Validation of Computerized Analytical Systems
Description:
Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details.
International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.
Best prices to buy, sell, or rent ISBN 9780367401726
Frequently Asked Questions about Validation of Computerized Analytical Systems
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The Validation of Computerized Analytical Systems book is in very low demand now as the rank for the book is 10,472,501 at the moment. A rank of 1,000,000 means the last copy sold approximately a month ago.
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