A document recording meeting notes for
URIT-1200/URIT-1000Plus dated Dec 12, 2012 was provied as an example design
control record.This document discusses issues and associated design
changes(e.g. revision to system rinse time).However,this record does not provide
specific references to design control documents or other controlled documents
which will be impacted,nor the required verification or validation activities.
It is recommended that sufficient detail and references be added to such
records for traceability (e.g. reference to the specific procedure(s) that will
be updated) and clarity of the extent and status of the associated action
items.
URIT-1200/URIT-1000Plus dated Dec 12, 2012 was provied as an example design
control record.This document discusses issues and associated design
changes(e.g. revision to system rinse time).However,this record does not provide
specific references to design control documents or other controlled documents
which will be impacted,nor the required verification or validation activities.
It is recommended that sufficient detail and references be added to such
records for traceability (e.g. reference to the specific procedure(s) that will
be updated) and clarity of the extent and status of the associated action
items.
