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actually it can be a winner. I encountred this at a manufacturing company.
firstly the FDA will let some other body do the approval, say state (or if it's overseas the home country govt.)
after that they show up for their own inspection, maybe leave a few notes, requests (for info - not changes), and once that is done they approve you.
every 3 years or so they come back for an inspection - as long as nothing has changed, as long as documentation is in place, they re-approve.
honey the codewitch wrote:
turnaround time on releases/updates in that scenario is just too much
so that means you don't update or change anything, really just don't change a thing - only fix what is broken (and document that to the volume of an encyclopedia.)
doesn't matter if your system runs on RSTS/E on a PDP 11/23, doesn't matter if the cooling system is a monkey pedaling a stationary bicycle, you change nothing, you upgrade nothing, just write (literally, on paper using a pen, on to SOP forms which also never change) a daily ream of logs and the renewals keep coming.
2 or 3 FDA folks roll up, show them you've done the required, let them walk around and flip through a few binders of logs, let them feed the monkey a bag of [very clean] peanuts, get the other monkey CEO to take them out for lunch - that's it.
after many stupid answers the nice folks at Technet said the only solution is to reinstall my signature. What a surprise!
On a side note, back in the dawn of time, my work responsibility was to configure and run UETP1 on RSTS/E machines as final QA. Since the system disk would get wiped, the System Name, which is printed in the header of every message, was of no real import.
Until of course one enterprising QA person realized the length of that field could be completely filled with the text <drum roll="">: PARITY ERROR
Hilarity followed as the tech vainly tried to find the problem.
Our new manager is putting all kinds of documents and procedures in place.
Ah yes, "paperwork" that nobody cares about and nobody will ever read, most likely so that a checkbox can be checked for the auditors when they come to verify some ISO or similar compliance that some other paper-pushing bureaucrats wrote in some dark windowless government office to justify their own existence.
You want the form for a change request?
Do you have the form for approval to receive a change request?
You'd first need to get the form for the form for approval, of course.
Why, it's forms all the way down!