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.
William Gibson (1914-2008) was a playwright and author whose many works include Goldas Balcony and Two for the Seesaw. The Miracle Worker, his most famous play, won several Tony Awards, including Best Play, and was made into an Academy Award-winning film starring Anne Bancroft and Patty Duke.