Q7A does define critical, and what you will probably find as you’re doing your process validation
or going through your development reports is that there are a lot of variables with different levels
that they will contribute. What EWG tried to address in Documentation and Records, is the critical
steps. For your own process consistency, you will probably keep records of steps in addition to
the critical steps. But, we have not stated that there is a second signature required, for example;
the level of documentation is not the same. You will probably have subsets, such as key
parameters, or significant parameters, or whatever.
