Synopsis
The Computer System Risk Management and Validation Life Cycle is the first technical manual to integrate computer system validation, risk management, and system implementation into a single, easy-to-use process. 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. Easily understood by system users and IT professionals, this book explains basic concepts and translates them into how-to deliverables to simplify the tough decisions associated with a wide range of systems and their potential risks of failure. A case study follows the text and illustrates how one company used the RiskVal life cycle to implement and validate a system that meets regulatory standards.
Twelve chapters include discussions on:
* Defining your computer system requirements
* Choosing between vendors to select the best system
* Ensuring that a purchased system meets regulatory requirements
* Identifying and designing solutions to system problems
* Using risk management tools to eliminate defects, improve implementation quality, and minimize failures of major technological investments
* Qualifying the system for use in a production environment
* Using the system in a way that preserves its viability
* Retiring the system
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About the Author
R. Timothy Stein founded Business Performance Associates in 1994, which has consulted with more than eighty companies from eighteen industry segments, particularly the medical device, pharmaceutical, biologics, and diagnostic industries. Stein brings years of software development and system implementation experience to the subject of computer system risk management. He has a bachelor s degree in chemistry and a doctorate in organizational psychology.
"About this title" may belong to another edition of this title.
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The Computer System Risk Management and Validation Life Cycle
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The Computer System Risk Management and Validation Life Cycle
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