Data governance and catalogue for a pharma manufacturer

The client is a Swiss pharmaceutical manufacturer whose GxP-regulated data had to be traceable and its access controlled. In pharma, inspectors expect a clear answer to where data came from and who can touch it.

That information lived in people's heads and scattered documents rather than anywhere a regulator could actually inspect.

The manufacturer could not show inspectors where its GxP data came from or who was able to touch it. The answers existed informally but not in any inspectable form.

Lineage and ownership lived in people's heads and scattered documents, not anywhere a regulator could inspect. Knowledge that cannot be shown is, for compliance purposes, knowledge that does not exist.

That gap was a genuine compliance exposure on regulated data domains. Closing it was a regulatory necessity, not a nice-to-have.

We stood up a data catalogue with automated lineage, wired directly into the pipelines so the lineage graph stays current as data moves. Capturing lineage from the pipelines is what keeps it accurate rather than aspirational.

Ownership was assigned to every regulated asset, making accountability explicit and inspectable. Clear ownership is what an inspector expects to see.

Because lineage is captured automatically rather than documented by hand, it does not drift out of date, and we prioritised the GxP domains first, where the inspection risk was highest. The highest-risk data was made inspection-ready first.