FDA 21CFR Part 11 Audit Events
The following is a list of the different audit events that are generated for FDA 21 CFR Part 11 compliance when the feature is enabled. It is an optional feature enabled on a per-client basis, please contact sales for more information or to have it activated.
- Action added
- Action deleted
- Action modified
- Action step added
- Action step deleted
- Action step modified
- Alert added
- Alert condition added
- Alert condition deleted
- Alert condition modified
- Alert deleted
- Alert modified
- Alert notification group added
- Alert notification group removed
- Certificate added
- Certificate deleted
- Confirm action failed - invalid e-mail or password
- Confirm action failed - not authorised
- Document electronically signed
- Login failure - account locked out
- Login failure - incorrect password
- New user account created
- Node access granted to user
- Node access revoked from user
- Node added
- Node calibration performed
- Node command sent
- Node deleted
- Node input label added
- Node input label deleted
- Node input label modified
- Node modified
- Notification group added
- Notification group deleted
- Notification group member added
- Notification group member changed
- Notification group member removed
- Notification group modified
- Roles granted to user
- Roles revoked from user
- Scheduled job added
- Scheduled job deleted
- Scheduled job modified
- User confirmed action with password
- User details added
- User details deleted
- User details modified
- User has asked for resend of e-mail confirmation
- User has changed password
- User has confirmed e-mail
- User has confirmed e-mail change
- User has initiated forgotten password request
- User has logged in
- User has logged out