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Validation of Computerized Analytical Systems

Download or Read eBook Validation of Computerized Analytical Systems PDF written by Ludwig Huber and published by CRC Press. This book was released on 2023-04-28 with total page 268 pages. Available in PDF, EPUB and Kindle.
Validation of Computerized Analytical Systems
Author :
Publisher : CRC Press
Total Pages : 268
Release :
ISBN-10 : 9781000948226
ISBN-13 : 1000948226
Rating : 4/5 (26 Downloads)

Book Synopsis Validation of Computerized Analytical Systems by : Ludwig Huber

Book excerpt: 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.


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