Module 12 Presentations

• Per Medicines & Healthcare products Regulatory Agency (MHRA)- ‘GXP’ Data Integrity Guidance covers principles of data integrity (ALCOA) • Aims to promote a risk-based approach to data management that includes data risk, criticality and lifecycle. (ICH-E6) • Data processes (as a lifecycle) to identify data with the greatest GXP impact to determine the most effective and efficient risk-based control for data review and implementation Data Integrity: Key to Public Health Protection

The Organisation for Professionals in Regulatory Affairs