On-premises QMS & MES — full GxP, your data, your network.
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.
What breaks without this.
Cloud-only vendors can't sell into half your sites
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.'
Air-gap is a hard requirement, not a nice-to-have
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.
On-prem from legacy vendors means 2005 UX
The on-prem product is the abandoned codebase. Cloud users get the features; on-prem users get the maintenance patches.
Validating your own deployment is a project, not a download
Without a vendor IQ/OQ/PQ package mapped to your URS, validation is 6–12 months of internal effort before the first batch runs.
Records-by-execution. Compliance, by design.
One codebase, two deployment modes
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.
Air-gap capable, with offline activation
V5 runs fully disconnected: offline license activation, in-perimeter updates via signed packages, optional one-way data diode for export-only telemetry.
Hardware reference designs + validation package
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.
Identity that fits your network
SAML 2.0 SSO, LDAP / AD bind, SCIM provisioning, certificate auth, optional FIDO2 hardware keys for Part 11 e-signature.
Backup, DR and inspection-ready exports
Encrypted PITR backups, hot/warm DR, and signed export bundles for FDA/EMA inspection — independent of the live system.
Proof points
- Same release cadence as V5 Cloud — no feature gap
- Air-gap deployments live in defense, biodefense, and classified CMO programs
- Validation pack: IQ/OQ/PQ, URS traceability, risk assessment, GAMP 5 category mapping
- Reference architectures from single-VM (under 50 users) to multi-region HA
- Postgres HA + PITR; Kubernetes or plain VMs; SAML/LDAP/SCIM
- On-Prem Addendum + signed validation summary included in MSA
Built to satisfy
- 21 CFR Part 11 (Electronic records & signatures)
- 21 CFR 820 (QSR — medical devices)
- 21 CFR 211 (Pharma GMP)
- EU GMP Annex 11 (Computerised systems)
- GAMP 5 (validation lifecycle)
- EU GDPR / data-residency
Frequently asked questions
Is V5 On-Prem a different product from V5 Cloud?+
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.
Can V5 run fully air-gapped?+
Yes. Offline license activation, signed in-perimeter update packages, no outbound network requirement. Optional one-way data diode for export-only telemetry.
What does the validation package cover?+
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.
What infrastructure do we need?+
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.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.