Case Study

    Hudson Scientific standardizes pharmaceutical labeling and achieves DSCSA compliance in 30 days

    Loftware improves accuracy, reduces manual effort, and supports future growth

    概要


    Founded by FDA and ISO regulatory experts, Hudson Scientific LLC offers a seamless concept-to-market solution for medical device and drug companies. The organization supports pharmaceutical manufacturing and operates in a highly regulated environment where every drug must be traceable from manufacturing through to the end user.


    Managing serialized pharmaceutical labeling is essential to maintaining compliance and ensuring product integrity throughout the supply chain. Prior to implementing a new product identification solution, labeling processes were handled manually, creating inefficiencies and increasing the risk of human error. To improve operational productivity and support future expansion plans, Hudson Scientific contracted IPSi to deploy Loftware and standards-compliant traceability platform, TrackVision AI, as part of its pharmaceutical track-and-trace environment.

    Challenges


    Manual processes and server dependency

     

    Pharmaceutical manufacturers must be able to trace products from manufacturing through to the end user to meet DSCSA compliance requirements.

     

    Hudson Scientific specializes in small batch pharmaceutical runs, with each drug requiring multiple label designs. As its operations grew, manually controlling labeling and serialization became increasingly complex and inefficient, limiting the company’s ability to scale production and growth.

     

    Each batch required employees to generate unique serialization codes, create labels, print them, and individually verify each product manually by scanning every code to ensure accuracy and compliance. This approach required significant time, human involvement, and effort for every production batch. Despite these efforts, the process still left significant room for human error.

    As our pharmaceutical operations expanded, manual serialization and label verification became increasingly time-consuming and complex, creating a need for a more scalable, accurate solution.

    Yasser Sadek

    CEO, Hudson Scientific

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