Installation Qualification
One of the requirements for ensuring the reliability of generated results is the validation of all instrumentation and procedures that are used to acquire data.
Levels of Qualification
For chromatography datastations, usually three levels of validation (qualification) are relevant:
Installation Qualification: a procedure confirming, that the datastation was successfully installed and that the installation contains all needed files of correct version. Installation qualification is an integral part of the Clarity Chromatography datastation installation procedure.
Operational Qualification: a procedure confirming, that the datastation is performing according to the manufacturer’s specification. Chromatography data are acquired and analyzed with prepared procedures and the acquired results are compared with expected values. System Suitability Test (SST) module is required for this type of qualification.
Performance Qualification: a procedure confirming, that the analytical system is fit for a given type of analysis. Usually, the overall system performance is tested by this procedure with respect to the requirements of the desired application. The Clarity datastation offers many tools in the System Suitability Test (SST) module to efficiently evaluate the system performance.
Installation Qualification of Clarity datastation
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Performing Installation Qualification of Clarity is very easy: it consists of launching the IQ Report via Help - IQ Report command in the main window of Clarity, printing the results and signing them. In case the overall result is "Failed", there is some inconsistency in files which are necessary for proper function of datastation. In that case the user has to check the list of files (in the lower part of page) and find the row containing a red coloured inscription in its Status field.
Possible messages in the Status field
Passed
The file is correctly installed and registered.
Warning: Unknown control module
Possible reasons:
- The control module is located and registered in a different folder than in the current installation. Other installation of Clarity was probably not correctly uninstalled. The solution is to find the old installation folder and delete it manually.
- The control module is located in the current installation folder, but registered for another EXE file than the current one. The uninstal.log file was damaged or corrupted in the previous installation and the files were not uninstalled. Find and delete all dll and ocx files from the current installation folder before a new installation.
- The file is located in the current installation folder, a control module not present in the installation was added and registered. No remedy needed when it was done on purpose, in other case delete the file manually.
In case this warning is displayed, the overall result of Installation Qualification will be "Passed (with warnings)". This means the installation was performed successfully and there is no file missing, however, there are some discrepancies and it is recommended to fix the problem with indicated files.
Failed: file does not exist
The file is registered but not physically present. Possible reasons:
- The previous installation was deleted without proper uninstallation. Clean up the registers for unused entries before a new installation.
- The file was deleted manually from the current installation.
Failed: bad size
File size does not match.
Failed: bad checksum
The module file is corrupted, its size or checksum differs from the proper value for particular version of Clarity datastation.
In case some of the files are displayed, the overall result of Installation Qualification will be "Failed". This means the proper function of the datastation cannot be guaranteed and the new installation is strongly recommended.
Failed: does not have record in certification file
The file is present in the default installation folder, however according to our certification file it is not supposed to be there, if it is a control module, it will trigger Unauthorized control module yellow stripe in the Instrument window.
Troubleshooting
In order to get "Passed" for IQ of your station, it is necessary to uninstall the old installation, then check for problem-causing files on your computer and, eventually, delete them manually. Exact suggestions are listed in Possible Messages section above. However, a general procedure consists of searching for the problematic files, deleting them and installing the station anew. After deleting the old files, cleaning of the Windows registry has to be performed. It is possible to search for the registry key dealing with the deleted file and remove it too, however, the easiest way is to use some software intended for cleaning the registry.