Excel 用于计算和画趋势图
计算机化系统
请问,使用Excel 进行计算,如SD,我们要求进行手工计算确认,但不知是否必要?(计算器的计算功能也有类似确认) 另外,我们还会使用Excel进行趋势图分析,请问这种趋势图的绘制,如何进行确认或者控制?需要吗?
2015-12-29 10:56 悠悠     
3个回答

excel要进行验证,具体做法可从丁香园寻找。但问题是:你的excel是正版么?

2016-01-08 16:07 卓乞     

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。

2015-12-30 10:40     
2015-12-31 18:51

另外中国GMP指南上有一个关于电子表格验证的实例(质量控制实验室 4 物料和产品的检验 实例 5),也可以参考。

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)211.103211.182, 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。

 

2015-12-29 22:18 McCaw