Using Six Sigma in a Computer System Validation Project in a GMP environment

Abstract

Computer Systems Validation is a process used to test, validate, and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable, and traceable. This this is done under a very regulated environment. Biopharma industries use computerized systems like DeltaV™, an automation system that simplifies operational complexity. The Delta V™ is an easy-to-use system that simplifies operational complexity and lowers project risk. Six Sigma is a business management strategy used by different industries to improve the quality of products or services produced by the business through the removal of defects and errors. The Six-Sigma methodology is to improve a process with a positive implication on quality of product or, such as this case, a service in the Information Systems Department, to reduce Computer System Validation delays in the IS Department to zero days in a GMP environment. Key terms -- computer system validation, defects, GMP environment, Six Sigma.