GxP-Cloud is the #1 community cloud for European life sciences. The infrastructure is already qualified. The quality system is already in place. You start at the finish line.
Building a GxP-compliant environment on public cloud requires your team to own infrastructure qualification, change control, compliance documentation, audit defence, and ongoing quality oversight. That is not what you hired them to do.
GxP-Cloud assumes 60 to 95 percent of that burden from day one. Your team focuses on the application and the science. We handle everything underneath.
Over 80% of engineers with experience supporting validated systems choose Validated Cloud the next time they have a choice.
Calculate your GxP burden →Every service runs under a GxP quality system aligned to EMA, MHRA, and FDA expectations. Audit-ready by design, not by preparation.
Managing an OS in a GxP environment is the messiest part of regulated IT. Patches can break validated applications. Security tools quarantine legitimate files. Dependencies shift without warning. We take all of that on. Your engineering team moves from doers to reviewers.
Learn more →Secure, fully qualified compute, storage, and networking. Pre-built IQ/OQ documentation included. Firewalls, antivirus, IDS/IPS managed and logged. The physical layer, done right, documented, and ready to defend in an inspection.
Learn more →GxP-qualified hosting for SAS, Posit (RStudio), and regulated analytics platforms. Run SAS and Posit side by side. Reusable IQ/OQ/PQ templates reduce validation effort significantly. Purpose-built for pharma and biotech data teams.
Learn more →S3 and Blob compatible. Validated data archive, data lake, clinical data sharing between Sponsors and CROs, NGS data, lab and manufacturing backups. Military-grade security. Audit-ready out of the box. No additional configuration required for compliance.
Learn more →Encrypted, validated backups replicated across geographic zones. Reserved failover resources. Annual DR testing. Fully aligned to Annex 11 and 21 CFR Part 11. When something fails, your recovery is qualified, documented, and defensible.
Learn more →Integrated QMS, formal change control, IQ/OQ packages, and an independent QA team that defends your deployment in audits. CSV/CSA support, SOP authoring, gap assessments, and inspection readiness preparation. We speak both IT and Quality.
Learn more →Not sure which services apply to your environment? A 30-minute conversation is usually enough to map it out.
Book a consultation| Responsibility | GxP-Cloud | Public cloud | Do it yourself |
|---|---|---|---|
| Infrastructure qualification (IQ/OQ) | ✓ Delivered with service | ✕ Not provided | ✕ You author and execute |
| Formal change control | ✓ QA-approved, documented | ✕ No notification to you | ~ Internal QA manages |
| GxP quality system (EMA / MHRA / FDA) | ✓ Inspectable, Part 11 aligned | ~ ISO 9001 only, not auditable | ✕ You build and maintain |
| Platform patching under QA oversight | ✓ Managed, documented | ~ Optional tools, you configure | ✕ Internal IT manages |
| Audit defence (EMA / MHRA / FDA) | ✓ Our QA team defends | ✕ Your team defends alone | ✕ Your team defends alone |
| Disaster recovery (qualified) | ✓ Included, tested annually | ~ You configure and qualify | ✕ You design and maintain |
| 24/7 life sciences expert support | ✓ LS professionals only | ~ Tiered, no LS context | ✕ Internal only |
The cost of running on public cloud looks lower until you account for the qualification work, the ongoing maintenance, and the cost of defending it when an inspector asks for documentation you do not have.
Speak to a GxP specialistEMA and MHRA inspectors are asking about cloud infrastructure with increasing frequency. Most life sciences companies did not plan for this. The ones who are ready all have one thing in common: they treated infrastructure qualification as a first-order concern, not an afterthought.
Our quality system has been reviewed by hundreds of auditors across EMA, MHRA, and FDA regulated environments. We participate in inspections alongside our clients. Our QA team defends what we build.
We are not a US cloud provider with a European region. We are a purpose-built GxP infrastructure company with EU and US entities, EU-based data centres, and a quality framework that leads with EMA and Annex 11.
Our quality framework is built around EMA and Annex 11 first. FDA and 21 CFR Part 11 alignment is included. MHRA post-Brexit guidance is addressed specifically for UK-based customers.
Your data stays in the EU unless you specifically instruct otherwise. Full control over storage location, access policies, and residency. No offshore replication without your explicit direction.
European customers contract through Validated Cloud BV, Hoofddorp, Netherlands. No cross-border legal complexity. Straightforward procurement for EU-based organisations.
Tier 3 data centres in Amsterdam and Dublin, with US facilities in Massachusetts and California for organisations that need transatlantic capability.
We offer flexible contracting through Validated Cloud BV (EU) and Validated Cloud Inc (US), allowing clients full control over data residency and simplifying global partnerships.
Our EU team is available to discuss your specific regulatory environment, data residency requirements, and qualification approach.
From pre-commercial biotech to global pharma, our platform scales with your organisation and your regulatory obligations.
Enter the GxP world cost-effectively with Quality System as a Service. Start at the finish line with a mature, comprehensive GxP infrastructure from Phase II through regulatory readiness.
Scale GxP systems efficiently with hybrid-cloud infrastructure that reduces cost as you grow. Keep your compliance posture strong through commercialisation and beyond.
A pre-qualified, audit-ready infrastructure that accelerates customer deployments and shortens sales cycles. Pre-sales auditability and RFP support for regulated software vendors.
Partner with the GxP cloud leader your clients already trust. Free up resources for high-impact activities while your infrastructure compliance is handled by professionals.
Comprehensive GxP-compliant infrastructure for medical device organisations, from secure document management and FDA cybersecurity submissions to validated cloud infrastructure and audit defence.
Whether you are running SAS, Posit, a LIMS, a QMS, or a MES, our community cloud is built for the full regulated application stack. One platform, one quality system, one audit trail.
Not sure where you fit? Most of our clients found us when a specific compliance challenge surfaced. Let us start there.
Start the conversation Explore by client typeWith big budgets for technology and consulting, Big Pharma projects were running with budgets of several hundred thousand dollars. We set out to deliver the same level of compliance and quality for a fraction of the cost — and that is exactly what we do.
Book a 30-minute consultation with our EU team. We will assess your current environment, explain where your GxP gaps are, and outline what qualified hosting looks like for your organisation. No commitment required.