Kamesh Raghavendra

Clinical Trial Data is undergoing a renaissance with new insights and data sources being added daily. The speed of new innovations and modalities that are found within trials poses an existential dilemma for 21CFR Part 11 compliance. In these validated environments, new components and methods need to be tested for reproducibility and restricted data access. In classical systems, this validation process would often have taken three months or more due to the manual validation process via validation scripts like Installation Qualification (IQ) and Operational Qualification (OQ) scripts. In conjunction with Databricks, Purgo AI has developed a new technology leveraging generative AI to automate the execution of IQ and OQ scripts and has drastically reduced the amount of time for validating Databricks from three months to less than a day. This drastic speedup of validation will enable the continuous flow of new ideas and implementations for clinical trials.