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Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation - Tapa dura

Lopez, Orlando

 
9781138041189: Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
Tapa dura
ISBN 10: 1138041181 ISBN 13: 9781138041189
Editorial: Productivity Press, 2018

Sinopsis

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.

"Sinopsis" puede pertenecer a otra edición de este libro.

Acerca del autor

Orlando López

E-records Integrity SME

Durham North Carolina USA

Orlando Lopez has significant understanding and experience with worldwide regulatory authorities regarding CSV, e-records integrity, and related requirements/guidelines related to Production Manufacturing Systems, IT Systems, Analytics, and Business Intelligence.

He has knowledge and experience in the development of governance and SLC deliverables. Wrote and deployed CSV methodology to computer infrastructure J&J worldwide. Several times he had re-engineered the computer validation methodology to regulated companies.

Orlando Lopez has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications.

He is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation (Taylor & Francis Group, LLC) and had written 25+ publications, including 9 computer compliance related books - amazon.com/author/orlandolopez/

Familiar with gap assessment, remediation planning and remediation execution activities.

"Sobre este título" puede pertenecer a otra edición de este libro.

Editorial
Productivity Press
Año de publicación
2018
Idioma
Inglés
ISBN 10 
1138041181
ISBN 13 
9781138041189
Encuadernación
Tapa dura
Número de edición
1
Número de páginas
326
Contacto del fabricante
Taylor and Francis, GPSR Taylor and Francis
gpsr@taylorandfrancis.com

Taylor & Francis Verlag GmbH, Kaufingerstraße 24
München
80331
Alemania