Table of contents
Background
In the fast-paced world of pharmaceutical supply chains, ensuring compliance with the Drug Supply Chain Security Act (DSCSA) is critical. For Techdow, a high-performance pharmaceutical company that is committed to quality and reliability for patients and customers, navigating these compliance requirements was daunting. The stakes were high, as the organization sells critical FDA-approved products for use in hospital and clinical settings, non-compliance would pose significant potential risks to their operations and reputation.
The Challenge
In 2023, Techdow proactively took steps to ensure its DSCSA compliance by partnering with a third-party vendor to manage the complex process of facilitating connections and data integration with its third-party logistics providers (3PLs). Confident in the vendor’s assurances that progress was on track, Techdow diligently monitored the situation, believing everything was moving forward smoothly.
By June 2024, a major U.S. customer raised concerns about compliance, warning that they could not continue doing business with companies that were not fully compliant with DSCSA requirements. Upon investigation, Techdow demonstrated strong leadership and accountability, uncovering that while initial progress had been made by the vendor, full connectivity with their 3PL had not yet been achieved. Furthermore, it was discovered that the vendor had been relying on TraceLink for certain data management tasks without fully implementing the necessary systems to ensure seamless, ongoing operations.
The Turning Point
Faced with the urgent need to resolve the compliance issue, Techdow turned to TraceLink for a swift and effective solution. The TraceLink team immediately recognized the critical nature of the situation and quickly mobilized to address the challenges. Their primary focus was to ensure that Techdow’s 3PL’s Level 4 system had the necessary connectivity to access critical data and maintain seamless operations with their top wholesalers.
Time was of the essence, and the situation required a highly coordinated response. Bilal Khan, CEO of Techdow notes, “We needed access data to flow by yesterday for our top wholesalers.” The TraceLink team activated quickly and worked closely with Techdow to meet their specific needs and technical requirements, rapidly developing and implementing a plan to establish the required links. Their expertise and fast action helped Techdow regain control of its compliance efforts.
Thanks to the rapid intervention and support from TraceLink, Techdow was able to avert a potentially disruptive situation and continue meeting its obligations without any setbacks.
Rapid Implementation
The implementation began by understanding Techdow's specific challenges, particularly the urgency of getting one of the Big 3 wholesalers live. Once this priority was established, the focus was on linking the Big 3 before working on the remaining setup. Within just two days, Techdow was linked and in production with the "Big 3" wholesalers. This rapid turnaround was possible due to the strength of the TraceLink network. Since the Big 3 are already linked, no additional work was required on their side once Techdow began sending data, significantly speeding up the time to production.
In the following five days, additional links were established, further solidifying Techdow’s compliance status. The process of onboarding new partners was streamlined, requiring only a few clicks to begin sending data to the newly linked partners. As a result, Techdow could engage with key partners smoothly and maintain strong business relationships. Operations have since continued without issues, and the compliance process, once filled with uncertainty, is now described as "very smooth," with ongoing support from the TraceLink team.
Customer Feedback
Techdow's leadership expressed deep gratitude for the support they received from TraceLink. Despite being a mid-sized manufacturer in the U.S. market, they felt they were treated as one of the most important clients. The consistent, high-quality service provided by TraceLink's team, regardless of the individual they interacted with, made Techdow feel valued and supported.
It doesn’t matter who we work with on the TraceLink team they have all been great. When you are a smaller organization you appreciate the service and attention and not being pushed to the back burner. We feel like one of the most important clients. TraceLink is running an amazing team that is committed to the success of its customers.
Bilal Khan, CEO of Techdow
Current customer scorecards reflect 100% EPCIS data performance in accordance with DSCSA.
Looking Forward
While the immediate crisis has been resolved, Techdow has identified several areas for further improvement. They see an opportunity to leverage additional TraceLink solutions, such as Process Orchestration for Empowered Teams (POET) for handling compliance exceptions and digital recalls, to enhance their overall operational efficiency.
We appreciate everything that TraceLink has done. Working with TraceLink, we have questions, and we feel that TraceLink has the answers. We can do more with this data to improve patient outcomes, so the future is bright.
Paul Cooper, Senior Director of Commercial Sales & Operations at Techdow
Ultimately, Techdow is grateful for TraceLink's prompt intervention, which not only preserved key business relationships but also strengthened their confidence in meeting DSCSA compliance. This experience has reaffirmed their trust in TraceLink as a dedicated partner, demonstrating that even companies of their size can benefit from world-class support and innovative solutions when it matters most.
