[NMusers] RE: R for regulatory use

From: Faelens, Ruben (Belgium) <"Faelens,>
Date: Fri, 23 Mar 2018 15:36:01 +0000

Dear Christina,

I would love to learn a bit more about this, and an open discussion on this=
 list is probably the best way.

Could you elaborate how specifically the open source nature of R causes con=
cern?
See the nice documentation from the R project core team at https://www.r-pr=
oject.org/doc/R-FDA.pdf
It seems to me that solid controls are in place, and the self-evaluation of=
 21 CFR part 11 by the R Core team does not result in any cause for concern=
. Perhaps I misinterpret or am too optimistic: Which parts of this self-eva=
luation document would you consider insufficient, or cause for concern?

Also see https://www.r-bloggers.com/r-drug-development-and-the-fda/, https:=
//www.r-bloggers.com/fda-r-ok-for-drug-trials/, and especially presentation=
s/posters from people at FDA: http://user2007.org/program/presentations/sou=
kup.pdf and http://blog.revolutionanalytics.com/downloads/FDA-Janice-Brodsk=
y-UseR-2012.pdf
I am quite allergic to people sowing fear, uncertainty and doubt on open-so=
urce software, especially when commercial off-the-shelf software is held to=
 different standards.

Best regards,
Ruben Faelens

From: owner-nmusers_at_globomaxnm.com [mailto:owner-nmusers_at_globomaxnm.com] On=
 Behalf Of Christina Halliday
Sent: vrijdag 23 maart 2018 15:32
To: nmusers_at_globomaxnm.com
Subject: [NMusers] R for regulatory use

Hi Everyone
As we know R has become the programming language of choice in many industri=
es due to its cutting edge capabilities.
However, R's open source nature can cause concern for heavily regulated ind=
ustries and companies that have strict policies around open source usage.
To overcome these concerns, Mango developed "ValidR". Mango's dedicated Val=
idation team have been supporting ValidR customers for a number of years.
ValidR delivers a controlled and validated version of open source R in line=
 with regulatory guidelines such as FDA 21 CFR part 11.

To find out more about ValidR, join our 30-minute free public webinar on Th=
ursday 19 April.
Register for your place here:

https://www.mango-solutions.com/validr/

Any questions please feel free to contact us at pharma_at_mango-solutions.com<=
mailto:pharma_at_mango-solutions.com>


Kind regards
Christina


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Received on Fri Mar 23 2018 - 11:36:01 EDT

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