Expand Your Pedigree

Evolving and sweeping regulatory requirements are forcing pharmaceutical supply chain participants to reinvent their business processes. This comes at a time when increased business complexity and diminishing supply chain efficiencies threaten profit margins across all segments of the industry.

As a consequence, pharmaceutical supply chain partners are pursuing value chain synergies where mutual business objectives present a win-win opportunity. Ensuring compliance across trading partners In order to comply with new regulatory requirements, drug manufacturers are in the midst of planning and executing serialization and electronic pedigree (e-pedigree) capabilities for their production and packaging lines— projects affecting hundreds to thousands of product SKU’s.

While much of the work has focused on the design, deployment, integration and testing of serialization and pedigree technologies within a company, it’s also crucial to focus on aligning, or “on-ramping,” the value chain of upstream and downstream trade partners. There are significant challenges to aligning trade partner systems, processes and information exchange requirements. On-ramping a supply chain network requires extensive collaboration with trade partners and consumes significant time and resources.

Underestimating the need for on-ramping the value chain, however, will introduce risk to schedules and budgets, and even operations and compliance efforts. However, when done properly, on-ramping will help manufacturers enable a variety of value-added business benefits.

Trade Partner On-Ramping Considerations

Trade partner requirements will need to be analyzed, and interoperability testing planned and executed with each trading partner. Key considerations when planning for trade partner on-ramping include:

• How many and what type of trade partners does your company have?
• What specific inter-company business processes, such as pedigree and serialization, does your company share with each trading partner?
• Do you have common alignment on roles, responsibilities, and legal liabilities across identified shared business processes?
• What is the IT infrastructure readiness of trade partners?
• Have you determined how information will be transmitted and received from each trading partner (e.g., EPC events, AS2, FTP, Web Services)?
• Is there agreement as to what will be used for each data element in the pedigree?
• Has a decision been made on what data will be sent and when (e.g., serialization information, serialized product pedigree, serialized ASN, some mix of the above)?
• Are there plans for transitioning from non-serialized to serialized products?
• Has a testing approach and schedule been developed?
• How will serialization interoperability issues be resolved?
• How will trading partner profiles in internal IT systems be set up and maintained?

What makes enabling a value chain network a daunting task is the necessity to perform the above tasks with every supply chain trading partner. The time and resources required to overcome track and trace and pedigree interoperability challenges can be technically difficult among a wide range of point solutions. And these tasks become even more burdensome as the number, complexity and sophistication of trade partners increases.

Experiences From the Field

Experiences from industry pilots have shown that trading partner interoperability data alignment, interface design and testing activities can have an impact on a company’s implementation schedule equal to that of product serialization and pedigree systems’ projects. Some trade partners, such as smaller partners and end dispensation points, lack the technical solutions required for compliance and will require support.

This will likely be in the form of a portal that can provide pedigree processing capabilities, including receipt, shipment, returns and certifications, as well as search tools. Industry experience has shown that developing reliable, repeatable and secure on-ramping methodologies that bring trade partners together within a business network can yield significant efficiencies.

These include dramatic reductions in time and resources required to integrate partners, lower costs and the establishment of a common communications foundation for all participants. Uncovering business value from serialization and pedigree data Business value will be driven by the ability to leverage serialization and pedigree data moving through an organization and across a trade partner network.

This information can be used to execute collaborative business processes and turned into actionable intelligence that leads to increased supply chain visibility and control, greater operational efficiencies and improved decision making and business agility. Manufacturers need to stop viewing serialization and pedigree projects as functional point solutions that are yet another cost-of-doing business expense. Companies that take a comprehensive and integrated approach to serialization, e-pedigree and trade partner collaboration will be able to execute their compliance projects as strategic business enablers. They can realize a wealth of business value and a solid return on what were originally considered simply compliance investments.