A question on validation methodology, and what should be in a user
We have a large chromatography client-server application in the lab
where the system consists of 40 client computers each with various
hardware components (i.e. lab consists of 5 different types of hplc
pumps/autosamplers, 4 different detectors…so there are many different
combinations per client…all models are supported by the vendor
software). Since the `system’ consists of hardware and software, my
user requirements would have the software application requirements
(reporting, audit trails, security, etc) and hardware requirements
(operating parameters for each different pump model and detector
In terms of timelines, we need to start rolling out the system as
fast as possible instead of having to validate this system with 40
clients as a whole. I’m thinking to validate the software with 1
client configuration (instead of all 40 clients). Release the
system, and implement the 39 other systems under change control.
These subsequent system implementations wouldn’t require any software
testing as that was done in the first system, so only a software IQ
and full equipment qualification for that client.
So I have a issue, if I do this, my user requirements has
requirements for 9 pieces of hardware. However, I’ve released a
system with 1 representative combination (pump A, detector A) of
hardware. Therefore my trace matrix for detector B,C,D will have no
testing. These other devices will be tested when those components
are implemented per change control; however, what do I write in the
trace matrix until then?
Has anyone taken this approach and have suggestions/criticism?