Computer Systems Validation in the 21st Century

Computer Systems Validation continues to evolve as the industry gains better experience and tools with validating the computer systems used in clinical trials and product safety. This session will discuss some of the latest trends in computer system validation, including risk based approaches and the application of validation to the lifecycle of clinical and safety data systems. Case studies will be reviewed that cover the validation of off-the-shelf, home-grown and outsourced data management systems. A Question and Answer session at the end of the session will allow attendees to ask for advice on specific scenarios relevant to their company's validation needs.