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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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