Use BPA's All-in-one Guide to Computer System Validation and Risk Management
“This is a huge contribution to the entire software industry. I am astonished with the breadth and depth of the treatment of the complete software cycle and the multi-disciplinary foci: development, validation, risk management…example after example of what, why, how in every part of the trade.”
–Barrett
C. Craner
Director of quality assurance, Lipid Sciences Inc.
BPA offers everything a quality systems professional must know in one easy place. This hands-on and beginner-friendly manual walks you through validation of your computer systems from start to finish. Great for QA professionals, IT professionals, and any owner of a system! Order at (408) 366-0848.
The Computer System Risk Management and Validation Life Cycle, 2006 Paton Press, 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. A case study follows the text and illustrates how one company used the RiskVal Life Cycle(SM) to implement and validate a system that meets regulatory requirements. 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. 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.
Twelve chapters include discussions on:
- Defining 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
“Great
content…chock-full of practical advice, reference material, and
templates.”
–Richard N. Love
Senior director of quality systems, Connetics Corp.
“An
excellent, practical guide for organizations that must implement a comprehensive
process to manage the full cycle of technology-based projects.”
–Dave Kamath
CIO, IDEX Corp.
The
Computer System Risk Management and Validation Life Cycle
Paton Professional LLC
www.patonprofessional.com
$99.95
ISBN 10: 1-932828-09-5
ISBN 13: 978-1-932828-09-2
Contact
Us
Call Tim Stein at 408-366-0848
