Module 12 Presentations

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