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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