Thanks to every body, fo r your comments:
We have done the IQ and OQ validation for the system in general, I mean, we just check that all the intsrumentation and hardware was installed and is working according with the hardware disign specification, and we check that the software is working according with the functional specifications and URS.
Actually the system is in production because our regulatory agency, in the past year, didn’t have any regulation for software, but in this year they started with CSV.
And we will take your recomendations of doing a risk assessment and the supplier assessment as soon as posible.
If you guys have mor comments to do, I will apreciate.