Hi,
I need some help in my thinking and to do some bench marking.
I'm working with medical device and in R&D we do component verification.
Part of component verification is to do stress tests / aging tests where the components are exposed to cold/heat/chemicals/pressure etc using a purpose built test rig. The rig is built upon calibrated sensors and a control software.
If the test rig would gather any measurements I gladly classify the rig as GxP and thus be subject to qualification (validation) according to our procedures.
However, the rig does not take any measurements or gather any results. It purpose is only to expose the components during a predetermined time.
I need some help in my thinking and to do some bench marking.
I'm working with medical device and in R&D we do component verification.
Part of component verification is to do stress tests / aging tests where the components are exposed to cold/heat/chemicals/pressure etc using a purpose built test rig. The rig is built upon calibrated sensors and a control software.
If the test rig would gather any measurements I gladly classify the rig as GxP and thus be subject to qualification (validation) according to our procedures.
However, the rig does not take any measurements or gather any results. It purpose is only to expose the components during a predetermined time.
- If you have similar equipment - do you qualify (IQ/OQ) or anything else?
- What did you base your decision on for how to treat the rig?