Analytical equipment interface testing

Diagnostics Self-Test for Analytical Equipment Interface... 

As with IQ, there will be a need for the validators of the analytical equipment interface to perform functional testing of the analytical equipment independently of the core LIMS supplier. Only when the analysis equipment has been demonstrated to function correctly should the equipment be coimected as a iive data source for the core LIMS. 

It is essential that any checks on inputs to the LIMS from the analytical equipment interfaces be verified. Where test equipment is used, calibration certificates (referencing national standards) must be referred to in the test documentation. 

The sample extract is injected into a HPLC containing a reverse phase HPLC column. The analytes are identified by comparing their retention times with that of the standard. A more reliable and confirmatory test is to use a mass spectrometer equipped with a particle beam and interfaced to the HPLC column. The compounds are identified from their mass spectra as well as retention times. The chromatographic column and conditions are described below. 

Proper functioning and performance of equipment play a major role in obtaining consistency, reliability and accuracy of analytical data. Therefore equipment should be properly selected, designed, installed, and operated, and the correct function and performance should be verified before and during operation. This holds for equipment hardware, computer hardware, hardware interfaces, and software and computer systems. Qualification of equipment hardware is well established and has been described by several authors [1-4], and typically users in analytical laboratories are quite familiar with testing equipment for hardware specifications. 

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