You must exercise appropriate controls to assure that changes to computerized MPCRs or other CGMP records or input of laboratory data into computerized records can be made only by authorized personnel (§ 211.68(b)). Other examples of records for which control should be restricted to authorized personnel include automated visual inspection records, electronic materials management system records, and automated dispensing system weighing records. FDA recommends that you restrict the ability to alter specifications, process parameters, data, or manufacturing or testing methods by technical means where possible (e.g., by limiting permissions to change settings or data).

你必须采取适当的控制以确保对计算机化MPCR或其它CGMP记录的更改，或将实验室数据输入计算机化记录，仅能由经授权人员执行（§ 211.68(b)）。其它应仅限于经授权人员的记录示例包括，自动灯检记录、电子物料管理系统记录和自动配药系统称量记录。FDA建议，如果可能，通过技术手段限制对标准、工艺参数、数据，或生产或检验方法的更改（例如，限制设置或数据的更改权限）。

The system administrator role, including any rights to alter files and settings, should be assigned to personnel independent from those responsible for the record content. To assist in controlling access, it is important that manufacturers establish and implement a method for documenting authorized personnel’s access privileges for each CGMP computer system in use (e.g., by maintaining a list of authorized individuals) (see § 211.68(b)).

系统管理员角色 (包括更改文件和设置的任何权限) 应分配给独立于对记录内容负责的人员。为控制访问, 生产商必须建立并实施一种方法，用于记录授权人员对使用中的每个CGMP计算机系统的访问权限（例如，通过维护授权个人的列表）（参见§211.68（b））。