RE: R for regulatory use
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 concern?
See the nice documentation from the R project core team at
https://www.r-project.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-evaluation 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
presentations/posters from people at FDA:
http://user2007.org/program/presentations/soukup.pdf and
http://blog.revolutionanalytics.com/downloads/FDA-Janice-Brodsky-UseR-2012.pdf
I am quite allergic to people sowing fear, uncertainty and doubt on open-source
software, especially when commercial off-the-shelf software is held to
different standards.
Best regards,
Ruben Faelens
Quoted reply history
From: [email protected] [mailto:[email protected]] On
Behalf Of Christina Halliday
Sent: vrijdag 23 maart 2018 15:32
To: [email protected]
Subject: [NMusers] R for regulatory use
Hi Everyone
As we know R has become the programming language of choice in many industries
due to its cutting edge capabilities.
However, R's open source nature can cause concern for heavily regulated
industries and companies that have strict policies around open source usage.
To overcome these concerns, Mango developed "ValidR". Mango's dedicated
Validation 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
Thursday 19 April.
Register for your place here:
https://www.mango-solutions.com/validr/
Any questions please feel free to contact us at
[email protected]<mailto:[email protected]>
Kind regards
Christina
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