CSV - Intermediate

Computer System Validation – Validation Master Plan

This course is geared specifically towards those individuals that will perform computer system validation. A certain understanding of software is important to be proficient in CSV but we’ve tried to provide sufficient information for folks with non-software backgrounds to jump into the CSV fray. Those in management positions with responsibility for validating computer systems should also find great benefit in this course. In this module we will concentrate on the Master Validation Plan (MVP) and explain how this is such an important aspect of the entire CSV lifecycle.

CEU Credits: 0.1

Course Code: ELM-163

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

Learning Objectives

Who Should Take This Course?

Course Modules

Module 1: Background

Where is Software Used?

Validation is More than Testing

Scope of this Course

Why Validate – Part 1

Why Validate – Part 2

Hope Through Validation

Regulations, Standards and Guidance

Module 6: Setting the Foundation for a Risk Based Approach – The MVP

Solid Foundation

Roles, Responsibility and Authority

Description of the Facility

Implementing the Risk Based Approach

Patient and GxP Impact

Risk Matrix

Computer System Types

Why is Categorization Important?

Infrastructure

Non-Configured

Configured – IQ

Configured – OQ

Custom

Governance

Configuration Management

Starting and Stopping

Plan for the Unexpected - Test Failure

Plan for the Unexpected – Protocol Issues

Plan for the Unexpected – Expected Results

Approaches

Prospective Validation

Retrospective Validation

Inventory and Classification

Maintaining the Validated State

Conclusion

Final Assessment

Certification

Author

Kevin Martin

Managing Partner at Azzur

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