In brief, 
1) Yes, and many wikis track who made changes. Wikipedia does it with
username OR IP address; internal wikis can be tied into organizational
identity management, Active Directory, etc.; the standards wikis I mentioned
use registration. This one does not appear to do any of those, but that's
somewhat addressable; and again, how many of us have the energy and
inclination to go trash such a narrowly focused apparatus? And FWIW the way
many wikis work is not to change something if it's not directly applicable,
it's to break it out in additional detail, additional (related) articles,
etc. 

2) Absolutely. So those making changes should add their cites - and because
it's a web/wiki-type thing, the users need not be limited to stating the
cite but could actually link to the appropriate place on the local state
listing of statutes, CFR, etc. and those looking could actually review the
cite themselves to judge its pertinence. And yes, there'd be a bunch of
citations, but that's the nice thing about having a full-text searchable,
browsable, wiki-type application: you can do those searches. Again, not sure
this provides that functionality, but it should. 

3) Again, how is this different from a schedule created by any consultant?
The cite is there - and the cite isn't GCR necessarily, it's 21 CFR 11 or
whatever. That GCR is the initial source is immaterial - the ultimate cite
is the actual source. Now, for business requirements, it's a different
issue. Then again, there is no hard requirement for business requirements to
be different from regulatory requirements, nor to store ANY records that are
not covered by regulatory requirements. 

The key in my mind is to identify the applicable requirements, document them
as is, and move on. If you go back to the wiki and the cite has changed,
that should set off a reaction along the lines of "Hrm, the cite has
changed. I wonder why? I better look at the one I created, and the original
cite, and this new cite, and see what happened" - in other words, the same
thing you'd do if you subscribed to IRCH's stuff and the cite changed in the
next version. Nothing any more difficult here than anywhere else, and
arguably slightly easier if the users cite using links because you can go
look at the original rather than simply trusting the cite provided. 

Larry's final point is of course correct and I think the same one many
others made: this has the potential to be a superlative starting point but
would probably not be the best ending point. I still think that
organizations that use ANY of the GCR work would be better off than not
doing anything, and there are still far too many organizations out there
with NOTHING in place. 

Regards, 

Jesse Wilkins
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