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 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.
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
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