Regulatory Operations in the Digital Age: Optimizing eCTD Workflows with Data Analytics
Keywords:
Artificial Intelligence, Food and Drug Administration, European Medicines Agency, Electronic Common Technical Document (eCTD), Natural Language processor (NLP), Technological Acceptance Model (TAM), Resource-Based View (RBV)Abstract
Optimisation of eCTD has been essential in recent days for strategising the data workflow by data-related strategic measures and strategies of automation and AI implementation through regulatory compliance. The research focused on the growing evolution of automation tools and their role in increasing the effectiveness and accuracy of submission workflow. Different challenges, like the interoperability challenges, cost of implementation, and higher resistance to adoption done digitally, have certainly been explored. Different case studies and statistical data show the growth of the eCTD submission workflow through the incorporation of AI. However, suggested recommendations for the challenges involve regulatory measures, the process of standardisation, cost-effective measures, and programme literacy of AI, which has been essential for the integration to be done seamlessly, and adopting things more broadly.
