GLP Options
This dialog is used to set the global regulated-environment connected options. After prompting the System - GLP Options… command, the user is asked to enter the password for the Clarity station. Only users allowed to modify the User Accounts (for more details see also chapter User Accounts) are allowed to enter this dialog. All changes performed in this dialog are logged into the station audit trail.
This checkbox ensures that settings preventing the possibility of losing the data from chromatograms are correctly set. If checked, both the Disallow Chromatogram Files Overwriting and Generate Chromatogram After Abort checkboxes will be checked. Chromatograms acquired by an Unauthorized Control Module or by a Development version of Control Module, will contain record in the Chromatogram Audit Trail about the fact that they were acquired by such a device in order to comply with GLP.
Note:
If you open a chromatogram created in GLP Mode in Clarity without enabled GLP Mode, it will be always opened as read-only.
Disallow chromatogram files overwriting
This checkbox cancels the possibility to overwrite the chromatogram if a file with the same name already exists in the selected directory. The behavior differs according to the action that should cause the chromatogram to be overwritten - when it is a user action (using the Save As command for example), the user will be prompted to change the file name to any still unused file name. If the overwriting should be caused by the Clarity data acquisition (e.g. creating new chromatograms caused by Single Analysis or Sequence measurement), a unique 4- to 6- digit number is added at the end of the original filename. In the improbable case that all of these combinations are already taken, the Clarity will ask the user to change the file name personally so it is unique.
Generate chromatogram after manual Abort
This feature will cause the generation of the chromatogram in case the analysis is aborted manually by user.
Note:
If the analysis is aborted by an error, Chromatogram is always generated, regardless the checkbox settings.
Disallow Calibration Response change
When checked, the manual change of the response in the Calibration window is disabled.
Note:
The manual change, if allowed, is still marked in the Calibration Audit Trail, but it breaks the link between the calibration standard and the calibration itself and is not recognizable in the chromatogram linked to the calibration file.
Disallow user list in Login dialog
This checkbox disables the display of all available User Names in the Login dialog. The user is then required to enter two unique identification components to successfully log in.
The Ask for Reason of File Change checkbox sets the possibility to fill in the reason for a change. When saving a chromatogram, method, sequence, calibration or GPC calibration file, the Reason for Chromatogram (Method, Sequence, …) Change dialog will appear. The user can (but is not obliged to) fill in the reason for the change.
Reason for Chromatogram Change
Note:
The reasons of changes are displayed in the Audit Trails, separated by a dash from the „file has been saved“ event.
Disallow empty reason of file change
By checking this checkbox the user becomes obliged to fill in the reason of the change. No empty reason field nor reasons solely composed from spaces are now allowed.
Allow automated export of Audit Trail
By checking this checkbox the station audit trail file will be automatically exported to the file and location specified in the File Name field. To set the appropriate location, use the button to browse to the desired directory.
Changes to this export file will be made continuously and the exported file will be marked as read-only for as long as the Clarity is opened.
Disallow Spike Filter and Spike Removal
By checking this checkbox the Spike Filter and Spike Removal functions from the Chromatogram window will be disabled. These are potentially dangerous operations to work with in respect to the GLP practice. The operations are only available in Clarity version 4.0 or higher.
Disallow to overwrite existing files using Save As and while exporting
By checking this checkbox users are prohibited to overwrite any existing file. This feature applies to any file (method, calibration, chromatogram, etc.) created by Clarity, as well as exporting a file over an existing one - the user must save it under a different filename. Exporting in form of appending to the existing file is still allowed.
Allow chromatograms to be stored to current project only
Option Allow Chromatograms to Be Stored to Current Project Only allows storing any newly generated chromatogram within one of working directories (typically Data or Calib) of current project only.
This feature disables:
- storing any newly generated chromatogram outside of working subfolders (typically Data or Calib) of current Project,
- storing any newly generated chromatogram directly into root of current Project,
- automated creating of new subfolders directly in root of current Project.
This feature is intended as support of data integrity because it will disallow creating data in destinations where might not be applied measures against uncontrolled data deletion or alteration.
During defining destination for newly generated chromatogram Clarity essentially constantly evaluates user's input where to store new chromatogram and provides feedback to user. The feedback provided to user in Single Analysis is done through the text above Chromatogram File Name field. When given destination is allowed it is in standard black color, if it is prohibited it is displayed in red.
Single Analysis - Allow Chromatograms to Be Stored to Current Project Only - Prohibited Destination
Single Analysis - Allow Chromatograms to Be Stored to Current Project Only - Allowed Destination
When user tries to start analysis with prohibited destination defined, Clarity will deny to start analysis and will display related error message. The user has to adjust currently defined destination to allowed one in order to run measurement in Clarity.
Single Analysis - Allow Chromatograms to Be Stored to Current Project Only - Prohibited Destination - Error Message
The feedback provided to user in Sequence about prohibited destination is done through indication in the Status column for incorrect input. If currently defined location for new chromatogram directs outside allowed destination in current project Clarity will prevent user from triggering any new analysis and will display respective error message. This event will be also recorded in Audit Trail.
Sequence - Allow Chromatograms to Be Stored to Current Project Only - Prohibited Destination
Sequence - Allow Chromatograms to Be Stored to Current Project Only - Prohibited Destination - Error Message
Following image provides review what are allowed destinations and what is prohibited destination within current project folder.
Allow Chromatograms to Be Stored to Current Project Only - Destinations
In case of unexpected external start of analysis when there is incorrect location defined Clarity will apply internal fallback mechanisms and will try to store new chromatogram within subfolder (i.e. Data or Calib) of current project. This exceptional case will be specifically recorded in Audit Trail as well.
Audit Trail - Allow Chromatograms to Be Stored to Current Project Only - Fallback Mechanism
The option Allow Chromatograms to Be Stored to Current Project Only should also be used if it is planned to transfer given Project among various computers. This option will ensure that all related files are stored in the project folder, meaning that no data will be lost during the transfer.
If the option Allow Chromatograms to Be Stored to Current Project Only is not used, it is possible to define basically any (local or networked) location for a newly generated chromatogram. However, sticking to the Clarity project structure and avoiding using absolute paths for storing chromatograms is recommended. If it is still desired to save a new chromatogram to a specific location, keep in mind that Clarity (and Windows user) needs write access to the location. Typical examples of problematic destinations are root folder of the system hard drive (e.g., C:\) or root folder of server (e.g., \\server\).
Disallow Chromatogram Merge operation
By checking this checkbox users are prohibited to use Merge operation.