EMA Clears Up GMP Standards to Preserve Integrity Across Data Lifecycle

The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle.

A Q&A guidance clarifies the risk-based strategies industry can take to safeguard data. The document spells out the basics, explaining the purpose of data integrity and defining the purview of the data lifecycle, while also offering drugmakers a slew of points to consider.

Most of the information addressed in the document summarizes existing guidance, although it does provide some new examples for clarity.