Re: [R] Regulatory Compliance and Validation Issues

2007-08-20 Thread Cody Hamilton
, 2007 8:50 AM To: Cody Hamilton Cc: r-help@stat.math.ethz.ch Subject: Re: [R] Regulatory Compliance and Validation Issues On Fri, 17 Aug 2007, Cody Hamilton wrote: snip I have a few specific comments/questions that I would like to present to the R help list. snip 2. While the document's scope

Re: [R] Regulatory Compliance and Validation Issues

2007-08-20 Thread Frank E Harrell Jr
] Regulatory Compliance and Validation Issues On Fri, 17 Aug 2007, Cody Hamilton wrote: snip I have a few specific comments/questions that I would like to present to the R help list. snip 2. While the document's scope is limited to base R plus recommended packages, I believe most companies

Re: [R] Regulatory Compliance and Validation Issues

2007-08-20 Thread Bert Gunter
: Monday, August 20, 2007 12:17 PM To: Cody Hamilton Cc: Thomas Lumley; r-help@stat.math.ethz.ch Subject: Re: [R] Regulatory Compliance and Validation Issues Cody Hamilton wrote: Dear Thomas, Thank you for your reply. You are of course quite right - the R Foundation couldn't be responsible

Re: [R] Regulatory Compliance and Validation Issues

2007-08-19 Thread Thomas Lumley
On Fri, 17 Aug 2007, Cody Hamilton wrote: snip I have a few specific comments/questions that I would like to present to the R help list. snip 2. While the document's scope is limited to base R plus recommended packages, I believe most companies will need access to functionalities provided

[R] Regulatory Compliance and Validation Issues

2007-08-18 Thread Cody Hamilton
As I work as a biostatistician in the medical devices industry, I have been very happy to take part in several conversations on this list regarding the use of R in a regulated environment. It was with great interest, therefore, that I read the new guidance document for the use of R in