Data Tables in Validation Report

Hi All,

I’m just curious how stringent are the rules regarding the data tables that are generally pre-designed in the validation protocol. My question is, can we modify these tables (i.e add in additional column, remove rows, etc) when we use or report them in our validation report?

Thanks in advance for your time and effort.

It depends what you remove from the report by deleting a row or column. It is not allowed to delete any unwanted results, like non-conforming results or results of test failure, where the test was repeated. All deviations from protocol execution and excursions from acceptance criteria have to be reported and justified.
What is allowed e.g. is to report derived data only and refer to the the protocol for the source data. E.g. if two values (columns) are substituted to get the result that is being verified with the acceptance criteria, you may report the substituted value only.

Adding columns is no problem as long as the source of the data is clear.

The column that I would like to add to the table is for reporting the mean (average). The table in the protocol was set up for reporting only the individual results of the replicates that were tested. So I just wanted to know if it’s okay to modify the existing table so that I can include the mean of those individual results. Thanks.