Name: Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation (en Inglés)
SKU: 55015514
Price: 874.93 MXN
Availability: InStock
Author: Orlando Lopez
ISBN: 9781032094700

portada Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation (en Inglés)

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation (en Inglés)

Formato

Libro Físico

Editorial

Crc Press

Autor

Orlando Lopez

Idioma

Inglés

N° páginas

344

Encuadernación

Tapa Blanda

ISBN13

9781032094700

N° edición

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation (en Inglés)

Orlando Lopez (Autor) · Crc Press · Tapa Blanda

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Reseña del libro "Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation (en Inglés)"

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.