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Writing & Executing aSoftware ValidationProtocol: Plain and Simple


Connecting the Life SciencesaskaboutValidation

The Validation Specialists


Published by Premier Validation

Writing & Executing a Software Validation Protocol: Plain & Simple

Writing and Executing a Software Validation Protocol: Plain and SimpleFirst Edition

© Copyright 2013 Premier Validation

All rights reserved. No part of the content or the design of this book maybe reproduced or transmitted in any form or by any means without the express written permission of Premier Validation.

The advice and guidelines in this book are based on the experience of the authors, after more than a decade within the Life Science industry, and as such is either a direct reflection of the “predicate rules” (the legislation governing the industry) or are best practices used within the industry.

The author takes no responsibility for how this advice is implemented.

Visit Premier Validation on the web at www.premiervalidation.com or visit our forum at www.askaboutvalidation.com.


So what’s this book all about?

Hey there,

If you've decided to invest some time in reading this book, I am making

the assumption that you are pretty tired of wading through scientific white

papers and 500 page books designed primarily to sell services or more

books!

This quick and easy guide describes methods and approaches for

writing a validation protocol that can help ensure a thorough validation

effort. It also provides some tips and tricks on executing the protocol and

documenting the results.

While this book was written primarily for those new to validation

projects and the effort required gathering sufficient evidence to support

validation claims, experienced folks will likely find nuggets to help improve

their efforts.

Enjoy!


The brains behind the operation!

Program Director: Graham O'KeeffeContent Author: Don HurdTechnical Editor: Alan Smith, Graham O'Keeffe, Peter Jacobs, Irene Kaas.Editor: Anne-Marie SmithPrinting History: Edition: Feb 2013Cover and Graphic Design: Those Concepts

Notes of Rights

All rights reserved. No part of this book may be reproduced, stored in a

retrieval system, or transmitted in any form or by any means, without the prior

written permission of the copyright holder, except in the case of brief quotations

embedded in critical articles or reviews.

Notes of Liability

The author and publisher have made every effort to ensure the accuracy of

the information herein. However, the information contained in this book is sold

without warranty, either express or implied. Neither the authors and Premier

Validation Ltd, nor its dealers or distributors will be held liable for any damages

to be caused either directly or indirectly by the instructions contained in this

book.

Published by Premier Validation LtdWeb: www.premiervalidation.com

Forum: www.askaboutvalidation.comEmail: [email protected]

978-1-908084-10-1

Print and bound in the United Kingdom

The Validation Specialists


Table of ContentsSo what's this book all about? 0

Introduction 1

Scope 6

Product Software 9

Home Grown Software 9

Purchased Software 9

Hybrid Systems 10

Documentation Infrastructure 6

Validation Master Plan 11

(Element) Validation Plan 11

Product Verification and Validation Plan 12

Requirements 12

Risk Analysis 12

Get Organized 6

Ensure a Solid Foundation 13

Product Software 13

Home Grown Software 13

Purchased Software 13

Hybrid Systems 13

Organize Requirements 14


Protocol Development 6

Define Test Objectives 14

Trace Requirements to Test Objectives 14

Organize the Protocols 15

Conceptualize the Test 15

Set Up the Test 15

Write the Test Steps 15

A Few More Details 15

How much is Enough? 15

Preparing for and Executing the Protocols 17

Preparing 18

Identifying Test Personnel 18

Gathering Test Equipment 20

Executing the Protocols in a Controlled Environment 20

Recording Results 39

The Basics 41

Annotations 41

The “Happy Path” 41

Deviant Behavior 42

Variances 44

Handling Attachments 44


Closing Thoughts: Improving 39

Appendix – Test Development Considerations 39

Test Case Development 45

Appendix – Considering Precision 46

Appendix – Protocol Types 39

Formal Protocols 47

IQ 48

OQ 48

PQ 50

Other Protocol Formats 53

Static Analysis 54

Unit-level Test 54

Dynamic Analysis 55

Ad-Hoc or Exploratory Testing 56

Misuse Testing 58

Quiz 62


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