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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

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

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).
机译:一种用于收集和存储环境数据并生成环境数据的用户报告的系统,方法和计算机可读介质,该用户报告提供符合美国食品药品管理局要求的文件。收集和存储的环境数据包括各种各样的制造设施参数数据,包括但不限于有活力的微生物存在,微粒的存在以及设施内其他环境条件(例如湿度,压力,温度,水质(例如pH值,电导率,总有机物含量(TOC),内毒素,大肠菌群和金属),以及最终产品制造中涉及的不同材料的各自含量。

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