Enhancing Regulatory Audit Readiness through Automated Data Lineage and Impact Analysis Using Azure Purview and SAP HANA

Abstract

Data integrity is critical in Good Automated Manufacturing Practice (GxP) environments. This paper explores a cloud-based, automated data governance solution using Azure Purview and SAP HANA to enhance regulatory audit readiness. The proposed architecture automatically classifies metadata, tracks end-to-end data lineage, and visualizes access logs across regulated workflows in real time. It supports compliance with FDA 21 CFR Part 11, ISO 13485, and EU MDR, enabling faster, more transparent, and reliable audit responses while reducing manual overhead and human error.