Aging rig in medical device industry - To qualify or not

F

Fylgia

Registered
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.


  1. If you have similar equipment - do you qualify (IQ/OQ) or anything else?
  2. What did you base your decision on for how to treat the rig?
Thank you!
 
Ronen E

Ronen E

Problem Solver
Moderator
How can you be sure that the rig did what you intended it to do? I suppose no one sits there to supervise it while it works.
 
J

JJ_FDA

Involved In Discussions
I'm with Ronen. You need to qualify it - demonstrate that it does what you think it does.
 
Y

yodon

Leader
Super Moderator
I'll "third" Ronen's response and agree qualification is needed. You're making quality decisions based on the use of the equipment so you need to have confidence that the equipment is doing what's intended.

Further, since it has control software, the software itself should be validated!
 
F

Fylgia

Registered
Thank you all!

I actually think I can draw a parallel to the use of a climate chamber, which I would always qualify.
The chamber itself do not measure anything on the component, but I want to be sure it works as expected.

(Comment - the people voting for non-qualification will claim that it is not GxP and it can be controlled by calibrating sensors before and after test run to reassure it has performed as expected)

Cheers!
 
J

JJ_FDA

Involved In Discussions
Fylgia said:
the people voting for non-qualification will claim that it is not GxP and it can be controlled by calibrating sensors before and after test run to reassure it has performed as expected
Click to expand...

But does that not qualify :bonk: as a qualification test?
 
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