Home/ About GxP-Cloud
A Validated Cloud Company

A quality company
that does hosting.
Not the other way around.

GxP-Cloud is the European presence of Validated Cloud — the #1 community cloud for life science regulated systems. We have been purpose-built for this industry since 2008. Quality came first. The data centres came second. That sequence has never changed.

Two entities. One quality standard.
Validated Cloud BV

European entity. Hoofddorp, Netherlands. EU contracting, EU data centres, EMA and MHRA-first quality framework. The entity European organisations contract with.

Validated Cloud Inc

US entity. Waltham, Massachusetts. FDA and 21 CFR Part 11 aligned. US data centres in Massachusetts and California. For US and global organisations.

One quality system

Both entities operate under the same GxP Quality Management System, reviewed by over 100 auditors across EMA, MHRA, and FDA environments.

Who we are
Since 2008purpose-built for life sciences
100+auditors have reviewed our QMS
4 countriesEU and US data centre footprint
EU + USentities for flexible contracting
Our story

We started because Big Pharma was building the same thing over and over again. We decided to build it once.

The concept started in 2008 when our founders built private GxP clouds for Big Pharma. The overlap between them was striking. The same qualification work. The same SOPs. The same quality controls. The same cost.

Big Pharma was routinely building their internal private GxP clouds almost identically to their peers — with budgets of several hundred thousand dollars and timelines stretching long before their Quality departments would sign off. We came to question the value of all those custom projects. Would smaller pharma need the same custom work? What if a company needed only a handful of validated systems and did not have the budget or appetite to build it the right way? Where were they to turn?

We started Validated Cloud to solve that problem. We built the platform once, properly, and made it available to any life sciences organisation that needed a compliant foundation without the cost of building their own. The same level of qualification, the same quality system, the same regulatory alignment that Big Pharma was spending hundreds of thousands to achieve — available at a fraction of the cost through a shared, community cloud model.

Over the years the data centre footprint has grown, additional regulations have been integrated, and we have positioned ourselves as the best life sciences community cloud for regulated systems anywhere. GxP-Cloud is our European presence — EMA-first, GDPR by design, EU data sovereignty as standard.

2008

The idea

Founders build private GxP clouds for Big Pharma and recognise the pattern. The same qualification work, repeated by every organisation, at enormous cost. Validated Cloud is conceived as the alternative.

QMS

Quality first

The Quality Management System is established before the first data centre goes live. A deliberate, defining decision. We are a quality company that does hosting — not a hosting company that adapts to compliance.

US

US expansion

Data centres established in Massachusetts and California. Validated Cloud Inc incorporated in Waltham, MA. FDA and 21 CFR Part 11 alignment embedded from the start.

EU

European entity

Validated Cloud BV established in Hoofddorp, Netherlands. EU data centres in Amsterdam and Dublin. EMA Annex 11 and MHRA guidance become the primary regulatory framework for European operations.

GxP

GxP-Cloud launch

GxP-Cloud established as the European-facing brand and platform — EMA-first, GDPR by design, EU data sovereignty as standard. A dedicated presence for the European life sciences market.

Now

The #1 community cloud for life sciences

Over 100 auditors have reviewed and approved our QMS. Thousands of regulated workloads hosted. The most mature GxP community cloud in the industry.

Why organisations choose us

Four reasons life sciences organisations choose GxP-Cloud over building their own.

We were able to do for our customers what Big Pharma was spending hundreds of thousands to build — at a fraction of the cost, with a quality system that has been reviewed and hardened by over 100 auditors.

Time

Our built-in processes, qualified technical stack, and validation and qualification library allow customers to focus on the validation of their software — not on building and documenting the environment underneath it. You receive a fully documented, qualified environment ready to install your application.

Money

Server templates are ready to deploy. All validated infrastructure and supporting systems — backups, antivirus, firewalls — are ready because they are always needed. Deployment SOPs, maintenance SOPs, and policies are in place. This saves substantial cost over self-development at every stage of your programme.

Unique outsourcing

We provide the IT infrastructure, GxP IT staff, and an independent Quality team. This team oversees our service and completely frees customers from regulatory infrastructure burden. There is an area of customer business knowledge needed in the GxP system space. We take care of everything else.

Community cloud maturity

Our service is 100% dedicated to the life sciences community to host and support regulated systems. Our Quality system has been reviewed by over 100 auditors, and that collaboration has created an extremely mature service offering. When you join GxP-Cloud, you benefit from every audit that came before you.

Our European footprint

EU data centres. EU entity. EMA-first quality framework.

GxP-Cloud is our European presence — specifically built for the regulatory environment that European life sciences organisations operate in. We are not a US platform with a European region. We are a European GxP infrastructure company with a US capability, contracting through a Dutch entity with EU-based data centres as the default.

Our quality framework is built around EMA Annex 11 first. MHRA guidance for UK-based organisations is addressed specifically. FDA and 21 CFR Part 11 alignment is included for global programmes. GDPR compliance is structural, not configured. Your data stays in the EU unless you specifically instruct otherwise.

EMA Annex 11 MHRA GxP 21 CFR Part 11 GDPR ISO 27001 ISO 9001 GAMP 5 ALCOA+ HIPAA ISO 13485
Speak to our EU team
Data centre locations
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EU Primary

Amsterdam

Netherlands. Tier 3. ISO 27001. SSAE 18 Type II.

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EU Secondary

Dublin

Ireland. Tier 3. ISO 27001. SSAE 18 Type II.

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US East

Waltham, MA

Massachusetts, USA. Tier 3.

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US West

California

California, USA. Tier 3.

EU contracting entity

Validated Cloud BV • Hoofddorp, Netherlands • EU-registered entity for European contracting. No cross-border legal complexity for European procurement teams.

Our channel partners

Trusted by the organisations that implement and manage GxP systems for life sciences.

Our channel partner network includes some of the most respected names in life sciences IT and analytics. These organisations deploy, qualify, and support GxP systems on Validated Cloud infrastructure — recommending us to their customers because our platform makes their work easier and their customers' audits cleaner.

Consultancy — SAS analytics

OCS Consulting

SAS Gold Partner operating across Northern Europe — BeNeLux, DACH, and beyond — with a dedicated Life Sciences division. Installs, qualifies, and supports SAS environments on Validated Cloud infrastructure.

Consultancy — Posit / R analytics

Jumping Rivers

Certified Posit Full-Service Partner, one of a small number globally with this designation. Deploys and manages Posit environments including Connect, Workbench, and Package Manager on Validated Cloud infrastructure.

SaaS vendor — Spotfire analytics

Revvity Signals

Holds exclusive rights to sell and support Spotfire in the life sciences market. Widely used in pharma and biotech for clinical data review, medical review, risk-based monitoring, and pharmacovigilance.

SaaS vendor — manufacturing execution

POMS Corporation

Purpose-built MES provider for pharma, biotech, cell and gene therapy, and medical device manufacturing. References Validated Cloud by name on their website as the preferred partner for cloud-hosted MES deployments.

You focus on science. We handle IT and compliance.

Book a 30-minute consultation with our EU team. We will discuss your current environment, your regulatory obligations, and what GxP-Cloud looks like for your specific situation. No commitment required.

EU +31 20 399 1018  •  US +1 617 849 8650  •  info01@validatedcloud.com