If you have a closed and completed validation package, and the system
is in production and you discover something that was missed in
validation document review and has to be clarified. You draft a
clarification memo- can you add this new memo to the closed package
and only update your documentation index? Or should memos of this
type not go back into the validation package, but, in another file
category? Curious as to what other pharmas have done in this
situation. thanks.
LJ
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Linda johnson
linda.johnsonsvu@spcorp.com
Schering-Plough
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