However, the perception out there is the "SAS is the accepted software" 
especially for regulatory submission and especially in the US. Thus, I 
think validation usually means "Yeah, but did you use SAS to get the 
answer" , no matter how irrelevant the question is. For a 
non-statistician, or a person doing validation certain software do not 
need validation (Microsoft Word, SAS etc.) certain other , perhaps more so 
for open source, validation is essential.

I do recall a thread last year or so that talked about use of open 
software for regulatory purposes.






"Pikounis, Bill" <v_bill_pikounis@merck.com>
Sent by: r-help-bounces@stat.math.ethz.ch
04/17/2003 08:53 AM

 
        To:     "'Rob Lambkin'" <r.lambkin@retroscreen.com>, r-help@stat.math.ethz.ch
        cc:     Shobana Balasingam <s.balasingam@retroscreen.com>, Seb Bossuyt 
<s.bossuyt@retroscreen.com>, Katie Benjamin <k.benjamin@retroscreen.com>, 
Alex Mann <a.mann@retroscreen.com>
        Subject:        RE: [R] Validation of R


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
USA

v_bill_pikounis@merck.com

Phone: 732 594 3913
Fax: 732 594 1565


> -----Original Message-----
> From: Rob Lambkin [mailto:r.lambkin@retroscreen.com]
> Sent: Thursday, April 17, 2003 4:51 AM
> To: r-help@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.
>
> Thanks
>
> Rob
>
>
> 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
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> message in
> error or there are any problems please notify the originator
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>
> Unauthorised use, disclosure, copying or alteration of this message is
> strictly forbidden.
>
> Retroscreen Virology Limited will not be liable for any
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>
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