 This publication 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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