Hi All,
We need to get clarification from Kristin as to what kinds of issues are raised
in the context of a risk analysis from her IT people.
Since Kristin's wording indicated:
"...all programs that our employees/providers use must be vetted through the
IT Department by way of a Risk
I think the question of validation is very different from the risk analysis
referenced in the subject line.
On the subject of the FDA accepting open source software. Personally I've
done two sBLA submissions where simulation results were essential aspects
of the filings. Both were approved and
Dear all,
any (!) software used in regulated environments has to be validated.
Regrettably is is a misconception by many working in the pharmaceutical
industry that only studies evaluated by SAS are accepted by the FDA.
See this one-pager https://www.fda.gov/media/109552/download and a
No, it was precisely my *point* that Matlab is proprietary.
The medical researchers I knew a few years ago refused to use
R on the grounds that the international agencies they dealt
with all used SAS, which is proprietary. So I am wondering
if "ALL programs that our employees/PROVIDERS use"
Ummm...Except that Matlab is proprietary and for profit, not open source.
Did you perhaps mean Octave?
Bert Gunter
"The trouble with having an open mind is that people keep coming along and
sticking things into it."
-- Opus (aka Berkeley Breathed in his "Bloom County" comic strip )
On Thu, Jun
Just as a matter of curiosity, what are some of the programs
that have already been vetted, what methods were used, and
how long did the vetting take?
As the R guidance points out, R was not designed for
creating or updating medical records, so it should be
treated the same way as say LibreOffice
I work in Pharma and we use R in all the companies I've worked for. They
are really paranoid and it's used in regulated environments as well with
patient data. So there should be something they can do.
Kristin: I can put you in touch with vendors who do our regulated work in R
if you're
On 6/18/20 3:41 PM, John Harrold wrote:
Hello Kristin,
Are you talking about risk analysis from the perspective of software
vulnerabilities?
It appears that is exactly what is being asked. What is not clear is
whether the installation would be offered to persons or groups on the
network
R is open source software that is offered as-is, and many users of R utilize
additional "contributed" packages which are developed and vetted independently
of the R Core members. In addition, it is common for users of R to add minor
functionality in the course of obtaining useful results, which
Hello Kristin,
Are you talking about risk analysis from the perspective of software
vulnerabilities?
John
On Thu, Jun 18, 2020 at 3:21 PM Wait, Kristin wrote:
> HI all,
>
> I am with a NYS major trauma center and all programs that our
> employees/providers use must be vetted through the IT
HI all,
I am with a NYS major trauma center and all programs that our
employees/providers use must be vetted through the IT Department by way of a
Risk Analysis.
Is there someone I would talk to about this?
I scoured your website and could not find a specific person.
Thank you so much
Kristin
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