Challenges of Upstream Traceability for Life Sciences Supply Chains

The pandemic revealed weakness in global life sciences supply chains, from the shortage of personal protective equipment brought on by limited domestic production capacity to the difficulty of manufacturing and distributing vaccines on a global scale. What makes life science supply chains especially complex are the specialty raw materials and manufacturing processes used and the regulation that touches every link in the chain. The combination makes it difficult to find suppliers and even more difficult to change them in response to a disruption or a shift in demand.

The life sciences pioneered downstream traceability to follow products from manufacturing to customers, meeting regulatory requirements for quality assurance and ensuring that every patient is served along the way. Compared to the food and apparel industries, however, the life sciences have scant upstream traceability to the origins of raw materials. It’s time for the life sciences to adopt upstream traceability to ensure that supply chains are resilient and that they can be adapted to meet ever-changing needs.

Benefits of upstream traceability

  • Plan a resilient supply chain

Upstream traceability starts with supply chain mapping: the process of registering each of the stakeholders in the upstream supply chain into a common data-sharing platform. Mapping the supply chain reveals supplier concentrations and sole-sourcing that could make the supply chain vulnerable to disruption and merit the discovery of alternate suppliers or bolstering inventories, for example.

  • Ensure quality and authenticity

Once the supply chain is mapped, upstream traceability gathers transaction documents for every stage in the supply chain ensuring accountability for all volumes. Upstream traceability data is often used to ensure that raw materials are processed in a timely manner and that there is no leakage or injection of unauthorized materials at any stage in the supply chain.

  • Monitor risk and disruptions

The supply chain map is overlaid with real-time news on disruptions, and cross-checked against sanctions lists and risk heat maps to maintain a holistic view over the risk of the supply chain at any one time. Continuous risk and disruption monitoring buys valuable lead time when it comes to finding new suppliers and securing inventories in case of an adverse event at any tier of the supply chain.

  • Streamline regulatory reporting

Supply chain mapping and traceability automate the process of documenting supply chains for regulatory approval, a process that can otherwise take weeks when done manually. Add to that the need to obtain regulatory approvals from every country in which life science products are sold, and to respond to questions from regulators on demand, and upstream traceability quickly pays for itself.

For more information, get in touch with Sourcemap, the only provider of upstream traceability software for the life sciences sectors.

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[The New York Times] How A.I. and DNA Are Unlocking the Mysteries of Global Supply Chains