Data Quality and Integrity in Bioproduction: Principles and practical cases

This activity defines the key concepts and principles related to data integrity in a bioproduction environment and highlights its essential role in ensuring quality, traceability, and regulatory compliance throughout operations.

This activity reviews the ALCOA++ principles to ensure data compliance in bioproduction, exploring the challenges related to handwritten and electronic data. It presents real-life data integrity breaches and assesses their impact on data reliability and compliance with regulatory requirements.

This activity presents examples of breaches of the ALCOA++ principles (handwritten and electronic data) and analyzes their consequences on data reliability and compliance with regulatory requirements.