The Association for the Advancement of Medical Instrumentation (AAMI) is now offering a comprehensive, hands-on computer system validation manual called The Computer System Risk Management and Validation Life Cycle. The book is ideal for software engineers, validation staff, and other medical device manufacturing professionals who need an understanding of computer systems.

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

AAMI members receive a $35 discount on the publication. The book is available to AAMI members for $90; the list price is $125. The order code is CSRM. To order the publication, call (877) 249-8226 or visit the Marketplace at http://marketplace.aami.org.