Simple Trade Parnter Integration and Data Management for Repurposed Product
Repackagers play an important role in the U.S. pharmaceutical supply chain, buying product and transforming it into new entities for resale. In doing so, they perform both wholesale distribution and manufacturing functions and need to meet both segments' compliance requirements under DSCSA (the Drug Supply Chain Security Act).
If you’re a Repackager, the TraceLink network facilitates seamless connectivity to 650 pharmaceutical manufacturers—and it’s very likely that the drug suppliers selling medicines to you are already on the TraceLink network. When you begin receiving serialized product, you’ll be able to use TraceLink software to generate and manage new serial numbers for the products you repackage, as well as store the original information you’ve received from the manufacturer so that at any time you can identify the relationship between the parent shipment you received and the repurposed products you’ve sold downstream.
When it comes time to sell the product you’ve repackaged, you’ll be able to easily connect to 700 wholesale distributors and over 255,000 hospitals and pharmacies, greatly simplifying the management of serialized product data across your network of downstream business relationships.
Monitoring Regulatory Changes and Providing Validated Updates
One of the unique aspects of DSCSA is that the law phases in over a ten-year period from 2013 to 2023. While the law stipulates how drug movement must be regulated, it does not detail any best practices for “how” the industry should implement solutions that will address regulatory requirements. As industry associations and supply chain companies determine the best way to address the law’s requirements, standards groups like GS1 continue to refine their guidelines, while trade partners present new opportunities for refining aspects of their implementations. The reality is, your DSCSA compliance solution is not something you can just “set and forget”—it must also be agile and responsive so that I and when changes beyond your control occur, you’re able to update your solution and remain in compliance.
TraceLink’s unique network-tenant solution is purpose-built to help repackagers adapt to critical changes as soon as they take place. What’s more, automated validation testing reduces the burden of manual paper-driven validation processes and the need for in-house experts to manage them. TraceLink customers have access to the industry’s only automated validation solution, Automated Validation Manager, that offers:
- Automated test execution to eliminate the need for resources to manually write and execute validation scripts against new functionality.
- A full suite of automated tests continuously executed against each release and patches.
- Validation documents updated with each release to reflect new functionality, easily accessible through a web-based portal.
Get a Free Network Analysis
Healthcare providers and pharmacies typically find that 80-90% of their upstream pharmaceutical suppliers and wholesale distributors are already on the TraceLink Life Sciences Cloud. With just a single connection, you can connect to all of your supply chain partners and begin securely exchanging compliance data. This eliminates the time-consuming process of managing accurate compliance transactions internally, or paying costly fees to other track and trace providers that need to configure individual B2B connections to each of your supply chain partners.
TraceLink will perform a free network analysis for you. Before you start to work with us, you'll know exactly how many of your partners are already on the TraceLink network.