requirements
- An EPCglobal EPC Information Services (EPCIS)-compliant track & trace solution to manage serialized event data
- A serialized number management system to create and manage serial numbers, globally
Since Genzyme trades in both Europe and the U.S., it needed a solution that would not only enable EPCIS events but also meet California pedigree requirements. Axway’s Track & Trace, with its modular components, is being deployed to address Genzyme’s specific needs, providing a total solution for pedigree and track & trace. The solution can use document based ePedigree or EPCIS to exchange pedigree data. It captures pedigree events along with all other serialization, product movement, and distribution events and associates them to product master data.
In addition to meeting California pedigree requirements, Genzyme is also positioned to meet serialization requirements in Turkey and the EU directive for falsified medicines that is currently being defined by the member states. This was a key differentiator for Genzyme. “We didn’t want to go with a company that had only one part of the solution,” said Genzyme’s Peter Norton, serialization project manager. “Axway had a future, and a suite of products that could get us all three things (ePedigree, track & trace, and event repository) that we were looking for.”
Genzyme will utilize the Axway Track & Trace solution to integrate its operations and customer service systems to provide secure access to product pedigree information.
The Event Repository collects and manages data in a single place, to enable operational processes like aggregation and de-aggregation of items to cases, or cases to pallets. It also enables customer service and analytics to analyze and prevent abnormalities relating to product serialization numbers.
Also within the Track & Trace solution is a global serial number generation system that manages the generation of serial numbers globally. This prevents the generation of duplicate serial numbers, despite the fact that the same product may be manufactured in Genzyme’s facilities in Ireland and in the United States.