Introduction ALCOA+ principles remain the foundation of data integrity in GxP environments, providing a structured framework to ensure that data is reliable, consistent, and compliant with regulatory expectations. In 2026, regulators such as the FDA and EMA are placing even greater emphasis on how organizations implement these principles in practice, not just in theory. Companies must demonstrate that their data is attributable, legible, contemporaneous, original, accurate, a

Introduction EMA data integrity expectations in 2026 are becoming increasingly stringent, with regulators placing greater emphasis on data governance, traceability, and system reliability across GxP environments. As regulatory frameworks evolve, companies must move beyond basic compliance and adopt a proactive approach to managing data integrity risks. Organizations that fail to do so are more likely to face inspection findings, delays in approvals, and reputational damage. U