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Validation Fundamentals: How to, What to, When to Validate

Autor William Gibson, Keith Powell-Evans
en Limba Engleză Hardback – 30 apr 1998
Written by the founders of the Institute of Validation, this practical introduction to validation cuts through all the jargon and focuses on the essentials. Whether you are a novice or an experienced validator, this book will help you understand validation fundamentals and ways in which these principles can be bonded with quality assurance, enabling you to build the highest quality into your products. Beginning with definitions of validation, the authors guide you through all the basics, associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects. Packed with tools to help you follow the logic of the validation process, the book covers testing, certification, protocols, final reports, sign-offs, ways to create seamless audit trails, and other topics impacting the qualification of a system, equipment, and/or process.
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Specificații

ISBN-13: 9781574910704
ISBN-10: 1574910701
Pagini: 248
Ilustrații: illustrations
Dimensiuni: 152 x 229 x 20 mm
Greutate: 0.62 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press

Public țintă

Professional

Cuprins

What Is Validation?. History & Roots of Validation. Why Do We Validate & How Much Does It Cost? Who Is Responsible for Validation? How Does Validation Affect You? Validation Policy, Strategy Protocols, & the Validation Report. What Activities Support the Validation Effort? What Are the Consequences of Not Validating? For Whom Are We Validating? Preparing SOPs & the Validation Master Plan. How Do We Plan & Program Validation? Glossary. cGMP & Standards Related to Training & Education.

Descriere

Written by the founders of the Institute of Validation, this introduction to validation cuts through all the jargon and focuses on the essentials. Valuable to novices and experienced validators alike, this book helps readers understand validation fundamentals and how these principles can help build the highest quality into products. The authors address associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects. The book also provides tools that support understanding the logic behind the validation process and covers testing, certification, protocols, final reports, sign-offs, and ways to create seamless audit trails.