Special Edition

Computer and Software Validation Volume II

Computer and software validation practices are quickly evolving. The urgency of securing data integrity and complying with global regulations has never been greater. This ebook aligns global regulations, best practices and case studies featuring the best of CSV. Topics include maintaining the validated state, use of automated testing tools, validation of manufacturing execution systems and software, the emergence of cloud computing, building software, computer system compliance, requirements management, and integration of risk management.

Table of Contents:

Maintaining the Validated State in Computer Systems
Orlando Lopez

Software Validation: Can an FDA-Regulated Company Use Automated Testing Tools?
Janis Olson

Considerations for Validation of Manufacturing Execution Systems
Chris Wubbolt and John Patterson

Lifecycle Considerations for Device Software
John E. Lincoln

Storm Clouds? Cloud Computing in a Regulated Environment
Robert H. Smith

Building High Quality Software
Robert H. Smith

Computer System Compliance and Quality Planning
Benard T. O'Connor

Validation of Software "In-Product" or "As-Product"
John E. Lincoln

Requirement Management
Orlando Lopez

Integrating Risk Management into Computer System Validation
Timothy Fields

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