From Idea to Reality: Orchestrating End-to-End Exchange of EPCIS Information

Enterprises in the life sciences and pharmaceutical space have been looking towards 2023 for years as a pivotal moment for implementing the final traceability requirements of the U.S. Drug Supply Chain Security Act (DSCSA). Now, 2023 is here and reality is beginning to sink in. 

With the November 27 deadline less than 10 months away, it’s time for manufacturers, wholesalers, and dispensers alike to begin making their final preparations. Whether you’re well on the way or still getting off the ground, it’s likely you still have some questions. Perhaps you’ve even experienced some hiccups exchanging and verifying EPCIS data on the path toward compliance. 

Our recent webinar, “DSCSA 2023 Product Demonstration for EPCIS Exchange, Verification, and Exception Management,” offers a look at how this process can be executed in a timely, compliant manner. It covers a complete end-to-end use case, starting with a manufacturer shipping the product and ending with the dispenser receiving it and handling data exceptions, and also highlights how TraceLink simplifies the process at every step.

Part of what makes TraceLink such a valuable partner in the DSCSA compliance journey is that we offer a number of composable and flexible solutions that can be implemented in a way that best fits your unique requirements. The four solutions that support this case study include:

• Product Information Manager - Master Data Sharing: Enables companies to securely publish, retrieve, and share product, company, and partner master data across supply networks.
• Product Information Manager - Product Verification: Gives manufacturers, wholesale distributors, and other network entities the ability to verify serialized product identifiers and their status across supply network relationships.
• Serialized Operations Manager (SOM): Provides a serialization repository and operational hub for packaging, warehouse, and distribution activities to handle inbound/outbound product movements and status changes.
• Product Track: Delivers secure creation, management, and exchange of track and trace data for compliance with DSCSA, without requiring a specific configuration in SOM to meet the requirements for this region.

This case study also leverages Smart Inventory Tracker, which is an Android-based scanner natively integrated into TraceLink, and Supply Chain Work Management, which supplements the exchange and handling of EPCIS information with real-time, multienterprise collaboration capabilities for exception management and rapid resolution. 

Key takeaways for this webinar include:

• Sending EPCIS data downstream is a key element of DSCSA compliance requirements and the Product Track workflow makes it easy. All it takes is a few clicks to link you with your downstream trading partners so you can start sending EPCIS data to their Product Track portal. You can upload a CSV with some basic information on your trading partners and if they’re part of the network (which, with 270,000 authenticated members, they probably are), ServiceLinks will connect you. And if they aren’t, our network success team can onboard them for you so you don’t have to spend time chasing them down.
• Verification is a critical part of receiving and helps support suspect product investigation. Smart Inventory Tracker simplifies the process of checking compliance data as you’re receiving it, with an intuitive red light/green light confirmation. You can also check serial number status to see whether the serial number is in SOM, and quarantine products without compliance information. If there’s an issue, you can perform product identifier verification back to the manufacturer with TraceLink VRS, even if you’re a dispenser without a relationship to the manufacturer. 
• Exceptions are bound to happen, especially during the transition to serialized T2 data, so be prepared. When exceptions are uncovered, like in the verification process mentioned above, Supply Chain Work Management offers a streamlined tracking system for managing them. Normally, this process is handled by a combination of spreadsheets, emails, and meetings, which often results in delays as important tasks fall through the cracks. Since Supply Chain Work Management is integrated with the Opus network, it provides shared dashboards and customizable workflows for handling exceptions, all in one place.

Interested in learning more about DSCSA 2023 from a panel of subject matter experts and your industry peers? Sign up for our DSCSA webinar series today—there are tracks for both manufacturers and distributors or pharmacies and dispensers.

You can also watch the webinar for the complete demo, with a firsthand look at all the different systems in action.