191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity

What this episode covers

Host Subhi Saadeh explains the principles of ALCOA and ALCOA+ for data integrity in regulated industries like pharmaceuticals and medical devices. He details the five core ALCOA criteria (Attributable, Legible, Contemporaneous, Original, Accurate) and the four ALCOA+ additions (Complete, Consistent, Enduring, Available). Saadeh illustrates the importance of these standards with examples from Katherine Eban's book Bottle of Lies, the Rand Baxi scandal, and a personal FDA inspection story involving lost legacy SOPs.