At the September 2025 PDA Regulatory Conference held in Washington, DC, two prominent experts on FDA inspections examined why data integrity (DI) failures continue to surface across the product life cycle and what it will take to build more resilient governance systems that prevent them.
The second-day plenary session on ‘Data Integrity at the Next Level’ provided the opportunity for Live Oak Quality Assurance President and former FDA investigator Peter Baker and CDER Office of Compliance (OC) Division of Drug Quality I Director Carmelo Rosa to share their complementary perspectives. The presentations were followed by an extended Q&A, moderated by industry consultant Susan Schniepp.
Baker’s insights were informed by more than a decade of service as an FDA drug investigator and the roles he played as Assistant Country Director for Drugs in the agency’s Beijing and Delhi foreign offices.
He explored how progress on DI has been limited due to companies remaining dependent on outdated tools and checklist thinking rather than designing workflows around risk-based data governance.
Rosa then followed with a discussion of the broader regulatory context. He reviewed the DI findings in FDA warning letters from 2014 through 2025, which underscore how falsified or missing records, weak audit trails, trial testing until acceptable results emerge and superficial investigations remain stubbornly persistent despite years of guidance and remediation efforts.
These recurring failures, Rosa stressed, are linked to deeper weaknesses in firms’ data governance and quality-unit authority and a lack of meaningful oversight of both internal operations and contract manufacturers.
In line with Baker, he made clear that the root causes extend beyond procedural lapses to deeper organizational and cultural deficiencies. “Data integrity is not just a technical compliance issue but a measure of an organization’s culture,” he said, and depends on leadership commitment, accountability, and engagement from executive management through to the manufacturing floor.
During the Q&A that concluded the session, Baker and Rosa provided additional insights on: ● changing the mindset for data integrity ● DI challenges with AI ● why DI problems persist ● the problem with checklist-driven quality ● common excuses for DI failures ● rethinking ALCOA for DI governance, and ● getting leadership on board for quality culture.
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