Validation of Computerized Analytical Systems

Covering the entire validation process, from writing a validation plan through implementation, testing, and installation qualification, to ongoing calibration, performance qualification, and change control, this book provides readers with complete validation details. It discusses international and FDA regulations with numerous practical examples that show readers how to accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards both cost effectively and efficiently. The templates included supply documentation examples and the checklists assure readers that all aspects of their validation are covered in logical sequence.

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.