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Connecting the Life Sciences
Equipment Qualification First Edition Copyright 2011 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.
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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 Ltd Web: www.premiervalidation.com Forum: www.askaboutvalidation.com Email: query@premiervalidation.com ISBN 978-1-908084-08-8 Print and bound in the United Kingdom
Table of Contents
The Starting Line Why Should I Read This Book? Learning Objectives Terms Explained Qualification versus Validation What are the Benefits of Equipment Qualification? 1 2 4 5 6 7
Equipment Qualification Process Qualification Planning Risk Based Impact Assessment - Qualification Need Assessment
9 10
13
Qualification Phases User Requirement Specification (URS) Risk Assessment What is FAT/SAT? Equipment Design Qualification (DQ) Equipment Installation qualification (IQ) Equipment Operational Qualification (OQ) Equipment Performance Qualification (PQ) Requalification Change Control REFERENCES
23 24 25 44 45 48 51 55 59 61 65