Data integrity is a core pillar of GMP compliance and a critical responsibility of Quality and Laboratory organizations supporting CMC activities. Regulatory agencies continue to cite data integrity failures as systemic quality breakdowns rather than isolated errors, with a strong emphasis on governance, oversight, and management accountability. This session focuses on how QA/Compliance and Laboratory/CMC functions can strengthen data integrity through effective control and security frameworks aligned with GMP expectations.

The presentation will examine current GMP-focused regulatory frameworks and enforcement trends from FDA, EMA, MHRA, and PIC/S, using inspection observations and warning letter case examples to illustrate regulator expectations and common failure modes. Topics will include data lifecycle mapping in laboratory environments, governance models defining QA and data ownership, access and privilege management, audit trail review strategies, computerized system controls, and the interface between data integrity and cybersecurity. Case studies will highlight deficiencies related to system configuration, shared accounts, incomplete audit trail review, and ineffective QA oversight.

Designed as a practical 2-hour session, this presentation emphasizes translating regulatory expectations into defensible QA and laboratory controls. Attendees will gain clarity on how inspectors assess data integrity maturity, how QA should exercise effective oversight without duplicating laboratory operations, and how risk-based approaches can be used to prioritize remediation and sustain compliance. The session reinforces data integrity as an integral component of pharmaceutical quality systems, inspection readiness, and reliable CMC decision-making.

Key Takeaway Points

• Regulators view data integrity failures as systemic GMP quality failures
• QA is accountable for governance and oversight, not just deviation management
• Laboratory systems are a primary inspection focus for data integrity controls
• Establish clear data ownership and accountability across the laboratory data lifecycle
• Integrate procedural controls, training, and QA oversight into daily laboratory operations
• Audit trail review and access control remain top enforcement drivers
• Risk-based governance is essential for sustainable GMP data integrity

Who Should Attend

• Quality Control
• Quality Assurance
• Regulatory Affairs Professionals
• Manufacturers of raw materials and ingredients
• Pharmaceutical & Compliance Scientists
• Analysts and Laboratory Managers