Pharmaceutical Computer Systems Validation (Hardcover)

Idioma: inglés

Editorial: Taylor & Francis Ltd, London, 2026

1041371152 / 9781041371151

Librería: AussieBookSeller, Truganina, VIC, AustraliaAussieBookSeller

Vendedor de 5 estrellas

Vendedor de AbeBooks desde el 22 de junio de 2007

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Envío por EUR 32,88 
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Descripción del artículo del vendedor

Hardcover. Computerized systems play a fundamental role in the development, manufacture and supply of medical treatments. This is the third and thoroughly updated edition of the best-selling book dealing with validation, compliance and software in the pharmaceutical, healthcare and medical device industries. The first volume provides a comprehensive walk-through of lifecycle and development methodologies bringing together technological advances, latest regulatory requirements, inspection findings, and compliance strategies. New chapters have been added on agile development methodologies, data integrity, artificial intelligence and machine learning. The second volume comprises an extensive set of refreshed case studies spanning laboratory, manufacturing and supply chain systems with new contributions on databases, spreadsheets, LIMS, blockchain, mobile devices, AI-enabled systems, big data and digital twins authored by various industry experts.Key FeaturesCovers governance framework, roles and responsibilities, quality culture, project lifecycle, operational compliance, risk management, electronic records/signatures, supplier management, practical troubleshooting, handling regulatory inspections, metrics, and the opportunity for performance improvementProvides a set of 22 new and updated case studies by industry experts, demonstrating how these computer system validation principles are put into practiceFocuses on GxP regulatory requirements covering GCPs, GLPs, GMPs, and GDPscomplete with observations from inspections by the US FDA and other regulatorsDiscusses industry regulations and guidance, including current thinking of the US FDA on computer software assurance, the latest guidance from the US FDA/EU/MHRA on data integrity, and the newly published ISPE GAMP 5 Guide (Second Edition)Shares the practical experience and advice from a group of leading computer validation and compliance international experts This new edition deals with validation, compliance and software in the pharmaceutical, healthcare and medical device industries. The first volume provides a walk-through of lifecycle and development methodologies, and the second volume comprises a set of refreshed case studies spanning laboratory, manufacturing and supply chain systems. This item is printed on demand. Shipping may be from our Sydney, NSW warehouse or from our UK or US warehouse, depending on stock availability. …

N° de ref. del artículo 9781041371151

Título
Pharmaceutical Computer Systems Validation (Hardcover)
Autor
Guy Wingate
Editorial
Taylor & Francis Ltd, London
Año de publicación
2026
Estado
new
Encuadernación
Hardcover
Idioma
inglés
ISBN 10
1041371152
ISBN 13
9781041371151
Edición
3ª Edición

AussieBookSeller

Truganina, VIC, Australia

Vendedor de 5 estrellas

Vendedor de AbeBooks desde el 22 de junio de 2007

Tarifas de envío de Australia a Estados Unidos de America

ArtículoDe 25 a 45 días hábilesDe 8 a 14 días hábiles
Primer artículoEUR 32,88EUR 39,10
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The Nile Group Pty Ltd

42 Apex Drive
Truganina, VIC Australia 3029