Some sites can't put batch data in someone else's cloud — sovereignty, defense work, contractual constraints, or sites where the WAN drops every Tuesday. V5 On-Prem is the same platform, deployed on your hardware (or your private cloud), with the same UX, the same validation package, and zero feature gap from the SaaS edition.
Sovereignty, classified work, contractual data-residency clauses, or unreliable connectivity mean cloud is a non-starter for many plants — and the vendor's answer is 'we'll get there in v.next.'
Defense, certain CMO contracts, and some government health agencies require an air-gapped deployment that never touches the public internet. Most cloud-first SaaS vendors can't ship it.
The on-prem product is the abandoned codebase. Cloud users get the features; on-prem users get the maintenance patches.
Without a vendor IQ/OQ/PQ package mapped to your URS, validation is 6–12 months of internal effort before the first batch runs.
V5 On-Prem is the same codebase as V5 Cloud — same UI, same APIs, same release cadence. Your on-prem site gets every feature the cloud site does, in lockstep.
V5 runs fully disconnected: offline license activation, in-perimeter updates via signed packages, optional one-way data diode for export-only telemetry.
Sized reference architectures for 50 / 500 / 5,000 users, Kubernetes or VM, Postgres HA. The vendor IQ/OQ/PQ + traceability matrix shortens internal validation to gap testing.
SAML 2.0 SSO, LDAP / AD bind, SCIM provisioning, certificate auth, optional FIDO2 hardware keys for Part 11 e-signature.
Encrypted PITR backups, hot/warm DR, and signed export bundles for FDA/EMA inspection — independent of the live system.
No — it's the same codebase deployed differently. Same UI, same APIs, same release cadence. On-Prem sites get every feature cloud sites do, in lockstep.
Yes. Offline license activation, signed in-perimeter update packages, no outbound network requirement. Optional one-way data diode for export-only telemetry.
Vendor IQ/OQ/PQ, traceability to a sample URS, risk assessment, GAMP 5 category mapping, and a signed validation summary. Customer-side validation focuses on gap testing, not a from-scratch project.
Sized reference designs from single-VM (under 50 users) to multi-region HA on Kubernetes with Postgres HA + PITR. We publish hardware specs in the on-prem specification PDF.
Free trial, no card. Live in 7 days with guided onboarding.