The Validation Kit (p/n CVK) is designed to perform the Operational Qualification of the Clarity Chromatography stations that acquire data using the A/D converters internal PCI cards INT7, INT9 or external USB boxes Colibrick, U-PAD, U-PAD2.
An optional SST Extension is necessary for data evaluation.
Using a precise peak generator, chromatographic data is acquired and analyzed with prepared procedures and the acquired results are compared to expected values.
OQ validation of Clarity software with digital data acquisition (if the A/D converter is not used) uses Virtual Detector, in such case the Validator hardware is not required.
The Validation Methodology can be ported to different software and hardware solutions. Implementation of the procedures described in the Validation kit manual into procedures specific to the software being used is required.