ALCOA … we all know the drill - don’t we?

In busy pharma labs, the process steps become so familiar they slip into muscle memory ... and that’s exactly when those little “quick fixes” creep in and quietly undermine the controls we rely on to stay GxP‑compliant.

I wouldn’t claim to be an eminent authority on Data Integrity, but within GxP laboratory practice I’m comfortable calling myself a well‑grounded, field‑tested practitioner. Based on years of lab experience, I've created this short video on attributable data - showing just how quickly integrity starts to unravel the moment attribution slips.

And let’s be honest: Data Integrity training modules aren’t exactly binge-worthy.  That’s why I use scenarios and analogies to make it feel a bit more 'everyday life' and a bit less like 'mandatory training'. If you’re curious how this scenario ends, stay to the end for the link to the full video.

DI - Attributable (taster video)

FDA inspection data from 2024 showed that incomplete and/or missing records remained a perennial issue — a trend that continued into 2025/26. In fact, 2026 has already seen multiple FDA Warning Letters citing a lack of attributable data among other concerns.

Attributable data is fundamental to data integrity because every action must be traceable to a specific individual, at a specific moment. When attribution is intact, the data stands on its own without relying on memory or assumptions.

The integrity of data often weakens through small, familiar missteps: shortcuts, un‑proceduralised adjustments, process‑creep. Each one introduces uncertainty - and once uncertainty enters the record, validity begins to erode.

Attribution keeps the data lifecycle complete, transparent, and reconstructable from start to finish. When every entry has a clear origin and the supporting metadata is intact, the record becomes self‑evident. It tells a continuous story with no ambiguous ownership and no reliance on guesswork!