Pharmaceutical Computer Systems Validation (Hardcover)

Idioma: inglés

Editorial: Taylor & Francis Ltd, London, 2026

1032981083 / 9781032981086

Librería: Grand Eagle Retail, Bensenville, IL, Estados Unidos de AmericaGrand Eagle Retail

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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 Features Covers governance framework, roles and responsibilities, quality culture, project life cycle, operational compliance, risk management, electronic records/signatures, supplier management, practical troubleshooting, handling regulatory inspections, metrics, and opportunities for performance improvement. Provides a set of 22 new and updated case studies by industry experts, demonstrating how these computer system validation principles are put into practice. Focuses on GxP regulatory requirements covering GCPs, GLPs, GMPs, and GDPscomplete with observations from inspections by the U.S. FDA and other regulators. Discusses industry regulations and guidance, including current thinking of the U.S. FDA on computer software assurance, the latest guidance from the U.S. 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 multiple locations in the US or from the UK, depending on stock availability.

N° de ref. del artículo 9781032981086

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
1032981083
ISBN 13
9781032981086
Edición
3ª Edición

Grand Eagle Retail

Bensenville, IL, Estados Unidos de America

Vendedor de 5 estrellas

Vendedor de AbeBooks desde 12 de octubre de 2005

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