Documentos de Académico
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Documentation
Sangeeta Sardesai
Sanofi-Aventis
Introduction
Site Validation
Master Plan
Validation
Summary Report
why? by whom?
what ? how?
where? when?
Objective
• A concise statement of the tasks to be performed to
allow a complete understanding of the validation
exercise.
DQ = URS + FS + DS
Trained Personnel
Change
Management Validation Review