株式会社極東書店トップ ＞ 商品一覧 ＞ Pharmaceutical Computer Systems Validation: Volume 1 - Quality Assurance, Risk Management and Regulatory Compliance. 3rd edition
商品詳細
Pharmaceutical Computer Systems Validation: Volume 1 - Quality Assurance, Risk Management and Regulatory Compliance. 3rd edition
・ISBN 978-1-032-98108-6 hard GB£ 210.00
￥66,528.- (税込) ※（※）価格はご注文時の参考価格となります。
納品価格につきましては書籍の入荷時点で確定となります。
版元の原価改定、外国為替の変動等により異なる場合がございますので、予めご了承下さい。
| 著者・編者 | Wingate, Guy (ed.), |
|---|---|
| シリーズ | (Drugs and the Pharmaceutical Sciences) |
| 出版社 | (CRC Press, UK) |
| 出版年月 | 2026 |
| ページ数 | 490 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A05-16966＞ |
解説
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 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.