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Pharmaceutical Computer Systems Validation: Volume 2 - Real Life Case Studies de Guy Wingate

Pharmaceutical Computer Systems Validation: Volume 2 - Real Life Case Studies: Drugs and the Pharmaceutical Sciences

Editat de Guy Wingate
en Limba Engleză Hardback – 23 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: 9781041371151
ISBN-10: 1041371152
Pagini: 514
Ilustrații: 228
Dimensiuni: 178 x 254 mm
Ediția:3
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. List of Contributors. About The Editor. Abbreviations. Chapter 1: Case Study 1: Clinical Systems. Chapter 2: Case Study 2: Computerized Analytical Laboratory Systems. Chapter 3: Case Study 3: Chromatography Data Systems. Chapter 4: Case Study 4: Laboratory Information Management Systems. Chapter 5: Case Study 5: Process Instrumentation. Chapter 6: Case Study 6: Process Control Systems (Operational Technologies: OT). Chapter 7: Case Study 7: Process Analytical Technology. Chapter 8: Case Study 8: Manufacturing Execution Systems and Electronic Batch Records. Chapter 9: Case Study 9: Building Management Systems. Chapter 10: Case Study 10: Spreadsheets. Chapter 11: Case Study 11: Database Applications. Chapter 12: Case Study 12: Electronic Document Management Systems. Chapter 13: Case Study 13: Enterprise Resource Planning Systems. Chapter 14: Case Study 14: Marketing and Supply Applications. Chapter 15: Case Study 15: IT Infrastructure and Associated Services. Chapter 16: Case Study 16: Big Data Management. Chapter 17: Case Study 17: Web-based Applications. Chapter 18: Case Study 18: Blockchain. Chapter 19: Case Study 19: Mobile Devices. Chapter 20: Case Study 20: Medical Devices and Their Automated Manufacture. Chapter 21: Case Study 21: AI-enabled Computerized System. Chapter 22: Case Study 22: Blood Establishment Computer Systems. 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.
• Covers 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 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 US FDA and other regulators.
• Discusses 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 edition of the book is split into two volumes. The first volume provides a comprehensive walk‑through of lifecycle 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 systems, data lakes and digital twins.
This is the second of two volumes making up this book. The first volume is available from the same publisher as a companion to this volume.

Notă biografică

Guy Wingate, Ph.D., was Vice‑President of Compliance and before that Director of 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 Laroratoty Applications, Validating Corporate Computer Systems and previous editions of this book, Pharmaceutical Computer Systems Validation.