First of all did you right a URS for this system? How did you come to the point where you choose this vendor to host your QMS?
When you say it does not use Cloud Computing not sure what you mean by this. There are many different flavors of Cloud and when it comes to using a system in a regulated environment you need to be very clear what your requirements are.
Another very important point is have you audited the vendor for their QMS and SDLC plus their hosting environment, is this regulated hosting?
If you would like more info my contact details are below, there are many different aspects that need to be considered here.
a URS has not been complete yet, unfortunately i have just inherited the project and corporate have chosen the vendor. I will be ensuring a URS is put before them and that they will be audited before anything gets signed off.
WRT the “cloud”, our data on this SAAS system will not be stored on a cloud, it will be on a physical server.
i would be interested in hearing your thoughts on this,