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Can Blockchain be used to verify the 'Chain of Custody' in Quality Control for Pharma?


In the pharmaceutical industry, the integrity of the cold chain is vital. I am looking into using Blockchain to log temperature data from IoT sensors during transport. How do we ensure that the data on the ledger is a 'Single Source of Truth'? What are the challenges of integrating a private Ethereum or Hyperledger Fabric network with our existing LIMS (Laboratory Information Management System)?


   2025-11-20 in Blockchain by Lisa Ray | 6433 Views


All answers to this question.


Blockchain is ideal for pharma because it provides an immutable audit trail. To ensure the "Single Source of Truth," you need to bind the physical product to its digital twin using a serialized 2D barcode or RFID tag. The IoT sensors should ideally be "Identity-Linked" to the blockchain, signing their data with a unique private key. Integrating with your LIMS requires a middleware layer (or an Oracle) that can push data from the lab directly to the smart contract. The biggest challenge is 'Data Governance'—deciding which stakeholders (manufacturer, carrier, hospital) can see which parts of the data while maintaining trade secrets.

   Answered 2025-11-22 by Margaret White


hat happens if an IoT sensor fails or gives a false reading? Does the 'Immutable' nature of the blockchain then become a liability for the Quality record?

   Answered 2025-11-24 by Steven Wright

  • Steven, that’s where "Smart Contract Logic" comes in. You don't just log one data point; you log a consensus of sensors or a range. If one sensor is an outlier, the smart contract can flag it for investigation rather than automatically rejecting the batch. As for the 'Immutability,' you never "delete" the bad data, but you can append a 'Corrective Action' block that explains the sensor failure and provides the manual override evidence. This is actually better for an auditor because it shows the full history of the problem and the resolution, rather than just a "cleaned-up" final report.

       Commented 2025-11-25 by Paul Robinson


We are testing Hyperledger Fabric for this because the 'Private Channels' allow us to share quality data with the regulator without showing our shipping costs to our competitors.

   Answered 2025-11-26 by Karen Scott

  • Karen's point on Hyperledger is key for Pharma. Privacy is everything, and being able to segregate the 'Quality' ledger from the 'Commercial' ledger is a must-have feature for any enterprise.

       Commented 2025-11-27 by Lisa Ray



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