CSV - Intermediate

Computer System Validation – Requirements: The Basis for Validation

Whether you’re developing a system from scratch or purchasing a system, requirements need to be defined. That should be obvious if you’re developing software but maybe not so much if you’re purchasing software. Consider buying a pre-built house or condominium. You’re not going to take the first one you walk up to just because it’s available. You’re going to, at least at some level, establish your requirements. In this course we will discuss software in the same manner, what is your intended use for it?

CEU Credits: 0.1

Course Code: ELM-134

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

Learning objectives

Who should I 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 4: Requirements the Basis for Validation

Setting the scene

Requirement basics

Verifiable requirements

Quality considerations with software

Testable or verifiable

Measurable targets

Anomalous conditions

Shall Vs Should Vs Must

Requirement tracing

Requirements for purchased systems

10 best practices for creating user requirements

Conclusion

Final Assessment

Certification

Author

Kevin Martin

Managing Partner at Azzur

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