Validation of Computerized Analytical Systems - Tapa dura

Huber, Ludwig

 
9780935184754: Validation of Computerized Analytical Systems
Tapa dura
ISBN 10: 0935184759 ISBN 13: 9780935184754
Editorial: CRC Press, 1995

Sinopsis

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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Acerca del autor

Huber, Ludwig

"Sobre este título" puede pertenecer a otra edición de este libro.

Editorial
CRC Press
Año de publicación
1995
Idioma
Inglés
ISBN 10 
0935184759
ISBN 13 
9780935184754
Encuadernación
Tapa dura
Número de edición
1
Número de páginas
266
Contacto del fabricante
no disponible
Persona responsable
gpsr@libri.de
gpsr@libri.de

Friedensallee 273
Hamburg
22763
Alemania

Otras ediciones populares con el mismo título

9780367401726: Validation of Computerized Analytical Systems

Edición Destacada

ISBN 10:  036740172X ISBN 13:  9780367401726
Editorial: CRC Press, 2019
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