For all equipment it is necessary to establish documents defending the use.
The V-model described in the ICH-guidelines should be followed and this tells that the functionality should be described in URS, FS and DS (user requirement specification,
functional specification and design specification) and tested through FAT, SAT, IQ, OQ and PQ (factory acceptance test, site acceptance test, installation qualification, operational qualification and performance qualification).
I have used this model
for specifying, acquiring, and qualifying equipment for both chromatography and tangential flow filtration many times to ensure process functionality.