瑞士有一个IT技术专家组,成员来自产业界和GLP监管机构,在其撰写的《GLP-Guidelines for the Development and Validation of Spreadsheets》(2011年)中,有如下描述“Not included within the scope of these guidelines are spreadsheets employed as singleuse calculation sheets (a new file is created, data are entered and calculations are set up, e.g. mean and SD; the file is subsequently printed, dated and initialled). These spreadsheets need a QC check on completion (the calculation should be repeated with a calculator). If this kind of spreadsheet is used on a routine basis, validation according to these guidelines is recommended.” 与楼上McCaw的回答一致,使用电子表格计算,手工复核或者经验证。
关于这个问题,生产环节,有一个类似的情况供你参考。
可以抽空看一下识林里面的FDA CFR211 Sec. 211.68 Automatic, mechanical, and electronic equipment. —— (c) Such automated equipment used for performance of operations addressed by 211.101(c) or (d), 211.103, 211.182, or 211.188(b)(11) can satisfy the requirements included in those sections relating to the performance of an operation by one person and checking by another person if such equipment is used in conformity with this section, and one person checks that the equipment properly performed the operation. 特别是关于“verification by a second person”的理解;
另外一个是关于Sec. 211.103 Calculation of yield的要求。原话是“Such calculations shall either be performed by one person and independently verified by a second person, or, if the yield is calculated by automated equipment under 211.68, be independently verified by one person.”
它们情况和你这个问题类似,重要的是强调不管你采用什么自动化设备“生产”,需要有人复核。
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