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Writing & Executing aSoftware ValidationProtocol: Plain and Simple
Writing & Executing aSoftware ValidationProtocol: Plain and Simple
Connecting the Life SciencesaskaboutValidation
The Validation Specialists
Writing & Executing aSoftware ValidationProtocol: Plain and Simple
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.
Writing & Executing a Software Validation Protocol: Plain & Simple
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!
Writing & Executing a Software Validation Protocol: Plain & Simple
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: query@premiervalidation.com
978-1-908084-10-1
Print and bound in the United Kingdom
The Validation Specialists
Writing & Executing a Software Validation Protocol: Plain & Simple
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
Writing & Executing a Software Validation Protocol: Plain & Simple
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
Writing & Executing a Software Validation Protocol: Plain & Simple
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
Writing & Executing a Software Validation Protocol: Plain & Simple
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