The availability of a process should be proportionate to the needs. This means that a process which is applied only seldom needs not to have a high availability even if it is a critical process the GxP point of view. The process should only be available if needed. It has to be noted however that a process which is applied often or continuously might be assessed as being more critical a business perspective than it is according to GxP.
Eichmüller: Chapter 16 focuses on the criticality of restoring process support. This leaves room for manoeuvre for GxP-critical processes. But the relevant decisions must be substantiated rationally on the basis of risk assessments.
