Reg-output fromthe system


Wish You happy new year every body

We are generating reports from the created data base. These reports are just request run. These reports output will not be captuered at any data base. Just system will pick up the data and submit the report in the required format. Whenever user wants the report then system will generate the same report without any deviation. There is no print control copy.

How can we justify these outputs for part 11 compliance.


First off, what predicate rule are you fulfilling with … the report (?)?