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This document outlines the scope of activities at the very beginning of process validation and is considered one of the key components of the process validation life-cycle.
As the project progresses, revisions may be required to account for any possible changes in the scope of the validation plan or the project itself.
It should also mention other validation-related elements that apply, such as DQ, IQ, OQ, PQ, PV (Process Verification), etc., including worst-case scenarios and deviations.
