ISBN: 9781032094700 - pharmaceutical and medical devices manufacturing computer systems validation (23 risultati)

Condizione: Very Good. : Este libro proporciona información práctica para ayudar en la validación de sistemas informáticos para sistemas de producción, destacando e integrando eficientemente la regulación mundial en el tema. Se presenta un enfoque práctico para aumentar la eficiencia y garantizar que la validación de los sistemas informáticos se logre correctamente. Es relevante para las operaciones reguladas de dispositivos farmacéuticos y médicos. EAN: 9781032094700 Tipo: Libros Categoría: Tecnología|Salud y Bienestar|Ciencias|Negocios y Economía Título: Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation Autor: Orlando Lopez Editorial: CRC Press Idioma: en Páginas: 344 Formato: tapa blanda.…

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Paperback. Condizione: Brand New. 344 pages. 10.00x7.01x0.67 inches. In Stock.

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Taschenbuch. Condizione: Neu. Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation | Orlando Lopez | Taschenbuch | Einband - flex.(Paperback) | Englisch | 2021 | Productivity Press | EAN 9781032094700 | Verantwortliche Person für die EU: Taylor and Francis, Taylor & Francis Verlag Gmbh, Kaufingerstr 24, 80331 München, gpsr[at]taylorandfrancis[dot]com | Anbieter: preigu.…

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Taschenbuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority's requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions.This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved. 344 pp. Englisch.…

Taschenbuch. Condizione: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority's requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions.This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.…