[R] Validation of R

Spencer Graves spencer.graves at pdf.com
Thu Apr 17 17:37:24 CEST 2003

	  Just to amplify on one of Bill Pikounis' remarks:  I found bugs with 
S-Plus code roughly 16 months ago.  I fixed them myself for my own use. 
  Legally, my modifications could go no further.  If I took the time to 
try to convince the Insightful developers that the bugs were worth 
fixing, they would consider my fixes of develop their own.  However, 
since I modified their functions, it would have been a violation of 
copyright law for me to distribute my fix any further.  If the bug had 
been in C or Fortran, I would have had to develop a correct replacement 
from scratch.

	  Open source is very different.  If I find a bug, I'm encouraged to 
program a fix and offer it to the world.

Spencer Graves

Pikounis, Bill wrote:
> Hi Rob,
>>We conduct contract virology research for large pharma companies. My
>>question is how do we validate this software? I wonder if anyone else
>>has had the problem and might be able to comment.
> Notwithstanding the disclaimer automatically appended below by my "Big
> Pharma" member IT dept on all my email sends, I have not had this problem,
> or perhaps more accurately, not allowed it to be a problem when work I have
> done in R has made it into drug application filings and responses to FDA and
> European regulatory agencies.
> "Validation" of software is an ill-defined concept, so I am afraid I cannot
> offer anything like a concrete "how-to", not would I be surprised if anyone
> else can.  What I would like to suggest is to (1) ask your vendor companies
> what specifically they are concerned about, (2) benchmark some guidelines on
> how you all or others have "validated" other software.
> If you are looking for extensive documentation on whats/hows/whys of R, it
> already has it.  If you are looking for it to compute the same values as
> "validated" software within realistic numeric accuracy for your procedures,
> that is straightforward to do.  And the ultimate key is that anyone can look
> at the source code and have a high probability to get it to run on any
> reasonably current system, and even many systems not so current. 
> On a visible, continuous (daily), *OPEN* basis, there is ongoing review and
> input from the R user community, as well as all the highest standards of
> software engineering that are met by the R core team and other developers. R
> clearly stands up to rigorous, scholastic scrutiny. In my very grateful
> view, this makes R at least as reliable as commercial vendor software that
> claims "validation" or "compliance", etc., ...and probably, more reliable. 
> Hope that helps.
> Bill
> ----------------------------------------
> Bill Pikounis, Ph.D.
> Biometrics Research Department
> Merck Research Laboratories
> PO Box 2000, MailDrop RY84-16  
> 126 E. Lincoln Avenue
> Rahway, New Jersey 07065-0900
> v_bill_pikounis at merck.com
> Phone: 732 594 3913
> Fax: 732 594 1565
>>-----Original Message-----
>>From: Rob Lambkin [mailto:r.lambkin at retroscreen.com]
>>Sent: Thursday, April 17, 2003 4:51 AM
>>To: r-help at stat.math.ethz.ch
>>Cc: Shobana Balasingam; Seb Bossuyt; Katie Benjamin; Alex Mann
>>Subject: [R] Validation of R
>>Hi All
>>I am really very interested in starting to use R within our company. I
>>particularly like the open source nature of the product. My 
>>company is a
>>medical research company which is part of the University of London.
>>We conduct contract virology research for large pharma companies. My
>>question is how do we validate this software? I wonder if anyone else
>>has had the problem and might be able to comment.
>>Robert Lambkin BSc (Hon's), MRPharmS, PhD
>>Director and General Manager
>>Retroscreen Limited 
>>Retroscreen Virology Limited
>>The Medical Building, Queen Mary, University of London,   327 Mile End
>>Road, London, E1 4NS
>>Tel: 020 7882 7624  Fax: 020 7882 6990
>>(Retroscreen Virology Ltd. Registered in England & Wales No:2326557) 
>>The information contained in this message is confidential and is
>>intended for the addressee(s) only. If you have received this 
>>message in
>>error or there are any problems please notify the originator
>>Unauthorised use, disclosure, copying or alteration of this message is
>>strictly forbidden.
>>Retroscreen Virology Limited will not be liable for any 
>>action taken in
>>reliance on the data contained in this e-mail as it may not have been
>>quality assessed or assured.
>>R-help at stat.math.ethz.ch mailing list
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