[R] 21 CFR Part 11 Compliance and R

A.J. Rossini blindglobe at gmail.com
Tue May 24 06:30:38 CEST 2005

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

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).


On 5/23/05, Richard Haney <richard.haney at 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 at duke.edu
> Duke Comprehensive Cancer Center
>         [[alternative HTML version deleted]]
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"Commit early,commit often, and commit in a repository from which we can easily
roll-back your mistakes" (AJR, 4Jan05).

A.J. Rossini
blindglobe at gmail.com

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