Subscribe to read this article in its entirety.

Practical Use of Automated Tools in Computer System Compliance
Author: Jae Burnett

“Computer Validation Forum” discusses topics and issues associated with computer validation in order to provide useful resources for daily work applications. It brings information regarding regulatory requirements for the validation and qualification of computerized systems.

Reader questions, comments, and suggestions are required to fulfill the objective for this column. Case studies illustrating principles submitted by readers are welcome. Please send your comments to column coordinator Sharon Strause at sastrause@aol.com or to journal coordinating editor Susan Haigney at shaigney@advanstar.com.

KEY POINTS
The following key points are discussed in this article:
• This discussion addresses the use of enabling technology in computer system validation (CSV) projects to most efficiently achieve the validated state in a pragmatic cost-effective manner
• Requirements definition management (RDM) and automated testing software are used regularly for the validation and verification of embedded software in the design and development process for medical devices
• GAMP 5 (March 2008) states that automated CSV testing tools can be used to improve test execution efficiency and effectiveness

Subscribe to read this article in its entirety.