Validation clearly is a requirement for regulatory compliance. Every indication is that the regulations will focus more and more on electronic generation of data, data control, and data transfer. The goal of this book is to provide guidance for validating commercial, off-the-shelf (COTS) computer software that generates data or controls information about products and processes subject to binding regulations. Drawing upon the authors` extensive 21 CFR Part 11 experience, this book offers a systematic approach to validation, from the determination to validate COTS computer software to assessing the outcome of the process. It also tells what measures companies must take to ensure that systems remain compliant with the binding regulations. Making the transition from manual record keeping to the electronic, paperless arena is not effortless. This book provides practical, step-by-step guidance for validating COTS software in compliance with the FDA`s final rule on electronic records and electronic signatures. Intrinsic in the FDA law is that electronic systems that control the research, development, manufacturing, packaging, and distribution of products undergo validation. Here is the information you need to proceed with confidence.
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