Validation of the method would not be applicable since it is used to qualify the instrument itself. 

Suppose you’re talking about LOD or LOQ of the HPLC method as a validation parameter, for example. You wouldn’t need to validate this parameter in the HSQ Kit™ method because its calculation first assumes that the detector is responding in an accurate manner; however, detector accuracy is one of the parameters that the HSQ Kit™ itself qualifies. Validation of this HPLC method is not required by any federal regulation. 

Please note that before you validate a method, you must complete IQOQPQ on the instrument.

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