Pharmaceutical Computer Systems Validation: Volume 2 - Real Life Case Studies
暫譯: 藥品電腦系統驗證：第二卷 - 實際案例研究
Wingate, Guy
- 出版商: CRC
- 出版日期: 2026-06-15
- 售價: $8,020
- 貴賓價: 9.5 折 $7,619
- 語言: 英文
- 頁數: 488
- 裝訂: Hardcover - also called cloth, retail trade, or trade
- ISBN: 1041371152
- ISBN-13: 9781041371151
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相關分類:
Machine Learning、科技科普 Technology
尚未上市，無法訂購
商品描述
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.
商品描述(中文翻譯)
電腦化系統在醫療治療的開發、製造和供應中扮演著基本角色。本書是關於藥品、醫療保健和醫療器械行業中電腦系統和軟體的驗證與合規的暢銷書的第三版，並進行了全面更新。
- 涵蓋治理框架、角色與責任、品質文化、專案生命週期、操作合規、風險管理、電子記錄/簽名、供應商管理、實用故障排除、處理監管檢查、指標以及性能改進的機會。
- 提供22個由行業專家撰寫的新案例研究，展示這些電腦系統驗證原則如何付諸實踐。
- 專注於涵蓋GxP監管要求的GCPs、GLPs、GMPs和GDPs，並附有美國FDA及其他監管機構的檢查觀察。
- 討論行業法規和指導，包括美國FDA對電腦軟體保證的最新思考、美國FDA/EU/MHRA對數據完整性的最新指導，以及新發布的ISPE GAMP 5指南（第二版）。
- 分享一群領先的電腦驗證和合規國際專家的實務經驗和建議。
本書的這一版分為兩卷。第一卷提供了生命週期和開發方法論的全面介紹，整合了技術進步、最新的監管要求、檢查結果和合規策略。新增章節涵蓋敏捷開發方法論、數據完整性、人工智慧和機器學習。還討論了雲計算服務和IT工具日益增長的角色。第二卷包含了一系列更新的案例研究，涵蓋實驗室、製造和供應鏈系統，由各行業專家撰寫，並新增了有關數據庫、電子表格、區塊鏈、移動設備、AI驅動系統、數據湖和數位雙胞胎的貢獻。
這是構成本書的兩卷中的第二卷。第一卷可從同一出版社獲得，作為本卷的伴隨書籍。
作者簡介
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(R) Council for 10 years, which is responsible for the internationally recognized suite of GAMP(R) Guides on computer compliance. Guy led the teams who produced the original GAMP(R)5 Guide: A Risk Based Approach to Compliant GxP Computerized Systems and the GAMP(R) 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.
作者簡介(中文翻譯)
蓋伊·溫蓋特（Guy Wingate），博士，曾擔任葛蘭素史克（GlaxoSmithKline）合規副總裁，並在此之前擔任全球電腦驗證主任，直到最近退休。他是電腦驗證領域的知名演講者，擁有超過30年的製藥行業經驗。他曾擔任曼徹斯特大學藥學工程碩士進階訓練計畫的客座講師，以及都柏林科技大學認證的驗證科學碩士計畫的講師。他是國際製藥工程協會（ISPE）的活躍成員，並擔任GAMP(R)委員會主席長達10年，該委員會負責國際公認的GAMP(R)電腦合規指南系列。蓋伊領導了編寫原始GAMP(R)5指南的團隊：以風險為基礎的合規GxP電腦化系統方法，以及GAMP(R)良好實踐指南：以風險為基礎的合規電子記錄和簽名方法。他的出版作品清單中還包括《驗證自動化製造和實驗室應用》（Validating Automated Manufacturing and Laboratory Applications）、《驗證企業電腦系統》（Validating Corporate Computer Systems）以及本書的前幾版《製藥電腦系統驗證》（Pharmaceutical Computer Systems Validation）。
