Computer User Rights

The computer on which Clarity is installed must operate under the conditions where each user has individually defined access rights.

Caution:

In order to maintain good Data Integrity, staff operating Clarity (typically laboratory personnel) must not have any privileges to change Windows System Time on the computer running Clarity. If this condition is not met, the accuracy and integrity of timestamps Audit Trail can be compromised, since they are recorded as current Windows System Time in the moment of any action performed.

These settings may only be set by the system administrator, preferably during the computer installation. This feature, mandated by both 21 CFR Part 11 and GLP, has been tested and verified on the following operating systems: Windows 7 Professional, Windows 8.1 Pro, Windows 10 Pro and Windows 11 Pro. Here are some general recommendations on the computer system:

  • The computer where Clarity will be run must use only user accounts with specifically defined user privileges, as described in the following sections of this chapter. The administrator account should be reserved for IT personnel, who must not be involved in creating electronic records in Clarity, because administrator privileges allow access to data outside of Clarity without Audit Trail logging.
  • Each Clarity user should have their own individual Windows user account.

    • Caution:

    It is not possible to switch Windows users while Clarity is running. If taking over a running instrument is required, it is recommended to use one shared Windows user account for all Clarity users (that require this function).

  • All Windows user accounts must have defined access rights for the Cfg, DataFiles, and Bin subfolders within the Clarity installation directory. If the DataFiles folder has been renamed or moved outside the Clarity directory (for example, to a regularly backed-up network location), user privileges must be set in the same way as for the default folder. The data storage location can be modified via the System - Directories... command in the Clarity main window.
  • The data created by Clarity users must not be stored in Bin subfolder.

Note:

To further protect data integrity, the organization should implement internal measures to prevent accidental or unauthorized data changes by IT staff or other personnel with administrator privileges.