Pharmaceutical and Medical Devices Production Systems and Quality Control Computer Systems Validation
商品資訊
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. Compliance is a state of being in accordance with established guidelines or specifications.
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 are correctly achieved.
作者簡介
Orlando Lopez
Data Integrity SME
Durham North Carolina USA
Orlando has worldwide pharmaceutical experience with relevant work in computer systems regulatory requirements including US, EMA, Australian, Japanese, WHO, PIC/S, and ICH regulations and guidance's.
Experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications.
He is a member of the data integrity (DI) Working Group (IVT), DI in Manufacturing System Track (PDA) and the Institute of Validation Technology Editorial Advisory Board.
He is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation (Taylor & Francis Group, LLC).
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