30-Day Monitoring Period

I am Validation ae electronic Quality Management System (Category 4 COTS)

We have generated a full set of documentation VP, DS, FS, URS, IQ, OQ, PQ and currently we are looking to move into the 30 Day Monitoring period. Can we proceed to the 30 Day Monitoring Period with 2 minor Exceptions still open. The rationale is that tehse would need to be closed before we draft the Final Summary Report.

Any guidance on this is greatly appreciated.


Is the minor exception will result later on as modification in system ? If answer is No, go ahead with the 30 day monitoring. For Yes case there is no choice.

Happy Reading !