Although no two countries have the same compliance requirements, serialization has emerged as a common means of achieving global track and trace of medicines through the supply chain. Most laws incorporate some level of serialization, for example, in most situations the product at a unique level will be serialized. Some countries require verification, while others require that product movements be reported to the government as medicines move through the supply chain. The TraceLink Life Sciences Cloud delivers a range of modular SaaS applications and database architectures specifically designed to handle massive sets of serialized track and trace data, and network connectivity to trading partners in ways that on premise, single-tenant systems and relational databases cannot. Companies that subscribe to the Life Sciences Cloud network have access to a broad set of tools and applications that protect product integrity, ensure global track and trace compliance, improve external supply performance and cut operating costs.
By providing complete global connectivity and visibility across the pharmaceutical supply chain, the Life Sciences Cloud leverages cloud computing resources provided by Amazon Web Services (AWS), disseminating real-time data access, while ensuring data consistency for mission-critical operations.
TraceLink enables supply chain organizations to achieve compliance by integrating once to the Life Sciences Cloud and then linking directly to nearly 200,000 manufacturers, distributors and dispensers that are on the company’s network.
Our mission is to protect patients, enable health, ensure compliance for our customers, and eliminate counterfeiting from the global marketplace
Fostering strong partnerships, TraceLink is growing globally with offices in England, Europe, India, and Brazil. “We will be expanding our roots in Singapore and Japan in early 2016 as well,” informs Dahod. In order to drive more value in every aspect of the supply chain, TraceLink is also opening up its platform and extending its mobile solutions for a more effectual and collaborative supply chain ecosystem. “There’s an estimated $75 billion in counterfeit drugs sales in the market, and every year, anywhere from 200,000 to 1 million people die when counterfeit medicines prevent them from getting the critical health treatment they need. Our mission is to protect patients and enable health, and our sole focus is to transform the life sciences supply chain with the largest track and trace network that ensures compliance for our customers—and eliminates counterfeiting from the global marketplace,” ends Dahod.
TraceLink Announces Results from FDA DSCSA Pilot Program
TraceLink Inc., the leading digital platform company for the life science supply chain, today announced results from its pilot for the Food and Drug Administration (FDA) Pilot Project Program under the Drug Supply Chain Security Act (DSCSA).
The TraceLink pilot focused on two workstreams: digital recalls across a supply network; and an interoperable blockchain network solution. The pilots included 22 participating companies from pharmaceutical manufacturers, wholesale distributors, third party logistic providers, hospitals and retail pharmacies, including four of Gartners Healthcare Supply Chain Top 25 and a recognized supply chain leader in the Gartner Magic Quadrant for Third-Party Logistics Providers.
The pilot employed early stage technology solutions to address top pharmaceutical supply chain challenges and establish a deep understanding of how technology can realistically ease those burdens. Both workstreams were designed to create a vision and blueprint for the data, operational processes, business systems, and network connections required to realize DSCSA 2023 compliance and to digitalize pharmaceutical drug recalls.
The results from our pilot gleaned significant insights that will help solve different, but equally important challenges that the pharmaceutical industry will continue to face until DSCSA 2023, with both workstreams undoubtedly highlighting the value of a digital network in improving processes and efficiencies within the supply chain, said Shabbir Dahod, president and CEO of TraceLink. With the only established end-to-end digital supply network for the industry, TraceLink is in a unique position to help the industry begin acting on some of these pilot findings now. This includes improving processes and allowing better visibility, agility, and collaboration among supply chain stakeholders.
Product Recalls Workstream: Digital Recalls Across the Supply Network
Every year, drug related recalls play a significant role in the hundreds of thousands of preventable patient deaths and hospitalizations from adverse event experiences. In addition, a report published by McKinsey points to these recalls costing the pharmaceutical industry more than $4B+ in direct labor and recall management expenses; and tens of billions of dollars in potential product liability lawsuits, lost drug sales, and brand erosion.
Pilot participants in TraceLinks digital recalls workstream explored ways to solve challenges associated with todays product recall process, plagued by disjointed systems, manual processes, and long delays in communication between supply chain stakeholders including leveraging TraceLinks emerging digital recalls network solution
Participating in the recalls workstream further demonstrated how inefficient the current industry process is in executing product recalls, said Joe Maki, pilot participant and senior director of pharmacy operations, Novant Health. The learnings emphasized how a digital recalls platform could vastly improve the execution of recalls by eliminating manual, error-prone processes and would also help to better define accountability among supply chain stakeholders with improved collaboration¬¬¬¬¬¬¬, ultimately reducing the risk to patients by getting recalled product off the market faster.
The recalls workstream identified a strong opportunity to improve the drug recalls process with the integration of bi-directional communications and digital recall notifications to bolster response times across the execution phase, which would require a collaborative effort among industry stakeholders to create an effective blueprint and roadmap for adoption.
For more information on the key findings from the Product Recalls Workstream, view the executive summary.
2023 Traceability Workstream, TraceLinks Interoperable Blockchain Network Solution with Trace Histories
By 2023, DSCSA will require an electronic, interoperable system by 2023 to identify and trace certain prescription drugs. TraceLinks blockchain workstream evaluated existing information, processes, and systems to determine if and how they can meet 2023 DSCSA requirements. Pilot members analyzed the strengths and weaknesses of proposed electronic network models for DSCSA 2023, including the evaluation of TraceLinks interoperable blockchain solution to determine whether blockchain-centric and/or non-blockchain approaches may be effective.
Business processes related to product traceability are extremely complex due to the diversity of the pharmaceutical supply chain. The findings identified blockchain as one piece of a larger technology solution that could support product traceability under the DSCSA 2023 guidelines. However, the pilot strongly indicates that reliance on any single technology or sole platform to meet the DSCSA 2023 guidelines is extremely unlikely.
For more information on the goals and objectives, key findings, and takeaways from the 2023 Traceability Workstream, view the executive summary.
The full TraceLink FDA Pilot Project Program report is available on the companys website.