Validation Fundamentals

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.