We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • INDUSTRY PRESS ROOM
  • SUBMISSIONS
  • MEDIA FILE
  • Create Account
  • Sign In
  • Sign Out
  • My Account
Free Newsletters
  • MAGAZINE
    • Current Issue
    • Archives
    • Digital Edition
    • Subscribe
    • Newsletters
  • STRATEGY
  • GLOBAL
  • LOGISTICS
  • MANUFACTURING
  • PROCUREMENT
  • VIDEO
    • News & Exclusives
    • Viewer Contributed
    • CSCMP EDGE 2022 Startup Alley
    • Upload your video
  • PODCAST ETC
    • Podcast
    • White Papers
    • Webcasts
    • Events
    • Blogs
      • Reflections
      • SCQ Forum
    • Mobile Apps
  • MAGAZINE
    • Current Issue
    • Archives
    • Digital Edition
    • Subscribe
    • Newsletters
  • STRATEGY
  • GLOBAL
  • LOGISTICS
  • MANUFACTURING
  • PROCUREMENT
  • VIDEO
    • News & Exclusives
    • Viewer Contributed
    • CSCMP EDGE 2022 Startup Alley
    • Upload your video
  • PODCAST ETC
    • Podcast
    • White Papers
    • Webcasts
    • Events
    • Blogs
      • Reflections
      • SCQ Forum
    • Mobile Apps
Home » TraceLink FDA DSCSA Pilot Program Results Prove Value of Digitalized Pharmaceutical Supply Chain
Press releases are provided by companies as is and have not been edited or checked for accuracy. Any queries should be directed to the company issuing the release.

Upload your press release

TraceLink FDA DSCSA Pilot Program Results Prove Value of Digitalized Pharmaceutical Supply Chain

TraceLink FDA DSCSA Pilot Program Results Prove Value of Digitalized Pharmaceutical Supply Chain
June 23, 2020
No Comments

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 Gartner's 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 TraceLink's digital recalls workstream explored ways to solve challenges associated with today's product recall process, plagued by disjointed systems, manual processes, and long delays in communication between supply chain stakeholders including leveraging TraceLink's 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-- https://bit.ly/2VeRPn4.

2023 Traceability Workstream, TraceLink's 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. TraceLink's 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 TraceLink's 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-- https://bit.ly/2CzRIvP.

The full TraceLink FDA Pilot Project Program report is available on the company's website. Access the full report, here: https://bit.ly/2YZZ0jT.

https://www.tracelink.com/
Submit your logistics, material handling, or supply chain related company news in Supply Chain Quarterly's's Industry Press Room section or New Products section
Global Manufacturing Technology
KEYWORDS TraceLink
    • Related Articles

      TraceLink's Q2 2019 Results Are Indicative of Larger Supply Chain Industry Shift

      Averitt Releases 2021 “State of the North American Supply Chain” Survey Results

    You must login or register in order to post a comment.

    Report Abusive Comment

    Most Popular Articles

    • Report: Sagging freight stats show that trucking sector is returning to its historic mean

    • Survey: parcel delivery drivers are frustrated by using their own smartphones for work

    • Heavy transport across two continents

    • Survey: most Americans unaware that truckers face shortage of parking spaces

    • Supply chain executives not yet seeing expected results from technology investments

    Featured Video

    Household goods customs broker thumb

    Household Goods Customs Broker

    Viewer Contributed
    Household Goods Customs Broker :Gallagher Transport International is a highly experienced customs broker specializing in household goods, providing efficient and cost-effective customs clearance services while ensuring compliance with all necessary regulations. Our Services Include: Importing & Exporting...

    FEATURED WHITE PAPERS

    • Three layers of forklift safety: Promoting operating best practices

    • The Complete Guide to Automated Packaging

    • Five tips for parcel success in 2023

    • Guide to Pallet Rack Safety

    View More

    Subscribe to Supply Chain Quarterly

    Get Your Subscription
    • SUBSCRIBE
    • E-NEWSLETTERS
    • ADVERTISING
    • CUSTOMER CARE
    • CONTACT
    • ABOUT
    • STAFF
    • PRIVACY POLICY

    Copyright ©2023. All Rights ReservedDesign, CMS, Hosting & Web Development :: ePublishing