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How does FDA use the terms “static” and “dynamic” as they relate to record formats?

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kk444555 一阶会员 用户来自于: 广东省深圳市
2023-10-17 21:49

For the purposes of this guidance, static is used to indicate a fixed-data record such as a paper record or an electronic image, and dynamic means that the record format allows interaction between the user and the record content. For example, a dynamic chromatographic record may allow the user to change the baseline and reprocess chromatographic data so that the resulting peaks may appear smaller or larger. It also may allow the user to modify formulas or entries in a spreadsheet used to compute test results or other information such as calculated yield.

就本指南而言,静态用于表示固定数据的文件,例如纸质记录或电子图像,动态指记录形式允许用户和记录内容之间进行交互。例如,动态色谱记录可以允许用户更改基线、重新处理色谱数据从而使得所得到峰可能更大或更小。还允许用户修改电子表格中用于计算测试结果或其它信息(例如计算出的结果)的公式或条目。


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发布时间
2023-10-17 21:48
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2023-10-17 21:49
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