Data Integrity & Electronic Record Compliance Frameworks
Global trends in external DI scrutiny from agencies and corporate owners
Global Trends in External DI Scrutiny from Agencies and Corporate Owners Global Trends in External DI Scrutiny from Agencies and Corporate Owners In an era characterized by increasing regulatory scrutiny and evolving expectations for data integrity (DI) across the pharmaceutical industry, both regulatory agencies like the US FDA and corporate stakeholders have shifted focus toward external independent assessments. This article delves into key trends in external data integrity audits, governance of findings, and strategic regulatory engagement, with an emphasis on compliance frameworks that align with FDA, EMA, and MHRA standards. Understanding the Importance of Data Integrity Data integrity is a…