Pharma IT lives at the intersection of GxP, EMA Annex 11, MDR for combination products, and the EU AI Act. Every change to a computerised system needs a documented rationale, a validated test, and a signed release. The current cost of that is months of paperwork and a team that can't move.
URS, FS, DS, IQ, OQ, PQ — the documents exist, but they exist in Word, in five drafts, in three SharePoints. Every change kicks off a rewrite. The actual change took an afternoon; the paperwork took a quarter.
Annex 11 expects an unbroken chain. Today that chain lives in a binder built the week before the inspection — assembled by hand, with whatever evidence the team can find.
Researchers and engineers use ChatGPT, Copilot, Claude. The EU AI Act is here. Your QA system doesn't know which AI was used for what, on what data, with what oversight. Risk grows quietly.
External vendors deliver code; the validation package is your problem. Their deliverables and your validation lifecycle drift apart, and the gap closes only at audit time — expensively.
A process platform for pharma IT teams under GxP and Annex 11 — where every change to a validated system produces audit-ready evidence as a side effect.
Every requirement points forward to the tests that validate it. Every test points back to the requirement it covers. When something changes, the platform tells you what else needs to move — before a deviation gets raised.
Every decision, every signed release, every role, every dependency — logged at the moment it happens. The binder builds itself. Inspections become exports, not reconstruction projects.
Every AI interaction is scoped to an outcome with a recorded purpose, input, and human review step. You can show which AI did what, on what data, under whose oversight.
If you're tightening computerised system validation under Annex 11, building AI use into a GxP environment, or trying to make vendor deliverables fit your validation lifecycle — we should talk.
or reach out directly at support@expedait.org