some issues about NONMEM
From: "Rombout, Dr. Ferdinand" - Ferdinand.Rombout@grunenthal.de
Subject: [NMusers] some issues about NONMEM
Date: 2/10/2004 10:51 AM
Dear all,
I can do nothing else than fully agree with the remarks about patches.
Recently I lost an email from the discussion group about one patch. Luckely
I remembered seeing this email and could get some information from Globomax.
However my own search in the stored messages did not lead to any finding!!
If I had not read the email, I would not have been aware.
In light of 21CFRpart11 requirements from the FDA this is not acceptable.
Globomax should have the obligation to notify each person having a valid
NONMEM licens about any need for changes and they should do so in writing to
each individual separate (I think we users have that right by having the
yearly license fee). They should also advice users whether revalidation of
systems/previous results are needed.
Regards,
Ferdie Rombout