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Software
Re: New forum topic - Open Control
Feb 17, 2002 12:35 pm, by Dale Witman
Text :
cww,
I believe this happened because there were too many systems installed before the FDA really got involved and they had to reach a compromise with the industry. They allow any applications that are mass produced to be installed and only validate the special functions we add for our applications. If a software manufacturer cannot prove an install base (I believe 100 or more) with identical configurations an audit would be done at their facility to confirm they meet FDA control standards. We or the FDA do not want to audit every line of code for these software packages, so we choose accepted packages to minimize our work.
Dale
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Re: New forum topic - Open Control
Feb 20, 2002 2:55 pm, by Michael Griffin
Does that mean 100 systems used in that application, or does it mean 100 systems used anywhere in any application? If the latter (used in any application), then that isn't really very restrictive at all. Virtually any off the shelf product could meet that criteria.
If the former meaning is intended (used in that application), then no system would meet the exempt criteria, as there would always be that first system which must be audited.
The "identical configurations" clause would seem to imply that a major software upgrade (e.g., new OS version) would require re-certification. There could be as much or more difference between successive versions of the same system as there is between alternative systems, so an "upgrade" of a commercial product could not be reasonably exempted until it meets the "100 systems in use" criteria.
I suspect that the criteria you mention is intended to ensure that custom code is audited, and also that new versions of commercial products are avoided until other people have had a chance to find the bugs. Is this the case?
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Michael Griffin
London, Ont. Canada
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Re: New forum topic - Open Control
Feb 19, 2002 11:32 am, by Curt Wuollet
Hi Dale.
I think the DOJ ahould talk to the FDA regarding anticompetitive practices. You can't practically use software that isn't already in place because it's not certified so it's impossible to get the installs to get certified unless you can 100 new customers that want to go through a complete audit in order to use your software. I'll bet Microsoft is involved someplace in that one. That sounds like their peculiar idea of competition. That's like the deal they offered PC manufacturers: You can install whatever you want on a PC as long as you pay for a Windows bundle license. Disagree and you pay full retail or we just don't ever get down the list to your allocation. These kinds of tactics are exactly why we need OSS.
Regards
cww
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