Computer Software Assurance: FDA’s New Approach to Computer System Validation

Synopsis

A draft guidance of Computer Software Assurance (CSA) for Production and Quality System Software has been recently issued by the FDA. This new guidance, together with the second edition of the GAMP 5 guide, have shifted the emphasis away from indiscriminate scripted testing and documentation, towards more critical thinking and a risk based testing strategy. But CSA goes beyond the deployment of a particular methodology for testing strategy. It is more about a way of thinking about the management of computerized system, moving further towards a risk-based approach in all the aspects of their management.
Now that the new recommendations have been established, this practical session will cover the steps companies should take to align themselves optimally with the new CSA approach and take advantage of the opportunity to improve their software implementation and validation processes, spending less time on the mechanical aspects and getting better results.