Episode notes
This episode delves into the ALCOA+ framework (Attributable, Legible, Contemporaneous, Original, Accurate plus Complete, Consistent, Enduring, and Available) as the bedrock of data integrity within Good Manufacturing Practice (GMP). We explain how each principle guides the creation, maintenance, and review of records, ensuring the reliability and verifiability of every data point. Using real-world examples, we illustrate how implementing ALCOA+ protects critical information, facilitates regulatory compliance, and enhances overall quality management. We also discuss the importance of these principles in maintaining trust and ensuring public health in regulated industries like pharmaceuticals and dietary supplements.
Moreover, the episode explores the practical application of each ALCOA+ principle, from ensuring clear attribution of every dat ...