金币
UID179204
帖子
主题
积分353
注册时间2014-8-7
最后登录1970-1-1
听众
性别保密
|
欢迎您注册蒲公英
您需要 登录 才可以下载或查看,没有帐号?立即注册
x
本帖最后由 溜溜达达 于 2024-9-5 13:07 编辑
PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
11.200 (a)(1)(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.
GAMP SIG Complying with 21 CFR Part 11 (Final Draft)
请教各位同仁:
对于电子签名2个要素(ID和密码)的应用场景:
21 CFR Part 11 原文中用的during a single, continuous period of controlled system access
GAMP 解读用的if session has not been continuous
是理解成:一次系统访问期间,首次电子签名需要用户ID和密码,之后系统可带出用户ID,只要求输入密码?还是一个连续的业务场景,而非一次系统登录呢?
|
|