Validation of Computerized Analytical Systems (e-bog) af Huber, Ludwig
Huber, Ludwig (forfatter)

Validation of Computerized Analytical Systems e-bog

359,43 DKK (inkl. moms 449,29 DKK)
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 furn...
E-bog 359,43 DKK
Forfattere Huber, Ludwig (forfatter)
Forlag CRC Press
Udgivet 28 april 2023
Længde 268 sider
Genrer Chemistry
Sprog English
Format epub
Beskyttelse LCP
ISBN 9781000948226
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.