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Pharmaceutical Computer Systems Validation: Volume 1 - Quality Assurance, Risk Management and Regulatory Compliance de Guy Wingate

Pharmaceutical Computer Systems Validation: Volume 1 - Quality Assurance, Risk Management and Regulatory Compliance: Drugs and the Pharmaceutical Sciences

Editat de Guy Wingate
en Limba Engleză Hardback – 15 iun 2026

Manualul Pharmaceutical Computer Systems Validation, aflat la a treia ediție substanțial revizuită, reprezintă o resursă fundamentală pentru profesioniștii din industriile farmaceutică și a dispozitivelor medicale. Observăm o tranziție clară de la metodele tradiționale de validare către abordări moderne, adaptate la dinamica actuală a dezvoltării software. Subliniem integrarea noilor capitole dedicate metodologiilor agile și inteligenței artificiale, elemente care reflectă maturizarea tehnologică a sectorului. Cartea este organizată riguros în 23 de capitole, urmărind progresia logică a unui proiect: de la managementul organizațional și capturarea cerințelor, la codare, testare și, în final, mentenanță și retragere.

Comparabil cu Validating Pharmaceutical Systems de John Andrews în ceea ce privește rigoarea explicării cerințelor GCP, GLP și GMP, prezentul volum se distinge prin actualizarea masivă pentru era digitală, incluzând ghiduri recente despre integritatea datelor de la FDA, EU și MHRA. Notăm cu interes modul în care editorul Guy Wingate a reușit să echilibreze teoria cu practica prin cele 20 de studii de caz detaliate. Acestea oferă soluții concrete pentru sisteme complexe, de la LIMS la tehnologii blockchain și cloud. Față de lucrarea sa anterioară, Validating Corporate Computer Systems, unde accentul cădea pe sistemele corporative mari precum ERP sau MRP II, această ediție extinde spectrul către dispozitive mobile și sisteme activate de AI, oferind o viziune holistică asupra conformității de reglementare în contextul digitalizării accelerate.

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Specificații

ISBN-13: 9781032981086
ISBN-10: 1032981083
Pagini: 528
Ilustrații: 246
Dimensiuni: 178 x 254 mm
Ediția:3. Auflage
Editura: CRC Press
Colecția CRC Press
Seria Drugs and the Pharmaceutical Sciences

Public țintă

Postgraduate, Professional Practice & Development, Professional Reference, and Undergraduate Advanced

De ce să citești această carte

Această lucrare este esențială pentru specialiștii în asigurarea calității și inginerii de sistem care activează în domenii reglementate. Cititorul câștigă acces la metodologii practice de implementare a ghidului GAMP 5 și strategii de gestionare a inspecțiilor regulatorii. Este un instrument indispensabil pentru alinierea proceselor interne la cele mai noi cerințe globale privind integritatea datelor și validarea software-ului bazat pe inteligență artificială.

Despre autor

Guy Wingate este un expert recunoscut la nivel internațional în domeniul validării sistemelor computerizate și al conformității de reglementare în industria Life Sciences. În calitate de editor și autor, a coordonat numeroase lucrări de referință în seria Drugs and the Pharmaceutical Sciences, fiind o voce influentă în interpretarea ghidurilor ISPE și GAMP. Experiența sa vastă în managementul riscului și auditarea sistemelor informatice se reflectă în abordarea pragmatică a volumelor sale, care servesc drept standard de bune practici pentru companiile farmaceutice globale.

Cuprins

Foreword. Preface. About The Editor. Abbreviations. Chapter 1 Introduction. Chapter 2 Organization and Management. Chapter 3 Lifecycle Methodologies & Supporting Processes. Chapter 4 Prospective Verification and Validation. Chapter 5 Project Initiation and Compliance Determination. Chapter 6 Requirements Capture and Supplier (Vendor) Selection. Chapter 7 Design and Development. Chapter 8 Coding, Configuration, and Build. Chapter 9 Development Testing. Chapter 10 User Qualification and Authorization to Use. Chapter 11 Operation and Maintenance. Chapter 12 Phaseout and Withdrawal. Chapter 13 Data Integrity. Chapter 14 Regulated Electronic Records and Electronic Signatures. Chapter 15 Artificial Intelligence & Machine Learning. Chapter 16 Regulatory Inspections. Chapter 17 Compliance Strategies. Chapter 18 Capabilities, Measures, and Performance. Chapter 19 Practical Troubleshooting. Chapter 20 Concluding Remarks. Glossary. Index

Descriere scurtă

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 and compliance of computer systems and software in the pharmaceutical, healthcare, and medical device industries.
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 GDPs—complete 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 edition of the book is split into two volumes. The first volume provides a comprehensive walk‑through of life cycle and development methodologies, bringing together technological advances, the 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 growing role of cloud computing services and IT tools is also discussed. The second volume comprises an extensive set of refreshed case studies spanning laboratory, manufacturing, and supply chain systems, authored by various industry experts, with new contributions on databases, spreadsheets, blockchain, mobile devices, AI‑enabled data lakes and digital twins.
This is the first of the two volumes that make up this book. The second volume of real-life case studies is available from the same publisher as a companion to this first volume.

Notă biografică

Guy Wingate, PhD, was Vice President & Compliance Officer and before that Director Global Computer Validation at GlaxoSmithKline until his recent retirement. A well‑known speaker on computer validation, he has over 30 years of experience in the pharmaceutical industry. He has been a visiting lecturer at the University of Manchester’s M.Sc. in Pharmaceutical Engineering Advanced Training program and the Dublin Institute of Technology’s accredited M.Sc. in Validation Science program. He is an active member of the ISPE and served as Chair of the GAMP Council for 10 years, which is responsible for the internationally recognized suite of GAMP® Guides on computer compliance. Guy led the teams who produced the original GAMP®5 Guide: A Risk Based Approach to Compliant GxP Computerized Systems and the GAMP® Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures. His extensive list of published work also includes the books Validating Automated Manufacturing and Laboratory Applications, Validating Corporate Computer Systems and previous editions of this book Pharmaceutical Computer Systems Validation.