GxP cloud your QA can sign off on — without a shared-responsibility argument.
V5 Ultimate is a GxP-validated cloud platform for regulated manufacturers in the US, UK and Canada. Choose multi-tenant SaaS for fastest go-live, or single-tenant private cloud on Azure or AWS for validated pharma and medical-device deployments. Validation evidence, shared-responsibility matrix and infrastructure qualification — all included.
You need a GxP cloud because on-prem is expensive — and consumer SaaS won't sign the paper.
Your incumbent SaaS won't provide qualification of the infrastructure
The shared-responsibility matrix is a diagram, not a document
Data residency is required (UK, EU, Canada) and your vendor can't commit
Validated clients are told 'multi-tenant SaaS only' with no private option
Change notifications from the vendor arrive after the change, not before
Your qualification pack is a marketing PDF, not IQ evidence
GxP cloud, done to a regulator's satisfaction — not a marketing team's.
Deployment options
Multi-tenant SaaS, single-tenant Private Cloud (Azure or AWS), or on-premises — same code, same validation posture.
Infrastructure qualification
IQ of the underlying environment (region, tenancy, network, HSM, backup), reissued on any material change.
Shared-responsibility matrix
A signed, per-clause matrix showing who does what — vendor, V5, customer QA — for every Part 11 / Annex 11 requirement.
Advance change notification
Material changes announced 60+ days ahead with impact assessment and validation delta — not surprise upgrades.
Data residency + isolation
UK, EU, US, Canada, Australia regions available; single-tenant instances for validated clients.
Backup, DR and continuity
RPO / RTO commitments, tested restore evidence, business-continuity documentation — reviewable on request.
Why validated life-science clients pick V5 GxP cloud.
- First signed record within 30 days of tenancy provisioning
- Infrastructure IQ delivered with the instance — not billed separately
- Zero-finding cloud-provider audits under MHRA and FDA inspection regimes
- Independent Part 11 / Annex 11 assessment publishing August 2026
- Same instance runs GMP, GLP and GDP — one validation, one region, one bill
GxP cloud aligned with every regime your site is inspected under.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — covered out of the box.
GAMP 5 Second Edition
Category 4 configured product with documented critical thinking. CSA-aligned test evidence delivered with onboarding — not a six-month after-the-fact project.
GxP cloud, answered.
What is GxP cloud?
A cloud-hosted platform that meets Good-x-Practice regulatory requirements — validated under GAMP 5, running Part 11 / Annex 11 electronic-record and e-signature controls, with infrastructure qualification and a shared-responsibility matrix documented for QA sign-off.
Multi-tenant SaaS vs private cloud — which do we need?
Non-validated evaluation, food, cosmetics, and most contract-manufacturing workloads deploy on multi-tenant SaaS. Validated pharma, medical-device and biotech clients typically choose single-tenant Private Cloud (Azure or AWS) — same code, isolated tenancy, dedicated change window.
Where is the data hosted?
V5 SaaS regions cover the US, UK, EU, Canada and Australia. Private cloud tenancies are provisioned in the region the customer selects — including for UK data-residency and EU GDPR requirements.
Do you provide infrastructure qualification (IQ)?
Yes. Every V5 tenancy ships with infrastructure qualification of the underlying region, tenancy, network and backup posture — reissued on any material change.
How does the shared-responsibility model work?
V5 publishes a signed, per-clause shared-responsibility matrix mapping each Part 11 / Annex 11 requirement to the accountable party — cloud provider (Azure/AWS), V5, or customer QA. It's a document your QA reviews, not a marketing diagram.
See a GxP cloud tenancy stood up — validated in weeks.
Free trial. Multi-tenant SaaS or private cloud. Validation evidence included.