Re: electronic signatures

["Harris, Michael C." <HarrisMC () HEALTH MISSOURI EDU>]

Hi neighbor,

I think I sent you my e-signature 21 CFR 11 blob of junk, right?  It is
the FDA guideline but is the document most federal grant and other
(state) agencies reference as the standard for electronic signature...
 
There is some ambiguity surrounding 21 CFR 11 regarding the electronic
signature standard it has been re-drafted but not yet approved or
published in the Federal Register. I believe it is possible to satisfy
the intent or best practice by following the security measures of the
"underlying predicate" rules. Interpretation may be somewhat relaxed
from the original according to the 5667 document below as per the
"narrow interpretation" described. Above all have your legal council
review what you come up with.  
 
http://www.fda.gov/cder/guidance/5667fnl.htm  

http://www.fda.gov/cder/guidance/5505dft.pdf 
(draft FDA guidance, not yet approved, general rewrite of above)

generalized 21 CFR 11 documents

http://www.fda.gov/ora/compliance_ref/part11 

http://www.fda.gov/ora/compliance_ref/part11/FRs/background/pt11finr.pdf


Hope that helps. Good luck this is a thorny area
 
Mike

________________________________

From: The EDUCAUSE Security Constituent Group Listserv
[mailto:SECURITY () LISTSERV EDUCAUSE EDU] On Behalf Of Youngquist, Jason
R.
Sent: Thursday, January 15, 2009 3:37 PM
To: SECURITY () LISTSERV EDUCAUSE EDU
Subject: [SECURITY] electronic signatures



We are investigating what we need to do in order to be in compliance
with the E-Sign Act/UETA, so we can start accepting electronic
signatures by students.  For schools that have done this, could you
please tell me how you implemented your solution?  For example, when
generating a student's account, could we also generate a random PIN
which would be their "electronic signature" and send this through email?
[though email is inherently insecure].  Since we have a number of
on-line students all over the globe, the solution needs to be 100%
electronic.  If we sent out a letter through the mail to an on-line
student with their random PIN by the time they received the letter their
on-line course may be well under way .

 

 

Thanks.

Jason Youngquist

Information Technology Security Engineer

Technology Services

Columbia College

1001 Rogers Street, Columbia, MO  65216

(573) 875-7334

jryoungquist () ccis edu

http://www.ccis.edu <http://www.ccis.edu>