Bioequivalence and Bioavailability Forum

Hi,
there is an instrument which was used for analysing the samples of submission studies.
As there was no study available to be performed in this particular instrument in near future, management is decided to remove the instrument from the CRO and is planing to install it in different department where it can used further.

Can anybody suggest us the answer for following concerns

1. what is the impact on submitted studies considering that we are having soft copy data on the system as well as in archive
   
2. Whether regulatory body is going to accept it if they come for inspection
   
3. is it mendetory to be kept the instrument till the inspection is over.
   
4. with what precaution/ documentation we can shift the instrument.

Thanx
Auditor