Thanks for the quick reply here. Forget about what the system WAS going to be used for and lets concentrate on the system that IS installed and IS in use. The fact remains that the critical parameters (Temperature,RH and indirectly, Fan speed) can be altered at anytime without anyone knowing.
Just to answer the questions that meyert put forward,
How will they monitor temperature, humidity and pressure differentials in the building? Will you use electronic records from the BMS to support your Environment? Manual monitoring from calibrated gauges will be the primary quality record
Are these environmental parameters considered critical to product quality? Yes
Will there be alarms in system? Yes, all the critical parameters are monitored and alarm limits have been set
How will you react to alarms? Contacting of the correct personnel for the specified alarm
Will the BMS be controlling airflow to classified air space? I know of course it will.
If you make a change to the system, do you need a change control that includes QA approval? No, and this is where I have a huge problem and cannot get buy-in
Will you be controlling door interlocks with the BMS? Why do you have door interlocks? No, the door interlocks are controlled via another system.
Do you validate WFI or clean steam? Yes
Do you control temperature, humidity and/or pressure? Why?Yes, via the AHU control and the BMS
As can be seen, nothing is misleading here whatsoever!
And now to come back to my original question of 'Has anyone perform a risk assessment on a BMS and is willing to pass a few tips my way as to explain the neccessity of qualifying a BMS?'
Once again, thanks for the help.