Episode Details
Back to EpisodesALCOA+ Explained: The 9 Data Integrity Principles FDA Actually Cites
Published 3 days, 6 hours ago
Description
When an FDA investigator stops trusting your data, the inspection is over — because if the records can't be trusted, nothing built on them can be. Marcus and Priya break down all nine ALCOA+ principles — Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available — what investigators actually find when each one is missing, and the Monday-morning fixes that close most findings before they happen.
• The 9 ALCOA+ principles, explained in plain language• What investigators actually check first: audit trails, user access, backups, QA's real role• Why most data integrity 483s are discipline failures, not technology failures• The small-site objection steel-manned: where the money actually matters• The 4 moves a QA manager should make this week
New episodes every Monday and Wednesday — follow The GMP Insider so you never miss one.Connect with Tushar Arora on LinkedIn: https://www.linkedin.com/in/tushar-a-926382161Watch on YouTube: https://www.youtube.com/@TheGMPInsider
Produced with AI assistance.
• The 9 ALCOA+ principles, explained in plain language• What investigators actually check first: audit trails, user access, backups, QA's real role• Why most data integrity 483s are discipline failures, not technology failures• The small-site objection steel-manned: where the money actually matters• The 4 moves a QA manager should make this week
New episodes every Monday and Wednesday — follow The GMP Insider so you never miss one.Connect with Tushar Arora on LinkedIn: https://www.linkedin.com/in/tushar-a-926382161Watch on YouTube: https://www.youtube.com/@TheGMPInsider
Produced with AI assistance.