Overview for Image Studio 21 CFR Part 11

If a system administrator has set up Image Studio 21 CFR Part 11 for your group, access to Image Studio will be restricted to users with a valid user name and password.

User access to software functionality and data is controlled through roles and groups assigned to the user. The System Manager controls Actions, Roles, and Groups as well as system settings.

• Actions - Actions are operations performed by users within the system.
• Roles - A role is a set of allowed actions. Roles are assigned to users to control which actions a user can perform. Users may have multiple assigned roles, and roles may have overlapping assigned actions.
• Groups - A group is a set of users. Groups are assigned to users to control which Work Areas users can access.
• Work Areas - Work Areas contain data and allow access to customized software settings and analysis presets.