Tag: Gxp

Regulatory violations related to data integrity have prompted stricter oversight from bodies like the FDA and EMA. This has elevated the importance of data integrity principles, leading to the evolution from ALCOA to the more comprehensive **ALCOA++**. This advanced framework ensures that data generated throughout the pharmaceutical lifecycle is reliable, secure, and fully traceable, protecting patient safety and enabling regulatory compliance.

Regulatory bodies like the FDA issue hundreds of warning letters annually for non-compliance, with significant financial penalties. Understanding **what GxP in pharma is** becomes crucial, as it represents the set of guidelines that ensures pharmaceutical products are safe and effective.