Clarity INT9 A/D Uživatelská příručka Strana 18

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Clarity - Getting Started Qualification procedures
18
If the Installation Qualification fails, it is
recommended to uninstall and then re-install
Clarity. If it fails again contact DataApex user
support.
Note: The most common reason for obtaining a "Failed"
result of the qualification is due to the installation
of the station upgrade over an existing full version
of Clarity. This itself does not produce any errors
but since some of the files are preserved from the
original installation, the checksums will not fit.
The Installation Qualification report can then
be printed, copied to the MS Windows
Clipboard or sent as an email.
3.2 Operational Qualification - OQ
Operational Qualification (OQ) is a procedure
confirming that the data station is performing
according to the manufacturer’s specification.
The Operation Qualification is provided by
Validation kit, which consists of a precise peak
generator and a set of methods and reports used
in the validation process. SST module, an
optional extension of Clarity, is also necessary.
The Validation kit (p/n: CVK) can be
purchased separately, as well as SST
Extension (p/n: A22).
3.3 Performance Qualification - PQ
Performance Qualification (PQ) is 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 evaluation of the system
performance in Clarity is addressed using the
dedicated Extension System Suitability Test
(SST).
The SST module (p/n: A22) can be purchased
separately.
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