That is certainly possible. There are quite a few interested parties
involved and the primary relationship would seem to be between physician and
patient, however, the whole situation seems fairly complex. It would help to
have more information.



_____

From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On
Behalf Of Acosta_Harry
Sent: Tuesday, July 07, 2009 7:50 PM
To: 21cfrpart11@yahoogroups.com
Subject: RE: [21cfrpart11] 21 CFR Part 11 and REMS








Graham, can it be that the FDA is referring to the Part 11 compliance of
a computerized system used to monitor post-marketing REMS and maybe
HIPAA for electronic patient records?

__________________________

Harry Acosta, BsCh, CMQ/OE, CSQE | IS Project Manager | Allergan | 2525
Dupont Drive, T1-3I | Irvine, CA 92612-1599

Office: (714) 246-2707 | Acosta_Harry@ <mailto:Acosta_Harry%40Allergan.com>
Allergan.com

From: 21cfrpart11@ <mailto:21cfrpart11%40yahoogroups.com> yahoogroups.com
[mailto:21cfrpart11@ <mailto:21cfrpart11%40yahoogroups.com> yahoogroups.com]
On Behalf Of Graham Tinsley
Sent: Tuesday, July 07, 2009 8:35 AM
To: 21cfrpart11@ <mailto:21cfrpart11%40yahoogroups.com> yahoogroups.com
Subject: RE: [21cfrpart11] 21 CFR Part 11 and REMS

Unless you are able to provide more specific examples (e.g. what REMS
program, which supporting system?) then from the information you have
provided I would stick with my opinion that the two "programs" are
mutually
exclusive. Part 11 is intended for manufacturers not consumers. Is it
possible that Part 11 offers examples that could be applied to other
computer systems? Yes - but there are probably other (better) examples
of
controls needed for electronic security that could be considered
standards.

Graham

_____

From: 21cfrpart11@ <mailto:21cfrpart11%40yahoogroups.com> yahoogroups.com
<mailto:21cfrpart11%40yahoogroups.com>
[mailto:21cfrpart11@ <mailto:21cfrpart11%40yahoogroups.com> yahoogroups.com
<mailto:21cfrpart11%40yahoogroups.com> ] On
Behalf Of James Spangler
Sent: Sunday, July 05, 2009 5:20 PM
To: 21cfrpart11@ <mailto:21cfrpart11%40yahoogroups.com> yahoogroups.com
<mailto:21cfrpart11%40yahoogroups.com>
Subject: Re: [21cfrpart11] 21 CFR Part 11 and REMS

I understand what you are saying, however, in the FDA appilcations
letters I
have reviewed, none of them mention being 21 CFR Part 11 compliant.
However, in a meeting the other week, someone from the FDA did mention
the
need. As a result, I am trying to pin point something in writing that
spells out exactly how it effects REMS programs and the systems built to
manage these programs. I hope that makes my question a little clearer.

________________________________
From: Graham Tinsley <graham.tinsley@
<mailto:graham.tinsley%40gmail.com>
gmail.com>
To: 21cfrpart11@ <mailto:21cfrpart11%40yahoogroups.com> yahoogroups.com
Sent: Thursday, July 2, 2009 1:48:40 PM
Subject: Re: [21cfrpart11] 21 CFR Part 11 and REMS

One is an apple, the other is an orange?

One is a set of regulations for compliance, specifically covering
electronic
records and signatures. The other is a risk management process
associated
with medication usage. One is intended for manufacturers of drugs, the
other
is intended for patients.

Graham

On Thu, Jul 2, 2009 at 12:43 PM, jspan1971 <jamestspangler@ yahoo.com>
wrote:

>
>
> I am trying to understand exactly what the impact of 21 CFR Part 11 on
REMS
> (Risk Evaluation and Mitigation Strategies) is. I have reviewed
several
REMS
> approval letters and have not seen it mentioned at all. Can someone
provide
> me with more insight?
>
>
>

--
Graham Tinsley
Director, Business Relations
THINQ Compliance Ltd.
+1 613 246 3601
+44 7843 602093

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