Induced from Eric’s conversation with a regulatory-audit practitioner (ex-Google medical device background) at the AI in GxP conference (2026-09-15-1516-gxp-audit-war-room-mock-audits), 2026-09-15.
The inspection is a live demonstration
FDA and EMA GxP inspections usually arrive pre-announced, with a notification and an agenda, and the core check is whether system execution actually supports the SOPs: show me this process. The investigator asks how many users ran process X and whether they ran it identically, backed by proofs, logs, and audit trails. Seniority does not decide who faces the inspector; the SOP names the executor, that operator demonstrates, and a quality lead facilitates.
The war room is a prediction operation
The war-room model pairs the people in the room with back-room subject-matter experts watching a scribe’s live transcription of the inspection. Their job is to predict the investigator’s next path and pre-pull the documentation before it is requested. The operator’s trigger phrase is “let me double check that for you”, which buys the war room time; the one unforgivable move is making anything up. That phrase is Never guess in an inspection; say you will double check.
Mock audits keep the muscle warm
Outside firms staffed by former FDA and EMA auditors run mock audits and certify the results. The quality team owns the schedule, typically at least one mock audit per functional area per year. An organization that does not know whether it runs mock audits, Eric’s open question for Moderna’s clinical development group after this conversation, does not know how it will perform when the real agenda arrives. Documents that exist but were not executed are the inspection form of Assuming humans will follow SOPs is hope, not control. The live demonstration is how GxP documentation builds institutional trust on behalf of patients gets tested, and the citations that follow a failed demonstration are still Human error, not AI failure, drives GxP warning letters.