Hi all. Not totally a 21 CFR question, but somehow closely related.
Is it normal for an electronic document management software provider to
ask for a copy of our database (which means all our official QMS and
validation documents) in order to upgrade us to a newer version of
As QA my first answer is “not a chance”, those documents are
proprietary. I would rather have such consultants over to our place
and analyse the database at our premises, or even remotely. The
copying is a little hard to justify IMO. I wanted to have other
opinions on this, if possible. Any comments are appreciated.
Thanks a lot!