E-raamat: Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies

This guide to computer validation presents basic concepts and principles and reviews regulations in the field and their development, then offers case studies examining practical applications of these principles to different types of computer systems used in pharmaceutical and healthcare companies. The role of risk management throughout the life cycle of a computer system is emphasized not only for the benefit of patient/consumer safety but also in terms of cost- effectiveness. Case studies, written by experienced professional practitioners and engineers, include real observations made by the FDA on the various topics discussed, and explore the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Providing insight into practical aspects of computerized systems and their life cycle management, the book will be useful for suppliers, developers, purchasers, and regulators in the pharmaceutical and healthcare industries. Wingate works in global computer validation in the private sector. Annotation ©2004 Book News, Inc., Portland, OR (booknews.com)

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.