Validation Fundamentals

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.