CSV Program Implementation using a Risk Based Approach to align ICH with GAMP5

Abstract

it has been 29 years when Process Validation was created. Since then there has been a lot of creations of different types of validations. During the years there have been a lot of improvements in every validation process. Different kind of process has been created to support validations. Quality is an important factor in any process nowadays. In this project we want to align a Quality Risk Management process like ICH Q9 with GAMP5 Computerized Systems Validation process. A DMAIC problem solving method was used to identify gaps between processes and provide a clear view to resolve the problems.in conclusion the best way to align these processes is to begin with a full risk assessment, risk control and continue with the GAMP5 process. Key Terms - Computer Systems Validation, GAMP5, ICH Q9, Quality Risk Management, Risk Assessment.