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Computer
System Validation Overview
Seminar Agenda
(1/2 day Session)
v Introduction
– Session Agenda and Goals
– Validation Introduction - the What & Why
v Validation Process Overview - the How
v Validation Process Details
– Validation Plan Preparation
– Terminology - Qualifications, Test Phases
– Plan Activities
– System Development Assessment
– Test Process
– Installation & Infrastructure Qualification
– Traceability
v Validation Report
v Validation File Documentation
v Maintaining the Validation - Change Management
v Wrap-up
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