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System, method, and computer-readable medium for collection of environmental data and generation of user report for compliance with FDA requirements
System, method, and computer-readable medium for collection of environmental data and generation of user report for compliance with FDA requirements
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机译:用于收集环境数据并生成用户报告以符合FDA要求的系统,方法和计算机可读介质
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摘要
A system, method, and computer-readable medium for the collecting and storing of environmental data, and generating a user report of the environmental data, the user report providing document compliance with U.S. Food and Drug Administration requirements. The collected and stored environmental data includes a wide variety of manufacturing facility parameter data, including but is not limited to, the presence of viable microbiological organisms, the presence of particulates and other environmental conditions within the facility, such as humidity, pressure, temperature, water quality (e.g., pH, conductivity, total organic content (TOC), endotoxin, coliform, and metals), and the respective amounts of different materials involved in the manufacture of the end product(s).
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