SQA in the medical field - Differences between WinXP Pro and WinXP Home

[rstrina]

I have been a software tester for 5 years, although I have no epxerience with automated testing. I have just recently swiched fields and am now testing a medical product software.

My question to all would be this:
Creating virgin images for the most common operating systems in order to test the software, what are the differences between WinXP Pro and WinXP Home and why would one want to test any software application in either OS?

Have another question as well:
What would speak against using Virtual PC (VM) to test these operating systems? The medical software in question does test hardware connections (in other words) it uses hardware in conjunction with the software!Since I'm working in the medical field, I have to deal with the FDA. The FDA requires to validate any software that is implemented developing or testing the software in question.

Who has had any experience with implementing Quality Assurance in the medical field, in which the FDA requires to see verfication and validation of any development process.

Does anyone know to what extend, VM (Virtual PC) has been validated? How can one validate that testing software on a virtual machine is the SAME as testing it on a virgin operating system?

Anyone who could provide me with some pointers regarding my questions - Replys will be appreciated!

Sincerely, Renate Strina

[Al Rosen]

Hi Renate, Welcome to the Cove.

We use software in our Medical Devices, but I have not had exposure to the systems you mentioned. I will suggest that if you haven't, look at these FDA guidance documents regarding software.

General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Guidance for Off-the-Shelf Software Use in Medical Devices

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

[Marc]

Thanks for the links, Al!