Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation (Hardcover)

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.

General

Imprint:	Crc Press
Country of origin:	United Kingdom
Release date:	October 2018
First published:	2019
Authors:	Orlando Lopez
Dimensions:	254 x 178 x 27mm (L x W x T)
Format:	Hardcover
Pages:	326
ISBN-13:	978-1-138-04118-9
Categories:	Books > Computing & IT > Computer programming > Software engineering Books > Computing & IT > Computer programming > Object-oriented programming (OOP) Books > Medicine > General issues > Health systems & services > General Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Other manufacturing technologies > Precision instruments manufacture > General
LSN:	1-138-04118-1
Barcode:	9781138041189

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