similar to: Regulatory Compliance and Validation Issues

Displaying 20 results from an estimated 10000 matches similar to: "Regulatory Compliance and Validation Issues"

2008 Sep 25
0
R Foundation adopts Certification/Validation document
The Board of the R Foundation would like to announce the unanimous adoption of the document entitled: "R: Regulatory Compliance and Validation Issues. A Guidance Document for the Use of R in Regulated Clinical Trial Environments" The updated version of the document, dated August 17, 2008, is available from the main R web page (http://www.r-project.org/) via the Certification link,
2008 Sep 25
0
R Foundation adopts Certification/Validation document
The Board of the R Foundation would like to announce the unanimous adoption of the document entitled: "R: Regulatory Compliance and Validation Issues. A Guidance Document for the Use of R in Regulated Clinical Trial Environments" The updated version of the document, dated August 17, 2008, is available from the main R web page (http://www.r-project.org/) via the Certification link,
2005 May 23
2
21 CFR Part 11 Compliance and R
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
2007 Nov 03
0
R validation. If you know what you want, it's simple. If you don't know what you need to do, there are problems...(with any validation)
> From: delphine.fontaine at genexion.com > To: r-help at stat.math.ethz.ch > Date: Sat, 3 Nov 2007 09:03:39 +0100 (CET) > Subject: [R] R validation > Dear R-Users, > > A message to continue the discussions we had in March and June. I have > read the documents written since then > (http://www.r-project.org/doc/R-FDA.pdf ; >
2011 Jul 21
2
About Validation of R
Dear Sr. of R-project: In the document "R: Regulatory Compliance and Validation Issues. A guidance Document for the Use of R in Regulated Clinical Trial Environments", in the point 6.3 say that exist a set of validation test, that are localized in the test subdirectory. I search the place in the page www.r-project.org and not found this, can you say me where is the set?. I work in a
2009 Jan 11
2
R, clinical trials and the FDA
I hope that Marc doesn't mind, but I felt that part of his recent post was important enough to deserve it's own subject line rather then being lost in a 60-msg-long thread... On Sun, Jan 11, 2009 at 10:08 AM, Marc Schwartz <marc_schwartz at comcast.net> wrote: ... I strongly believe that the comments regarding R and the FDA are overly negative and pessimistic. The hurdles to
2007 Jun 08
6
"R is not a validated software package.."
Dear All, discussing with a statistician of a pharmaceutical company I received this answer about the statistical package that I have planned to use: As R is not a validated software package, we would like to ask if it would rather be possible for you to use SAS, SPSS or another approved statistical software system. Could someone suggest me a 'polite' answer? TIA Giovanni -- dr.
2007 Mar 01
2
Using R for devices trial
I would like to use R for submissions to FDA/CDRH (the medical device company I work for currently uses only SAS). Previous postings to the list regarding R and 21 CFR 11 compliance have been very helpful. However, reluctance to using open source software for statistical analyses and reporting remains high here at my company. Has anyone used R for an official submission to FDA/CDRH? It would
2013 Aug 19
1
[LLVMdev] [cfe-dev] -fsanitize=address on centos 6.4
I did a make update. I thought I was running the newest version of compiler-rt. But now I can't even get the project to build. I get the following error: i386-redhat-linux-gnu-clang++: clang/llvm/include/llvm/ADT/SmallVector.h:544: typename llvm::SmallVectorTemplateBase<T, llvm::isPodLike::value>::iterator llvm::SmallVectorImpl<T>::insert(typename
2013 Aug 19
0
[LLVMdev] [cfe-dev] -fsanitize=address on centos 6.4
+kcc, llvmdev I think your compiler-rt checkout is out of date, because r188635 is supposed to fix that exact issue. On Mon, Aug 19, 2013 at 9:16 PM, Sharma, Yogesh < Yogesh.Sharma at saabsensis.com> wrote: > Sorry about that. I forgot a d:**** > > ** ** > > ldd (GNU libc) 2.12**** > > Copyright (C) 2010 Free Software Foundation, Inc.**** > > This is free
2013 Aug 19
0
[LLVMdev] [cfe-dev] -fsanitize=address on centos 6.4
This looks like the output of "ld --version". What we need is your glibc version, which is given by "ldd --version". On Mon, Aug 19, 2013 at 8:26 PM, Sharma, Yogesh < Yogesh.Sharma at saabsensis.com> wrote: > GNU ld version 2.20.51.0.2-5.36.el6 20100205**** > > Copyright 2009 Free Software Foundation, Inc.**** > > This program is free software; you may
2011 Mar 22
1
how to convert a data.frame to a list of dist objects for individual differences MDS?
