1
关注
1123
浏览

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

您还未登录!暂时最多只可查看 1 条回答

登录! 还没有账号?去注册

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。


关于作者

问题动态

发布时间
2023-10-17 21:48
更新时间
2023-10-17 21:49
关注人数
1 人关注

相关问题

HASH值是什么?,怎么获取医疗器械软件的HASH值?
How can I obtain the impurities listed in a monograph?
如何实施OHSAS18000认证?
Are Health-Based Exposure Limits (HBELs) required for all medicinal products?
医疗器械检验机构的CMA和CNAS资质有何区别?
How do the new requirements affect importers of medicinal products?
Is it necessary to associate EMC test report withelectrical safety test report?
How to determine the naming rules for softwareversion?
How can I find out the expiry date of an EDQM reference standard?
When does electronic data become a CGMP record?

推荐内容