The Computer System Risk Management and Validation Life Cycle 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. 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.
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
Expert Advice
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.
| Details |
 |
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| Weight |
3.00 lbs |
| ISBN: |
1-932828-09-5 |
| Pages: |
608 (softcover) |
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