I have a 45 x 16 data frame consisting of dissimilarities among 10 colors, giving in each column the 45 = 10*9/2 pairwise judgments for one of 16 subjects. The rownames identify each pair of colors, e.g, "AC" = ("A","C"), and the pairs are ordered by columns in the lower triangle of each distance matrix. > helm.raw <-
2013 Aug 19
2
[LLVMdev] [cfe-dev] -fsanitize=address on centos 6.4
GNU ld version 2.20.51.0.2-5.36.el6 20100205 Copyright 2009 Free Software Foundation, Inc. This program is free software; you may redistribute it under the terms of the GNU General Public License version 3 or (at your option) a later version. This program has absolutely no warranty. From: Kostya Serebryany [mailto:kcc at google.com] Sent: Monday, August 19, 2013 5:36 AM To: Sergey Matveev Cc:
2011 Feb 10
2
for loop to merge .csvs
So I needed to merge 17 .csv files, and did so by brute force, but I might need to do so again. Anyone have suggestions for a for loop that might do the below for me (where a:r are separate .csv files) ab<-merge(a,b,all=TRUE) cd<-merge(c,d,all=TRUE) ef<-merge(e,f,all=TRUE) gh<-merge(g,h,all=TRUE) ij<-merge(i,j,all=TRUE) kl<-merge(k,l,all=TRUE) no<-merge(m,n,all=TRUE)
2013 Aug 19
2
[LLVMdev] [cfe-dev] -fsanitize=address on centos 6.4
+llvmdev (llvm-dev does not exist) On Mon, Aug 19, 2013 at 12:58 PM, Sergey Matveev <earthdok at google.com>wrote: > > First, could you please run the test with env.var. > ASAN_OPTIONS=verbosity=1 > > No need for that, actually, since this is a familiar issue. Sharma, could > you please paste the output of "ldd --version" here? > > Sergey > > >
2013 Sep 17
0
[LLVMdev] LLVM Error
I am running make check and I get the following error: ******************** FAIL: LLVM :: ExecutionEngine/MCJIT/test-ptr-reloc-sm-pic.ll (4965 of 8802) ******************** TEST 'LLVM :: ExecutionEngine/MCJIT/test-ptr-reloc-sm-pic.ll' FAILED ******************** Script: -- /opt/clang+llvm-src/clang+llvm-svncmake/bin/./lli -use-mcjit -O0 -relocation-model=pic -code-model=small
2009 Dec 17
2
SPLUS Seqtrial vs. R Packages for sequential clinical trials designs
Hello Everyone,   I’m a SAS user who has recently become interested in sequential clinical trials designs. I’ve discovered that the SAS based approaches for these designs are either too costly or are “experimental.” So now I’m looking for alternative software. Two programs that seem promising are SPLUS Seqtrial and R.   I recently obtained a 30 day trial for the SPLUS Seqtrial add-on and have
2007 Aug 21
0
Regulatory Computing with R
Dear all - Cody and Bert have some amusing points. The problems with R that Cody states are no different than those that any organization has with any programming work. Period. We've mostly solved them through appropriate approaches, addressing through quality management, some of the issues raised by Cody with respect to 3-rd party packages, etc. Quality Management != Absolute
2006 Mar 29
4
Regulatory Ruling about Caller-ID
Hi, Did anyone hear about a recent ruling which makes it illegal to have caller-id set to anything except what is on the account of the user? IE... If your name is "Joe Smith" you can't have "Mary Smith" set as the caller-id name, unless mary smith is also on your account.
2009 Jan 23
2
The Quality & Accuracy of R
Hi All, We have all had to face skeptical colleagues asking if software made by volunteers could match the quality and accuracy of commercially written software. Thanks to the prompting of a recent R-help thread, I read, "R: Regulatory Compliance and Validation Issues, A Guidance Document for the Use of R in Regulated Clinical Trial Environments (http://www.r-project.org/doc/R-FDA.pdf).