Computer and software validation practices are evolving quickly with the emergence of virtual networks, cloud computing, SaaS and social media. The urgency of securing data integrity and complying with global regulations has never been greater. This industry publication aligns current global regulations and best practices delivered by industry experts.
Computer System Validation—Definition and Requirements
Computer System Design
System Design and Control
Robert H. Smith
The Nine Most Common Computer Validation Problems: Identify Frequent Deficiencies to Accelerate Your Validation Projects
Accurately Identifying Your Requirements—Will Any Computer System be Right for You?
Janis V. Olson
Computer Systems Quality and Compliance vs. Software Validation
Computer Systems Change Control
How to “Right-Size” Computer System Validation Based on Criticality and Complexity
Frank Houston and Mark Weinglass
Practical Use of Automated Tools in Computer System Compliance
Selecting and Partnering with a Vendor for a Qualified Software Product
Information Security–A Critical Business Function
Disaster Recovery and Business Continuity
System Definition: Defining the Intended Use for a System
Robert W. Stotz, Ph. D.
Lessons Learned in a Non-Regulated Software Validation Project
Brian Shoemaker, Ph. D.
Computer Validation in the New-Clear Age