Abstract
Historically we relied on blanket validation approaches across our platforms, tools, and applications involved in GxP work. However, this method can stifle innovation, lead to inconsistencies on what is validated, and diverts resources into process rather than product. This talk will explore one application of risk based validation, which is limiting scope to the process data flows through to a GxP insight, and a clear separation of qualified and validated informatics platforms, from study code like a shiny app. By focusing on critical areas that pose the most risk, companies can ensure compliance while optimizing resources. Drawing from insights and trends observed during the R/Pharma Summit, this session aims to challenge current practices and offer practical strategies for implementing a more streamlined, risk-based approach to validation in the pharma tech landscape.
James Black
PhD (Cantab)
James Black. Kiwi | Epidemiologist | Data Scientist | Engineering enthusiast.