Comment Re:Some regulated equipment is windows only... (Score 1) 497
Ooooh, lot of different things going on here, I just typed a page of explanation, wondered if it was to esoteric, and then Omniweb crashed and I lost it all. That guidance is for medical device development. Very specific. Very complicated. Also very complicated is how to read a guidance in terms of current enforcement. They are written by lawyers and enforced in a particular manner.
I was limiting my observation to the much simpler case of an IT department suddenly deciding to mandate a switch away from Windows, or leaning that way, or phasing things in... whatever.
When I buy laboratory instruments, they come with a validated piece of software that's validated line by line for that instrument. I have never seen validated piece of lab software validated for anything but windows. It may exist but is very uncommon) The validation process is expensive. If I wanted to sub out linux boxes for my windows machines, I could do it if I validated the software for each instrument. First that would take a few years and cost me about $10 million on about $3 million worth of instruments. Second I would need tech specs for the electronic in the instruments that the vendor is not going to provide. Validation is only possible because vendors spread the cost over all their sales and they don't redo it often. I can't afford to change and I have much greater resources at my disposal than most university professors.
For instance, I have one instrument that was validated by the vendor and only runs on a 10 year old copy of window. The vendor will not upgrade the software because they don't want to revalidate the code. It's expensive. That's why a single user license for excel (non validated) costs $90 and a cheap single user copy of the cheapest validated lab software program costs $5000 even though they may do all the same calculations.
Another aspect of validation that just occurred to me is that once complete it can't be changed, so it may be inherently illegal to distribute the source code for a medical device or lab instrument, because the government would never be able to tell if you were running the validation version or a modified and recompiled version. That is just a thought... I can't think of a case where it has come up.
I largely brought this up because it is a frustrating form of mandated government lock-in, and because it is a reality that the OP will need to consider.