Installation Qualification, often abbreviated to IQ, is the set of tests that confirm the software is installed correctly. There are many factors that can be considered for a software installation qualification.

These include:

• Amount of memory available on the processor where the software will run
• Type of processor (e.g., 16 –v- 32 bit) on which the software will run
• Available disk space
• Support applications (including revisions!)
• Operating System patches installed
• Peripherals installed

Client Server

Where the system is client / server based, both need to be addressed.

The client side is often most difficult due to the difficulty of maintaining configuration on individual clients.

Browser Issues

One potential issue with some applications, especially web-based ones, is the browser. If you’re a Firefox user, for example, you’ve probably hit some sites where the pages don’t display correctly and you can only see the full site if you use Internet Explorer.

If this is the case with the software being validated, it may be an indication that EACH client configuration should be confirmed via IQ.

Installation Qualification may verify stated requirements. Where this is the case, the requirements should be traced to the specific test objective(s).

Where commercial products or components are used, the requirements for those products / components need to be well understood and, if not documented elsewhere, documented (and verified) in the IQ. Be especially mindful of client –verses – server components.

The Cloud

Now, what about “the cloud” and other virtual concepts? Admittedly, that’s tough. You have essentially relinquished control over where your application runs or where the data is stored. Does that rule out use of such environments in a regulated environment? Not necessarily, again, it comes back to risk.

If there’s no risk to human life then maybe the solution is viable. If the system maintains records that are required by regulation, it will take considerable justification and verification.

As always, if the decision is made to take this direction, document the rationale for the decision and how any risks are mitigated.