Cold chain logistics has become a core link in ensuring drug quality and safety, especially for temperature sensitive drugs such as vaccines and biologics. This paper aims to develop a drug cold chain transportation risk assessment and early warning system based on big data, utilizing advanced technologies such as big data analysis and machine learning to achieve real-time monitoring, intelligent analysis, and early warning of various risk factors in the drug cold chain transportation process. This paper proposes a comprehensive architecture that includes data collection layer, data transmission layer, data processing and storage layer, analysis engine, warning and response module, user interface, and system integration interface. This paper collects key environmental data in real-time through sensors, such as temperature and humidity, and uses a secure data transmission layer to transmit the data to the central processing system. The construction of the risk assessment model is based on a series of quantifiable risk indicators, including temperature deviation, humidity deviation, location deviation, etc., and through data standardization and weight allocation, combined with a machine learning model to perform risk scoring and grading. The early warning mechanism implementation part includes early warning rules and threshold settings as well as real-time monitoring and dynamic warning to ensure that the system can respond to potential risks in a timely manner. The results of the system performance evaluation show that the risk evolution prediction deviation rate remains at a very low level, with a maximum of 1.4%, the false alarm rate is very low, with a maximum of 0.15% and a minimum of 0.03%, and the risk situational awareness sensitivity coefficient remains at a high level, with a minimum of 0.8. These results indicate that the developed system performs well in terms of risk prediction accuracy, warning timeliness and risk perception sensitivity.
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