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.
Table of Contents
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?
cGMP & Standards Related to Training & Education