GxP-Cloud was a quality company before it was a hosting company. Our Quality Management System was established before our first data centre went live. Every service we deliver operates under a GxP QMS reviewed and approved by over 100 auditors across EMA, MHRA, and FDA regulated environments.
That distinction matters. Our quality department is not a compliance add-on. It is the institutional core of everything we do. Every infrastructure deployment, platform change, storage configuration, and support activity is governed by SOPs, reviewed by our Quality team, and documented in a QMS that an EMA or MHRA inspector can walk through at any point.
Beyond the quality infrastructure that underpins our hosting services, we provide standalone quality and compliance services to life sciences organisations at every stage of their regulated journey.
Developing a first QMS, SOPs, or validation methodology from scratch.
Expanding a GxP system landscape or preparing for first regulatory inspections.
Modernising processes or shifting from CSV to CSA principles.
Seeking practical, hands-on expertise to bridge IT and Quality.
Building or maturing a quality framework to support validated deployments.
Entering the GxP world from Phase II through regulatory readiness.
Delivered by quality and validation professionals with direct experience in EMA, MHRA, and FDA regulated environments. Practical, risk-based, and built to last beyond our engagement.
Full validation deliverables for SaaS, COTS, and enterprise GxP systems including Veeva, MasterControl, TrackWise, and DocuSign.
A fully operational GxP Quality Management System from day one — without the internal resource investment of building and staffing one from scratch.
New SOPs and policies for IT, systems, validation, quality management, clinical development and operations, and biometrics — written to current regulatory expectations.
Practical, hands-on guidance from professionals who have been in the inspection room. Gap and risk assessments with prioritised remediation planning.
The operational quality layer that keeps your validated systems in a compliant state day to day — not just at deployment or audit time.
Prepare your organisation, documentation, and team for EMA, MHRA, and FDA inspections — with the benefit of a team that has been in that room many times before.
Not sure which service applies to your situation? Most engagements start with a conversation about where you are and where you need to be.
Book a consultationOur Quality Management System is not designed to satisfy the minimum requirement. It is designed to be reviewed by the most demanding auditors in the industry and to come out stronger every time.
Our goal in every quality services engagement is to get you to a point where you own your compliance posture independently. We are the support system that gets you ready to stand on your own — not a consultancy that profits from extended dependency.
Pre-commercial companies often try to save money on quality infrastructure initially — and then discover the long-term cost when incomplete validation activities fall short just before an EMA or MHRA inspection. That rework costs far more than doing it right the first time.
Validated Cloud's starter quality system gets you from nothing to a quality system that supports deploying and maintaining your first validated computerised systems. When you are ready to own it independently, you take our artefacts, customise them, and they are yours.
A fully operational QMS from day one — while you mature your internal GxP compliance function. Designed for companies that cannot yet justify a permanent quality hire.
Building controls for both FDA and EMA from the outset requires only modest additional effort. Building for one then adapting for the other can double your effort. We help you do it right once.
Our quality framework scales with your programme. From Phase II through NDA or MAA submission, post-marketing, and beyond — one partner who has done this journey before.
To capture the broader GxP market, you need a comprehensive quality framework and productised validation deliverables that put you in control of your software's regulatory positioning. The audit game has changed. Customers now buy first, then audit — creating an uncontrollable list of post-sale requirements. Getting customers to audit first transforms this into a scoped gap analysis before contracts are signed.
Complete documentation suite your customers need for validation. Packages that satisfy the vast majority of prospective customers on the first pass. This investment becomes a profit centre.
Behind every successful GxP engagement is a quality framework customers can audit and trust. Words in the wrong order undermine everything — and customers may never tell you they have lost confidence.
Not ready for a permanent quality function? We act as your quality department through QMS as a Service, covering all the basics from day one while you mature your GxP compliance capability.
A pre-qualified, audit-ready posture that accelerates customer deployments and shortens sales cycles. Customers audit your framework before contracts are signed — keeping you in control.
Regulatory inspectors do not just look at your systems. They look at the quality framework that governs them. The organisations that sail through inspections built their quality foundation early and maintained it continuously.
Our goal in every engagement is practical, sustainable compliance — not an extended consulting relationship. We get you to the point where you own your quality posture independently.
Our Quality team has direct experience supporting EMA and MHRA inspections. We lead with Annex 11 and current MHRA guidance in every engagement. FDA alignment is included, not substituted.
Book a 30-minute consultation with our Quality team. We will discuss where you are, where you need to be, and the most direct path between the two. No commitment required.