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cbrandtbuffalo (4462)

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Perl programmer at the University at Buffalo.
Monday September 08, 2003
08:07 AM

FDA doesn't like Perl?

[ #14579 ]
We're already trying to start some buzz about YAPC here in Buffalo, and a colleague of mine emailed a friend who does Perl to tell him. He responded:

"We use it [perl] extensively now but 21CFR-11 (FDA certification) is probably going to force us away from perl, CGI, etc (and any open source stuff)."

Does anyone know any details about this regulation and why this company would not be able to use open source software? I know there was a session on open source and the US Government at OSCON, but I missed it and couldn't find any on-line slides.

So far, I've found a web site on the actual regulation and there is some info there. From my reading of the August 2003 update from the FDA, they don't plan to exclude any types of software.

If this is a common misconception, then is seems we (supporters of open source) need to help squash it ASAP! If anyone has any info on this, I'd really like to hear about it.
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  • by delegatrix (506) on 2003.09.08 10:39 (#24006) Homepage
    Regulations like this are open to lots of interpretation. I don't see how this reg affects the use of perl. Perl has so many uses, not just CGI. And it seems that if you meet the regs using perl, you're ok. Regs like this generally set a standard but don't specify acceptible methods of reaching the standard. Even regs that set standards for compliance sometimes say "Well, if you can comply some other way, feel free."
    • That was my feeling, but this person seemed pretty convinced it was specific enough to cause a technology shift in their company. I'll have to get some more detail and find out if some serious misconception needs to be de-bunked.
  • So, have you found out yet if Duff's caters?