Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healt
Product Description
Both pervasive and ubiquitous, computerized systems are now an vital component of every corporate strategy in pharmaceutical and healthcare companies. But, when technology is combined with high-risk broadcast safety projects or the production and control of life-saving medicines or devices, it is necessary to make sure that it is reliable, quality balanced, and validated. The most comprehensive guide on computer validation now available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the huge picture.The author reviews set of laws and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic minutes and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents matter-of-fact 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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