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After identifying significant risks with its previous U.S. Drug Supply Chain Security Act (DSCSA) compliance software provider, Jazz Pharmaceuticals decided to switch to TraceLink. "TraceLink was by far the biggest player in the market with the most to offer," said Lorraine Guildea, Associate Director of Supply Chain at the global pharmaceutical manufacturing company, which is headquartered in Dublin, Ireland.
In this video, Guildea talks more about why Jazz Pharmaceuticals chose TraceLink and what the experience has been like preparing for the end of the DSCSA stabilization period. She also discusses her experience working with the TraceLink team and the business value of supply chain digitalization with TraceLink Multienterprise Information Network Tower (MINT). Watch the video to learn more.
Video Highlights:
00:11 - Can you provide some background on Jazz Pharmaceuticals?
00:24 - Why did Jazz Pharmaceuticals choose TraceLink?
00:57 - How will Jazz Pharmaceuticals address compliance exceptions after the DSCSA stabilization period ends?
02:01 - What has been your biggest DSCSA compliance challenge?
03:32 - How has TraceLink helped you prepare for the final phase of DSCSA?
03:54 - What value could TraceLink MINT bring to Jazz Pharmaceuticals?
TRANSCRIPT
TRANSCRIPT
My name is Lorraine Guildea and I'm the Associate Director of Supply Chain, specifically serialization, for Jazz Pharmaceuticals. Jazz Pharmaceuticals is a global organization headquartered in Ireland.
When I started with Jazz five years ago, we weren't partnered with TraceLink. At that time, we were with a different serialization partner, and I started as a serialization specialist.
We looked and risk assessed our vendor at that time and decided that there were some risks. So, we looked at the market and decided that TraceLink was the way forward. They were by far the biggest player in the market with the most to offer.
Jazz has a very good track record, though, in terms of our ability to transmit data. So, when we went live with the European solution and the FMD, we didn't have the hundreds and thousands of alerts that some organizations had. We had very few alerts relative to the serials we were sending, and that continues to this day. So, in my naivety, I thought that the U.S. DSCSA exceptions would follow a similar trend to the European falsified medicines alerts.
And that may indeed prove to be the case, but I think we as an organization have to prepare for a potential of a much greater number of exceptions than we have planned for. So, that's another reason why I'll discuss the TraceLink solutions in terms of exception management with the Jazz extended leadership team, just so that we are prepared for whatever happens. Once everything goes live with DSCSA.
The DSCSA preparation has been a roller coaster of activity and emotion. So, we have three 3PLs mainly. And our solution for the DSCSA is different with each of the 3PLs. With one, the EPCIS files are traveling from the 3PL through Jazz's instance of TraceLink and then downstream to the partners downstream. And then the third, it's a closed supply chain so the messages are traveling via Jazz to the end pharmacy.
TraceLink was instrumental in being able to establish those connections to look at what the use case was for each use case and help get the solution. You know, when you're dealing with the big three, they have their own definitions of what words mean.
They think they sent a sales order, that's not what they did. They did something completely different. And we were all speaking different languages for a long time. But I think where success finally happened was when we all got on calls together and hammered out what the definitions meant among each of the participants.
And when we did that, then those connections were made and we were able to successfully send messages downstream, which we have done now.
TraceLink was invaluable in mapping the processes and in identifying the key connections that need to be made and in ensuring that they happened. TraceLink supported when we had the wrong GLNs and helped us get the right GLNs and make those connections. So, they were invaluable to the success.
The value that MINT can give to the Jazz organization is that connection with our partners, our downstream and our upstream partners. In terms of the different messages we can send and receive, the different transaction types that will be processable and visible within that system.
If we can get all of our partners onto the platform and collaborate together on the platform, I think it will be invaluable to being able to see the end-to-end supply chain process going forward.
