Orlando Lopez 
Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation [PDF ebook] 

Destek

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.

€42.55
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Dil İngilizce ● Biçim PDF ● Sayfalar 344 ● ISBN 9781351704359 ● Yayımcı Taylor and Francis ● Yayınlanan 2018 ● İndirilebilir 3 kez ● Döviz EUR ● Kimlik 6677496 ● Kopya koruma Adobe DRM
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