Module 12 2019

Per EMA Data Integrity Guidance (2016) – Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities. – Fundamental requirement of the pharmaceutical quality system described in EU GMP chapter 1 – Applying equally to manual (paper) and electronic systems. – “The effort and resource assigned to data integrity measures should be commensurate with the risk to product quality ( risk mitigation ) Data Integrity: Key to Public Health Protection

The Organisation for Professionals in Regulatory Affairs