Table of contents
The past few years have put a spotlight on the importance of effective exception management. The ability to quickly identify and address issues can go a long way toward ensuring smooth operations. And, in the event of a catastrophic disruption, it also helps to speed your organization's response.
And now, for enterprises in the pharmaceutical and life sciences space, exception management is about to become even more important as the final phase of the U.S. Drug Supply Chain Security Act, which goes into effect on November 27, 2023, adds an interoperable data exchange step to the shipping process. This means pharma manufacturers and wholesale distributors can expect a sharp increase in exceptions due to missing data, product holds, packaging issues, and more.
In the past, exception management has often been reactive and ad hoc. But with the rapidly changing nature of global supply chains and new regulatory requirements, many enterprises in the space are beginning to rethink their approach, focusing on proactive and agile issue management. The goal is to avoid slow responses to exceptions that will negatively impact customer service.
The latest webinar in our DSCSA series, “Troubleshooting and Managing Exceptions Under DSCSA,” explored this topic in more detail. We discussed how to work with your customers in real time to resolve exceptions quickly—before they lead to disruptions, delays, and unhappy customers.
Here are the key takeaways:
- DSCSA 2023 will cause an uptick in exceptions. They can happen at any point in the supply chain, although they mainly surface with downstream partners. Sometimes, they result from problems with digital systems and serialization, but they can also arise from damaged packaging or smudged ink on labels. It’s also important to realize that these exceptions aren’t just a compliance risk—since products can’t be sold until they’re resolved, exceptions can disrupt the availability of lifesaving medications.
- There’s an opportunity here to dramatically improve the way you manage exceptions. A network-based approach is ideal for exception management because it connects all partners across the supply chain on a single purpose-built platform, making the whole process more scalable and efficient. A common network eliminates the need for configuring costly point-to-point connections to each trading partner and ensures continuous compliance with evolving requirements.
- TraceLink Supply Chain Work Management (now POET) takes advantage of its robust network of 270,000+ authenticated trading partners to streamline compliance exception management. With Supply Chain Work Management (now POET), you quickly create tasks to manage exceptions in a way that adheres to industry guidelines, both through the user interface or APIs with enterprise systems. It’s also immensely configurable, so you can add steps to suit your workflows, customize views and dashboards for different trading partners or business units, and more. It also keeps a record of the entire exception management process, so you can prove historical compliance and use your results to guide further process improvement.
Interested in learning more about DSCSA 2023 from a panel of subject matter experts and your industry peers? Sign up for the webinar series today—check out the track for manufacturers and distributors.
You can also watch the on-demand recording to learn more about the six different types of exceptions likely to spawn from DSCSA and how TraceLink helps you address them.
