Instrument qualification - FDA.COMs Community Forums

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Post: Instrument qualification (Topic#2906)

Anonymous

10-05-05 05:09 AM - Post#2906

Hello,
For instrument qualification, does it matter if the instrument is already setup or not? we are using an outside vendor to do this qualification and according to them we should have it already setup and then they will do the IQ etc. would appreciate any input.

thanks

acw
stranger
Posts: 6

10-05-05 07:18 AM - Post#2909

In response to Anonymous

Set it up, but make sure you attach a "Do Not Use" sign on it, so it cannot be mistaken for an in use system.

Anonymous

10-09-05 12:57 PM - Post#2941

In response to acw

IQ's generally deal with installing and setting things up, even to the point of dealing with unpacking and removing transit screws etc, as this can damage the equipment if not done correctly. So you should look at the IQ document and see just whats in it. It seems to me that IQ should be referenced as part of the set up. Are you sure that the vendors are familiar with the IQ/OQ process?

Regards
PaulS