Re: [R] 21 CFR Part 11 Compliance and R

From: A.J. Rossini <blindglobe_at_gmail.com>
Date: Tue 24 May 2005 - 14:30:38 EST

21 CFR Part 11 is mostly about data audit trails (tracking changes and electronic signatures) and validation of software.

Most of this involves documentation and the creation of documentation LOCALLY at YOUR site, regarding YOUR processes and operating procedures.

R satisfies most of what is needed, depending on who you are. If you happen to be working for a large Pharma, it comes up slightly short, but not too short; I happen to know of 2 pharmas very interested in getting the gaps filled, and an analysis suggests that this is simple, though time consuming, of course. Hopefully, the missing pieces will exist soon (mostly traditional vendor documentation for validation).

If you happen to be working in an nonprofit/academic setting, R is probably fine (again depending on your SOPs, data transport audit trail, etc).

best,
-tony

On 5/23/05, Richard Haney <richard.haney@duke.edu> wrote:
> I have used S-PLUS, R, MATLAB and SAS for many years, and I am actually
> quite happy to use any of these four languages. The reason may in part
> involve my using the various languages for the purposes to which they seem
> most suited. Hence there are many things for which I would not use SAS or
> MATLAB, but for which I would greatly prefer to use R instead.
>
> On the other hand ( to take one of a couple of examples), in the past I
> have not even been permitted to use "R" whatsoever in clinical trials
> applications, which also typically involve a need for CFR Part 11
> compliance. In this context, though, may I ask if there are people who
> have recently been able to use R for clinical trials work that is done
> within an FDA-approved 21 CFR Part 11-compliant framework?
>
> Thanks very much.
>
> Rich Haney
> Richard.Haney@duke.edu
> Duke Comprehensive Cancer Center
>
>
>
>
> [[alternative HTML version deleted]]
>
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-- 
best,
-tony

"Commit early,commit often, and commit in a repository from which we can easily
roll-back your mistakes" (AJR, 4Jan05).

A.J. Rossini
blindglobe@gmail.com

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Received on Tue May 24 14:34:53 2005

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