SOP - Setting the GLP Options

To configure Clarity for basis regulated environment conditions, follow these steps:

• Open Clarity. In the main Clarity window, use the System – GLP Options... command to enter the GLP Options dialog.

GLP Options

• To prevent loss of any data from chromatograms, check the Allow chromatogram GLP mode checkbox. This option prevents overwriting of existing chromatograms and ensures that a chromatogram is generated even if an analysis is aborted for any reason. Chromatograms created in GLP Mode can be edited only on Clarity stations where GLP Mode is also enabled; on other stations, they will open as read-only.
• To prevent any manual edits of response values in the Calibration window, check the Disallow calibration response change checkbox. Although manual changes are recorded in the Calibration Audit Trail, they break the link between the calibration standard and the calibration itself and can affect the results of chromatograms linked to that calibration file.
• To disable the display of all available User Names in the Login dialog, check the Disallow user list in login dialog checkbox. The user is then required to enter two unique identification components to successfully log in.
• To prevent users from being deleted or renamed in the User Accounts dialog, check the Disallow user deletion and renaming checkbox. This option ensures traceability and maintains integrity of user accounts.
• To require users to provide a reason for file changes, check the Ask for reason of file change checkbox. When saving or modifying a chromatogram, method, sequence, calibration or GPC calibration file or other Clarity settings (such as System Configuration or User Accounts), the Reason for Chromatogram (Method, Sequence, ...) Change dialog will appear, allowing the user to enter an explanation for the modification.

Reason for Chromatogram Change

To ensure that the field is not left empty, check the Disallow empty reason of file change checkbox — only reasons containing text are accepted. The reason is then logged in Audit Trail next to the Save file information.

• To automatically export the audit trail, check the Allow automated export of audit trail checkbox. The exported audit trail file is marked as read-only while Clarity is running and is continuously updated during the session. Although this feature is not required by any regulated environment standard, it can help QA personnel review audit trails without accessing Clarity directly.
• To disallow the use of Spike Filter and Spike Removal operations, check the Disallow spike filter and spike removal checkbox. These functions can significantly alter the signal and potentially remove peaks. Although their use is logged in the Audit Trail and visible in the Integration Table, disabling them helps protect data integrity.
• To prevent users from overwriting existing files, check the Disallow to overwrite existing files using save as and while exporting checkbox. This option applies to all Clarity files. If a user attempts to overwrite an existing file, a warning message appears and the file must be saved under a different name.
• To ensure that new chromatograms are saved only within the current project, check the Allow chromatograms to be stored to current project only checkbox. The setting supports data integrity by ensuring that files are created only in locations with controlled access, as described in the chapter "Computer User Rights". A detailed description of this option can be found in GLP Options of the Clarity main help.
• To disable the chromatogram merge operation, check the Disallow chromatogram merge operation checkbox. This prevents users from combining multiple chromatograms into a single new file.