Computer User Rights

The computer on which Clarity is installed must operate under the conditions where every user has their own defined rights.

These settings may only be set by the system administrator, preferably during the installation of the computer. This feature is required by 21 CFR Part 11 and GLP. Here are some general recommendations on the computer system:

Note:

These are not given in the way of comprehensive SOP applicable on every computer, as the computer system and general company conditions on this field may differ widely. However, the SOP provided was tested to work on four selected computer operation systems - Windows 7 Professional, Windows 8.1 Pro, Windows 10 Pro and Windows 11 Pro.

  • The computer where Clarity will be run must use only user accounts with specifically set user privileges that is described in the following subheads of this chapter. The user account with administrator privileges should be reserved for the company IT personnel who mustn't be involved in creation of electronic records by Clarity. The reasoning of these specific settings is described in the Note below this section.
  • Each Clarity user must have it's own user account on the operating system.
  • All of these user accounts for Clarity users must have set privileges for Cfg, DataFiles, and Bin subfolders in Clarity folder. If default name of the subfolder DataFiles in Clarity folder is changed or the this folder is located outside Clarity folder (for example on a regularly backed up network drive), the user privileges have to be set in the same manner as in case of default name or location of this subfolder. The modification of the location of DataFiles folder, where the data created by Clarity will be stored, can be set from Directories... item in the System Menu, which is accessible from the Clarity Main window.
  • The data created by users of Clarity must not be stored in Bin subfolder.

Note:

This whole process will ensure that the computer user or users will not be able to alter or delete any data created by Clarity outside Clarity environment. The only way how to modify the data is doing that from the Clarity environment, where operations are logged. As local IT personnel must have Administrator privileges they still have privileges to modify or delete data outside Clarity environment and without any logging by Clarity audit trails therefore there must be established different kind of protection to prevent any potential mistakes or missuses of local IT personnel. Local IT department and all other personnel and management (such as QC, QA etc.) must be aware of this fact.