R in the Cloud: A Holistic Approach towards GxP Compliance


As more and more companies move their compute environments into the cloud, the steps needed to ensure that their software suite and newfound infrastructure are FDA compliant change accordingly. In this talk, we will examine the requirements for an FDA validated architecture in the context of R. This is a potentially tricky process depending on what the user requirements are and since R is open-source, extra care must be taken to ensure validation and qualification of the entire cloud R ecosystem. What does validation and qualification entail, and what are the pitfalls that stakeholders need to be mindful of? This presentation will demonstrate at a high level the steps required to be FDA compliant for a validated R GxP system in the cloud.

Presented at 2022 Conference