21 CFR part 11使用范围的疑问

红耳仙僧

Under the narrow interpretation of the scope of part 11, with respect to records required to be maintained under predicate rules or submitted to FDA, when persons choose to use records in electronic format in place of paper format, part 11 would apply. On the other hand, when persons use computers to generate paper printouts of electronic records, and those paper records meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their regulated activities, FDA would generally not consider persons to be "using electronic records in lieu of paper records" under § 11.2(a) and 11.2(b). In these instances, the use of computer systems in the generation of paper records would not trigger part 11.

上面是FDA关于PART 11使用范围和应用的指南，这么理解的话，那目前国内好像没有多少是part11适用范围了。大部分都是使用电脑将记录打印出来的纸质报告作为法规符合性的数据，大家是怎么理解的呢？请大家赐教。

jiangbj

能避免的都尽量避免了

红耳仙僧

jiangbj 发表于 2019-6-24 15:25
能避免的都尽量避免了

如果都避免了，就不用符合part 11了，

红耳仙僧

自己顶起来。

相约酒吧as

这个原话出自哪里？