21 CFR Part 11 Compliance and R
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 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
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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 at gmail.com