Computer System Validation
OVERVIEW According to the FDA requirements all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Computersystem validation is more than testing. It is testing plus design control and configuration management. How to plan and conduct a risk based validation will be explained. Overall risk for computer system is a combination of software complexity and product risk as determined by probability, severity and detectability rankings. Also involved in the risk evaluation is the requirement for purchased software supplier qualification. In this computer system validation training you’ll learn how to integrate risk based supplier evaluation into the computer system validation process. Validation Master plan and System Validation Plans will be explained. Testing, based on risk, includes requirements validation and IQ, OQ and PQ. A procedure for e...