Last month, the EMA’s Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group published their answers to 23 frequently asked questions related to Data Integrity and the Data Life Cycle.
EMA’s Recommendations
This Q&A document provides insight in the EU regulators’ expectations regarding data risk assessment and mitigation; data security, protection, and retention; electronic signatures; electronic data review; and, ensuring that data integrity standards are met by suppliers and service providers.
Download the entire Q&A session here: EMA Data Integrity for GMP and GDP Q&A
Do you need more help understanding how these topics might affect your organization? Talk to our CSV experts about how you can ensure your processes meet the EMA’s standards.