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 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 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 immediately. 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 https://www.stat.math.ethz.ch/mailman/listinfo/r-help