Enterprise IT solution powered by Blockchain and IoT with alignment to FMD & DSCSA regulations
Bosch Pharmatrace is an interoperable enterprise IT solution powered by Blockchain and IoT, built to equip its customers with strict alignment to the FMD & DSCSA regulations.
The solution is of great importance for the pharmaceutical industry due to the growing problem of counterfeiting - affecting both patient lives and revenue losses to the pharmaceutical companies.
The solution focuses on the following key modules:
• Track and Trace of prescription medicines: The use case uses the unique serialization number of each package to track it along the entire supply chain, across the stakeholders using the Pharmatrace solution. Counterfeits are detected by alert flags raised by the system on scanning of the fake drug barcode. A real time verification and validation of registered assets with the manufacturer’s database thereby ensuring robust leakage detection and control mechanism
• Saleable Returns / Verification: The verification of serialization data at one or more stops along the supply chain is key to ensure leakage & counterfeits are avoided. Pharmatrace provides real time, secure verification of the product returned by the pharmacy to the distributor/wholesaler. Pharmatrace provides interoperability so that wholesalers and distributors can easily verify barcodes with the database and flags as well as logs transactions that are suspicious.
• Condition monitoring: The Pharmatrace Blockchain platform is capable of interacting with the condition monitoring IoT device placed in the cold storage containers - large cold storages, refrigerators, vehicles, etc. This use case is relevant for drugs that need to be stored under prescribed temperature, pressure, humidity, etc. E.g. Vaccines, photosensitive drugs. In case of any breaches, Pharmatrace’s autonomous agents raise flags, log into the system and reports it to the relevant stakeholders. The in-built track and trace mechanism then allows removal of spoiled medicines from the supply chain system.
• Certificate management: The use case ensures digitization of compliance certificates and supply chain documents like invoices, e-bill of lading, title of ownership, customs clearances, bank letters of credit etc.