Categorised. Assigned. Resolved. Traceable.

Because that is exactly what ICH E6(R3) is pushing toward.

Show me how → See how it works

ONE RECORD

Every deviation, every site, in one place

Vera Deviate deviation register: every deviation by site, severity, status and ageing — One governed log: status, owner, age band of risk, and the path to closure — instead of a dozen Excel files.

Vera Deviate controlled intake: EDC export and paper site logs imported as batches

KNOW WHAT HAPPENED

Capture every deviation, from every source

Import EDC exports and site logs; Vera Deviate auto-detects the source and maps fields by subject. No more reconciling a dozen spreadsheets by hand.

KNOW WHO OWNS IT

Review by role, with a clear owner

A role-based reviewer chain — CRA, Medical Monitor, QA, Sponsor, PI — each with a clear status. Comments and e-signatures captured at every step, configurable per study.

Vera Deviate review panel: CRA, Medical Monitor, QA, Sponsor and PI reviewer chain

Vera Deviate review sign-off with 21 CFR Part 11 e-signature

CLOSE IT

Traceable to closure, inspection-ready

CAPA, trend and escalation tracked to closure, with an append-only audit trail under 21 CFR Part 11 — the evidence an inspector asks for, ready before they ask.

HOW IT WORKS