Accelerate the implementation of eTMF Systems with Risk-based Validation

With the transition to SaaS systems, there has been an opportunity to take a more risk based approach to validation and testing, leveraging the validation processes that vendors perform as part of software development processes.  Draft guidance from the FDA on Computer Software Assurance codifies this approach.  This session will review the methodology and things to consider in risk-based validation, to find the sweet spot between 100% requirements testing, and simply accepting the product vendor deliverables.