Kyle,
All of the CFRs are available for free on the web from the U.S. Government.
Just go to www.access.gpo.gov/nara/cfr <http://www.access.gpo.gov/nara/cfr>
and you can do a search on CFR 21 and the full text will then be available.
Kurt Andrews
Compliance Engineer
Tracewell Systems, Inc.
567 Enterprise Drive
Westerville, Ohio 43081
voice: 614.846.6175
toll free: 800.848.4525
fax: 614.846.7791
http://www.tracewellsystems.com/ <http://www.tracewellsystems.com/>
-----Original Message-----
From: Ehler, Kyle [mailto:keh...@lsil.com]
Sent: Thursday, December 13, 2001 11:02 AM
To: 'PSTC list'
Subject: CFR 21 Sec. 11
Could someone explain to me or point in the right direction
for what CFR 21 Section 11 requirements in a product (such as
a disk storage system) for it to be compliant.
I think this is about records and electronic signature authentication
and has something to do with the FDA (CPG 7153.17). It would seem to be
more of an application feature than a hardware requirement?
We are caught ignorant on this one and I dont have
a copy of the CFR 21, much less CPG 7153.17 (?!).
We have found some info, but our layman understanding doesnt
answer the question of what/how to comply.
Anybody?
Respectfully,
Kyle Ehler
< mailto:kyle.eh...@lsil.com <mailto:kyle.eh...@lsil.com> >
Assistant Design Engineer
LSI Logic Storage Systems Div.
3718 N. Rock Road
U.S.A. Wichita, Kansas 67226
Ph. 316 636 8657
Fax 316 636 8321
