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A new digital supply network developed by TraceLink promises to improve collaboration and visibility in the pharmaceutical manufacturing industry supply chain.
The cloud-based TraceLink Network allows pharmaceutical companies and their business partners, suppliers and customers to collaborate and exchange data. This helps pharmaceutical manufacturers deal with regulations, including the U.S. FDA's Drug Supply Chain Security Act (DSCSA) that requires all drugs to have a unique product identifier to promote visibility in the supply chain and counteract counterfeit or compromised drugs, according to John Bermudez, TraceLink general manager of Digital Network Platform [DNP].
TraceLink, based in North Reading, Mass., has its origins in developing track-and-trace applications for the pharmaceutical industry.
When a company joins the TraceLink Network, all of its trading partners can be onboarded, a concept Bermudez calls "integrate once, interoperate everywhere." This has made it possible to grow the network very quickly. The TraceLink Network currently has more than 1,100 customers that have onboarded more than 275,000 partners, Bermudez said.
"One of the challenges of building a network is onboarding companies, so if you have to spend months and lots of dollars onboarding a company, it's just not possible to grow a network to 300,000 entities very quickly," he said.
Supply chain visibility critical in pharma
The TraceLink Network allows member companies to have a serial number generated on the network that stays with the product throughout the supply chain, from the manufacturer to the consumer. This is important in a supply chain that involves large drug manufacturers, contract manufacturers, large and small wholesalers, hospitals and retail pharmacies, Bermudez explained.
The issue is also global as the European Union and countries around the world have implemented similar requirements.
"By building this network, eventually we will know where every single individual pharmaceutical product is in the world," Bermudez said. "We have this baseline, which we call the life sciences cloud, that describes the whole pharmaceutical industry."
Digital supply networks supplant traditional supply chains
The TraceLink Network is not an entirely new concept, but is an example of digital supply networks [DSNs] that are becoming more common in manufacturing. DSNs take advantage of data that can be acquired inexpensively, as well as greater computing power and connectivity to supplant traditional supply chains, according to a Deloitte report, "The rise of the digital supply network."
Traditional supply chains rely on a linear movement of information with a structured sequence of events from development, planning, sourcing, manufacturing, delivery and support. However, participants in the chain have little visibility into the processes, leading to inefficiencies and making it difficult to adjust to changes. A DSN centers information and collaboration among the stakeholders around a digital core, with multidirectional connections and more visibility into processes.
Along these lines, TraceLink has also introduced the DNP, which allows companies to create applications that enhance the value of the Digital Network, Bermudez explained. The Digital Network and the DNP allow digital supply chain applications to be built quicker, he said.
"For example, you can build a network model of your supply chain, which will live in the DNP, and then be able to execute various business processes over that -- whether it's tracking a shipment, understanding how much inventory is at any node in the supply chain, understanding any trouble spots where product is not getting to or there's too much product," Bermudez said.
The network is better than point-to-point collaboration
The TraceLink Digital Network makes it much easier to collaborate with partners and contract manufacturers, according to Frank Binder, head of global supply chain management at Santen, a pharmaceutical manufacturer based in Osaka, Japan.
Santen, which manufactures products for eye conditions, joined the TraceLink Digital Network earlier this year to help it comply with new or impending regulations in the U.S., the European Union, and other countries.
These new regulations mean that drug manufacturers will need to generate and manage unique identifiers for every product they make, and most large manufacturers rely on various contract manufacturers, which increase the complexity.
"This unique identifier has to be then shared with the national databases in all the countries where this is required," Binder said.
"Initially, when these regulations came up, I thought that I would have to build interfaces with all my contract manufacturers, and they have to build and manage interfaces with all the national databases, which, of course, would be a very complex task," Binder said.
The ability to share that information via TraceLink's cloud-based network reduces the complexity of supply chain compliance regulations, Binder explained.
The Digital Network Platform adds value to the network
Getting on the network was valuable, but Binder said the new DNP has the potential to add much more value.
The handling of serial numbers helps Santen comply with regulations and reduce the risk of counterfeits, according to Binder, but the DNP will allow different types of exchanges between companies on the network.
"We can think of planning or exchanging data on the execution of production, and have much more transparency for what's actually happening in real time," Binder said. "The planning and information-sharing between supply chain partners is for us the area that we are most keen on exploring in the platform."
Enhancing, not replacing ERP
The TraceLink DNP can help companies transcend the limitations of traditional ERP systems, which are often difficult to integrate, according to Roddy Martin, TraceLink's chief digital strategist.
"The DNP enables and codifies connectivity, collaboration on data sharing, and visibility, but it doesn't replace the ERP systems," Martin said. "If you're a pharmaceutical manufacturer, you can connect to a retail pharmacy on the platform, but your ERP system data is being fed into the platform and is fundamentally the fuel that drives the platform."
However, TraceLink Digital Network partners may start to develop applications that perform some ERP functions, Martin explained.
"Over time, partners could start building applications on the DNP that do planning and visibility or inventory optimization," he said. "So there may be a migration of functionality that today exists in your ERP or supply chain system. It becomes a scale issue, as the platform becomes more and more capable, and as more partners join the network, the more powerful the network becomes."