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Use BPA's All-in-one Guide to Computer System Validation and Risk Management
“This is a huge contribution to the entire software industry. I am astonished with the breadth and depth of the treatment of the complete software cycle and the multi-disciplinary foci: development, validation, risk management…example after example of what, why, how in every part of the trade.”
BPA offers everything a quality systems professional must know in one easy place. This hands-on and beginner-friendly manual walks you through validation of your computer systems from start to finish. Great for QA professionals, IT professionals, and any owner of a system! Order at (408) 366-0848.
The Computer System Risk Management and Validation Life Cycle, 2006 Paton Press, is a hands-on and comprehensive manual for computer system validation. Easily understood by system users, QA and IT professionals, this book simplifies the validation of a wide range of systems through a clear presentation of fundamental principles, and provides specific guidelines on how to save time and money through a risk-based approach. A case study follows the text and illustrates how one company used the RiskVal Life Cycle(SM) to implement and validate a system that meets regulatory requirements. Thirty-three outlines of deliverables, methods, and processes transform jargon into actionable tasks. Deliverables are mapped to FDA and European guidance documents. The author integrates validation, risk management, and system implementation into a single, easy-to-use process called RiskVal. The RiskVal Life Cycle is applicable to all industries where computer systems pose a substantial risk to business continuity, efficiency, and the integrity of high-value data.
Twelve chapters include discussions on:
content…chock-full of practical advice, reference material, and
excellent, practical guide for organizations that must implement a comprehensive
process to manage the full cycle of technology-based projects.”
Computer System Risk Management and Validation Life Cycle
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