CSV - Intermediate

Computer System Validation (CSV) – Validation Testing Part 1

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. In this course we will focus solely on validation testing and what you should consider when doing your own validation testing projects.

CEU Credits: 0.1

Course Code: ELM-165A

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 8: Validation Testing

Definition of Terms

Historical Approach to Computer System Validation (CSV)

GAMP® 5

IQ, OQ, PQ

Installation Qualification (IQ)

Physical Installation

Home Grown

Operational Qualification (OQ)

GAMP®5

Alarms

Interfaces

Testing Requirements Vs Testing the Implementation

Performance Qualification (PQ)

GAMP®5

Exploratory Testing

Exploratory Testing – Testers Mentality

Exploratory Testing – Example

Black Box, White Box, Gray Box!

Conclusion

Final Assessment

Certification

Author

Kevin Martin

Managing Partner at Azzur

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