Clarity INT9 A/D Guía de usuario descargar pdf (Pagina 18)

Clarity - Getting Started Qualification procedures

• 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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Clarity INT9 A/D Guía de usuario Pagina 18