168
Data Management Software & Interface
Data Apex
III. Instruments
Clarity Validation Kit for Operational Qualication
Clarity Validation Kit:
Operational qualication tests:
Clarity Validator (precise analog signal generator device)
Clarity Validation Kit Manual
CD with all les necessary for performing the Operational Qualication
Cables
Retention time precision and accuracy
Voltage (peak height) measurement precision and accuracy
Area determination precision and accuracy
Calibration and calculations - ESTD and ISTD methods
Consistency of acquisition ranges
The quality of analytical data is an issue gaining increased atten-
tion in many laboratories today. One condition for ensuring the
reliability of generated results lies in the validation of all instrumen-
tation and procedures used for the acquisition of said data.
Commonly, three levels of validation (qualication) are relevant for
chromatography data stations:
Installation Qualication:
a procedure conrming that the datastation was successfully in-
stalled and that the installation contains all the required les of the
correct version. Installation qualication is an integral part of the
Clarity Chromatography datastation installation procedure.
Operational Qualication:
a procedure conrming that the datastation is performing accord-
ing to the manufacturer’s specication.
The Clarity Validation kit serves this purpose.
Using a precise peak generator, chromatographic data is acquired
and analyzed with prepared procedures and the acquired results
are compared with expected values.
Performance Qualication:
a procedure conrming that the analytical system is t 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 data station oers many tools in the System Suitability
Test (SST) module to eciently evaluate the system performance.
The Clarity Validation Kit is designed
to perform the Operational Qualication
of the Clarity Chromatography Station (version 2.2 or higher)
with INT7 or U-PAD A/D converters.
An optional Clarity SST module is necessary for data evaluation.
The kit is primarily intended for trained service personnel, who
regularly perform validations of chromatography systems using
Clarity data stations. However it can also be used by experienced
users for in-house validations. the operator must be familiar with
Clarity datastation operations.
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