GxP评估

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SN. 序号	Question 问题	Results 结果
1．	Does the system generate, process, or control the data used to support regulatory security and efficacy submissions? 系统是否生成、处理或控制用于支持法规安全性和功效提交文件的数据?	Yes是 ￡/No否 R
2．	Does the system control key parameters and data related to preclinical, clinical, development or production? 系统是否控制临床前、临床、开发或生产相关关键参数和数据?	Yes是 ￡/No否 R
3．	Does the system control or provide data or information about product release? 系统是否控制或提供有关产品放行的数据或信息?	Yes是 R/No否 ￡
4．	Does the system control data or information required in connection with product recalls? 系统是否控制与产品召回相关要求的数据或信息?	Yes是 ￡/No否 R
5．	Does the system control the recording or reporting of adverse events or complaints? 系统是否控制不良事件或投诉的记录或报告?	Yes是 ￡/No否 R
6．	Does the system support drug safety surveillance? 系统是否支持药物安全监视?	Yes是 ￡/No否 R

If the answer to any of questions 1 to 6 in the above 6 questions is "Yes", the system is a GxP key system; if the answer to questions 1 to 6 above is "No", then the system is GxP for non-key systems, the assessment process ends.

如果上述6个问题中第1~第6任何一个的答案为“是”，系统即为GxP关键系统；如果上述第1~第6个问题的答案均是“否”，那么该系统即为GxP非关键系统系统，则评估流程结束。

花园西路

谢谢楼主分享

九六书生

你这个不够有营养，可以把原资料分享出来，或者分享一个某个公司的模板。。。不过这两类在论坛里都有

xqliu

学习了，谢谢提供分享。

hyliukai77

学习学习。