You're past science risk — now it's execution risk. Istari's Validated tier gives you controlled documents, white-label regulatory output, version-locked exports, and tamper-evident audit trails — the framework that holds up when the stakes are highest.
Drafting got you here. Control gets you through the FDA — and the data room.
Lock a version for submission or the data room. It can't drift, and the full history behind it is one click away.
Your documents carry your company's identity. Regulators and partners see you — not your software vendor.
Electronic signing that re-verifies identity at the moment of signing, with designated QA approvers.
Compliance settings changeable only by workspace owners — and every change is audit-trailed.
Inspection history, quality agreements, and qualification status for every vendor — the package a pre-approval inspection expects to see.
One workspace, up to 20 seats, 2,500 AI actions a month — the controls of a quality organization without building one.
Talk to us about a Validated workspace — we'll walk your team through the controls, the export locks, and the qualification story.
Try the demo