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Jason Kraus wrote:

[snip - r.e. source new 21 CFR 11 electronic signature requirements]

> Sure thing:
> 
> http://www.access.gpo.gov/nara/cfr/waisidx_06/21cfr11_06.html - Check
> out 11.200 . The actual wording is
> 
> "Be administered and executed to ensure that attempted use of an
> individual's electronic signature by anyone other than its genuine
> owner requires collaboration of two or more individuals."
> 
> Perhaps I interpreted this wrong? It seems somewhat illogical as
> others have pointed out, there are other kinks in the system that
> could be exploited by one person. I believe the purpose of this
> requirement is such that the administrator can't simply forge
> signatures/documents using the powers given to them.

Perhaps someone ought to ask the FDA just what they're thinking -
perhaps for an example of a system that suffices (and then show them
that it doesn't ?)  If someone's looking over your shoulder as you type
in a userid and password, is that "collaboration of two or more
individuals" ? It might be all they need to use your signature.

David Looney

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