What aspects of the cleanroom environmental monitoring workflow must be validated?

Исследователь смотрит на пробирку с жидкостью

To comply with FDA requirements during review of submissions, each facet of your monitoring workflow should be validated within the context of the overall workflow. For example, if your cleanroom has controlled access, the access control must be validated. So too must the particle counter, your method for recording and storing the reported particle counts and related data retrieval and security plans.