eBook: Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation (DRM EPUB)
 
電子書格式: DRM EPUB
作者: Orlando Lopez 
分類: Economics ,
Public ownership / nationalization ,
Health systems & services ,
Pharmaceutical technology ,
Precision instruments manufacture ,
Object oriented software engineering  
書城編號: 20984139


售價: $429.00

購買後立即進貨, 約需 1-4 天

 
 
製造商: Taylor and Francis
出版日期: 2018/10/02
頁數: 326
ISBN: 9781351704342
 
>> 相關實體書

商品簡介
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.
Orlando Lopez 作者作品表

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