The Computer System Risk Management and Validation Life Cycle simplifies the validation of a wide range of systems through a presentation of fundamental principles and provides specific guidelines on how to save time and money through a risk-based approach.

The manual integrates validation, risk management, and system implementation into a single, easy-to-use process called “RiskVal” — a system applicable to all industries in which computer systems can pose a substantial risk to business continuity, efficiency, and the integrity of high-value data. 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.

Author R. Timothy Stein has consulted with more than 80 companies from 18 industry segments, including the medical device industry. The book includes 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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The Computer System Risk Management and Validation Life Cycle	CSRM	$90	$125

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