When login credentials are shared, a unique individual cannot be identified through the login and the system would not conform to the CGMP requirements in parts 211 and 212. FDA requires that system controls, including documentation controls, be designed in accordance with CGMP to assure product quality (e.g., §§ 211.100 and 212.50). For example, you must implement documentation controls that ensure that the actions as described in question 4 are attributable to a specific individual (see §§ 211.68(b), 211.188(b)(11), 211.194(a)(7) and (8), and 212.50(c)(10)).

当使用共享账号，无法通过登录识别唯一的个人，并且系统也不符合Part211和Part212的CGMP要求。FDA要求系统控制，包括文件控制，应按照CGMP（(例如, §§21.100 和 211.100)）设计以确保产品质量 。例如，你必须实施文件控制，以确保问题4中描述的操作可追溯至特定的个人(见 211.68(b)、211.188(b)(11)、211.194(a)(7) 和 (8) 和 212.50(c)(10))。

Shared, read-only user accounts that do not allow the user to modify data or settings are acceptable for viewing data, but they do not conform with the part 211 and 212 requirements for actions, such as second person review, to be attributable to a specific individual.

共享账户，但是不允许用户修改数据或设置的只读帐户以查看数据是可以接受的, 但它们的某些活动(如第二人审核)，是不符合第211和212部分关于可追溯至特定个人的操作要求的。