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

Let's Combinate - Drugs + Devices

You’ve heard it before: If it’s not documented, it didn’t happen. But in life sciences, documentation isn’t just a formality—it’s the foundation of trust, compliance, and product quality. In this episode, Subhi Saadeh breaks down what documentation actually means by exploring the principles of ALCOA and ALCOA+.Learn where these principles come from, how they’re applied, and why they still matter—even in today's digital systems. From FDA guidances to $500M data scandals, this episode covers what goes wrong when data integrity isn’t taken seriously.⏱️ Timestamps:00:00 – Introduction: Why Documentation Still Matters01:24 – Defining Data Integrity in Regulated Industries03:06 – ALCOA Explained: Attributable, Legible, Contemporaneous, Original, Accurate07:18 – ALCOA Plus: Complete, Consistent, Enduring, Available08:54 – Real-World Examples: From Whiteout to Warning Letters11:00 – Why Old SOPs Can Ruin New Inspections12:21 – Final Thoughts: Documentation Is About Trust, Not Just Compliance🔍 What You’ll Learn:How ALCOA originated in the 1990s FDA frameworkWhy banning whiteout in labs is about more than inkThe difference between original vs. accurate vs. complete dataHow legacy documentation can break inspectionsThe role of tribal knowledge in document managementThe limits of electronic systems without strong governanceWhy AI and searchability are the next frontier for data integrityHow to think about documentation as a system of trust📚 Mentioned Resources:MHRA GxP Data Integrity Guidance (2018)FDA Guidance for Industry: Data Integrity and Compliance with CGMPBottle of Lies by Katherine EbanSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.