PharmTech:How can technology be used to prepare and perform CAPAs? In investigating deficiencies, and/or developing action plans?

Elton (ConcertAI): Technology and AI [artificial intelligence] can, and should, be used to create and maintain effective CAPA plans, in clinical trials, real-world evidence (RWE), and medical devices ecosystem. In FDA’s three draft guidance documents published at the close of 2021 on the use of RWE, a number of key technical characteristics were noted as foundation. Upon integration of those across all technical environments interacting with study data, technologies can allow a study dataset to be considered a ‘package’ of data that includes details on its source, source relevance, reliability, etc. These same technologies also allow surveillance of data for anomalies and errors can assemble data to a specified cohort and create registries and comparative data sets assuring consistency with the study plan and any preliminary analyses…