Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality assured, and validated. The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture.
The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.
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"Whether you are looking for the missing piece of the jigsaw puzzle for your project or guidance on how to meet the regulations in a practical sense, this information resource (which puts principles into practice) is a good place to start!" - from the foreword by Anthony Trill, Medicines and Healthcare Products Regulatory Agency (MHRA)
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Book Description CRC Press, 2017. Hardback. Book Condition: NEW. 9780849318719 This listing is a new book, a title currently in-print which we order directly and immediately from the publisher. Print on Demand title, produced to the highest standard, and there would be a delay in dispatch of around 10 working days. Bookseller Inventory # HTANDREE0173672
Book Description CRC Press, 2003. Hardcover. Book Condition: New. 1. Bookseller Inventory # DADAX0849318718
Book Description Informa Healthcare, 2003. Hardcover. Book Condition: Brand New. 1st edition. 1016 pages. 10.00x7.00x2.50 inches. In Stock. Bookseller Inventory # __0849318718