The System Validation Team
should produce a Validation Report that describes:
·
what was done
·
the results obtained
·
any special considerations
regarding the use of the system that were identified during the validation
process
·
whether the procedure as
described in the Validation Protocol was followed, and if not followed then
what was the deviation and why
·
whether or not the acceptance
criteria were met
·
the documentation that was
generated
·
the location of the
documentation generated
·
the retention period for the
documentation
Independent experts may review the results of specific
validation activities and the summary report may incorporate their findings. |