Module 12 2019

• 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. – 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