On-prem · Self-hosted · Air-gapped · GxP
On-premises QMS and MES on your own servers.
Run V5 on your own hardware or private cloud where policy requires it.
One codebase, two deployment modes
V5 On-Prem is the same codebase as V5 Cloud — same UI, same APIs, same release cadence.
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…
Hardware Reference Designs + Validation Package
Sized reference architectures for 50 / 500 / 5,000 users, Kubernetes or VM, Postgres HA.
What goes wrong today4 common problems
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 vendor IQ/OQ support, your team carries the whole validation effort before the first batch runs.
Everything V5 does here5 capabilities
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. With Enterprise, IQ/OQ and validation support are scoped in your quote; your team plans, runs and approves PQ and intended-use validation.
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.
How it works, step by step5 steps
On-prem lifecycle.
- Reference Architecture Applied. Hardware and network sized to workload.
- IQ/OQ Executed. Automated where safe; witnessed where required.
- Site-Specific PQ. System-assist for private-cloud and on-prem tenants.
- Runbook Active. Backup/DR/HA per documented runbook.
- Customer-Instigated Release. Delta reviewed; validation pack executed; previous versions retained.
What to look for when choosing
On-prem QMS/MES must be operable by your IT team, not require a phone call to the vendor for every log rotation. Criteria below tell the two apart.
Air-Gap Capable
Does the system run with no outbound internet at all? Air-gap operable, including licensing and update flow.
Validation Support
What IQ/OQ and validation support is available? Enterprise includes IQ/OQ and validation support; exact deliverables are set in your accepted quote/SoW. Your team plans, runs and approves intended-use validation and PQ as applicable.
Update Process under Change Control
Are updates version-pinned with a documented delta? Customer-instigated updates with signed delta and previous versions maintained in Git.
Backup, Restore and BCP
Are backup/restore, HA and DR procedures documented and tested? Documented and tested runbook per release.
Sizing and Reference Architecture
Do you get a real sizing guide against real workload signals? Sizing guide with reference architecture — see /resources/on-prem-specification.
V5 Compared with Other Approaches
On-prem V5 vs cloud-only vs legacy on-prem.
| capability | spreadsheet | legacy Qms | v5 |
|---|---|---|---|
| Air-gap | N/A | Sometimes | Yes |
| Validation pack | N/A | Consultant | Included with Enterprise |
| Customer-instigated updates | N/A | Vendor-driven | Native, no push |
| Runbook | N/A | Ad-hoc | Documented and tested |
Regulations this supportsYour quality team stays responsible for compliance
On-prem is a data-sovereignty and validation story more than a features story.
GAMP 5
Your team confirms the category and scales testing to risk; Enterprise adds IQ/OQ and validation support.
EU GMP Annex 11 §4.5
V5 SDLC documented and shared under MSA; source-of-truth in Git.
21 CFR Part 11 §11.10(k)
Signed doc set per release with prior versions retained.
Standards Referenced
- 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
Common questions4 answers
- 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?
- With Enterprise: IQ/OQ and validation support, traceability to a sample URS and a risk assessment, with exact deliverables set in your quote. Your team decides the GAMP 5 category, runs PQ and user acceptance for your intended use, and approves the result.
- 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.