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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-06-04
- Length: 13m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-06-04-191-if-its-not-alcoa-it-didnt-happen-the-real-meaning-of-data-integrity
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/191---If-Its-Not-ALCOA--It-Didnt-Happen-The-Real-Meaning-of-Data-Integrity-e33lmed

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-06-04-191-if-its-not-alcoa-it-didnt-happen-the-real-meaning-of-data-integrity#t=0) Introduction: The Foundation of Documentation
- [2:01](https://hardwarepodcasts.com/podcast/lets-combinate/2025-06-04-191-if-its-not-alcoa-it-didnt-happen-the-real-meaning-of-data-integrity#t=121) The Whiteout Ban and Data Integrity
- [2:58](https://hardwarepodcasts.com/podcast/lets-combinate/2025-06-04-191-if-its-not-alcoa-it-didnt-happen-the-real-meaning-of-data-integrity#t=178) ALCOA Principles Explained

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)

## Most relevant to

established companies

## Mentioned

- ALCOA (other)
- ALCOA+ (other)
- MHRA (company)
- FDA (company)
- Bottle of Lies (product)
- Katherine Eban (other)
- Rand Baxi (company)
- ISO 13485 (other)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2025-06-04-191-if-its-not-alcoa-it-didnt-happen-the-real-meaning-of-data-integrity. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.