GxP-Cloud takes on the day-to-day complexity of managing a validated platform and infrastructure. OS patching, security tools, change control, and QA oversight — all handled by professionals who live and breathe GxP every day. Your team moves from doers to reviewers and approvers.
In a regulated environment, every patch is a potential compliance event. A routine OS update can disrupt a validated application. An antivirus tool can quarantine a legitimate file. A dependency upgrade can invalidate qualification documentation that took months to produce.
Most life sciences companies handle this by asking their IT team to become GxP experts, and asking their QA team to become IT experts. The result is a constant tug of war between engineering velocity and compliance rigour — with your regulated systems caught in the middle.
GxP-Cloud PaaS ends that dynamic. We take on the platform layer entirely. Your engineering team's role shifts from managing GxP operations day to day to reviewing and approving what we do. That is the right use of their time.
Even routine OS updates can disrupt application functionality or server behaviour, triggering revalidation requirements.
Antivirus, anti-malware, and anti-ransomware tools can quarantine legitimate files. Their behaviour keeps evolving — and every change is a compliance event.
When a validated application's dependencies are patched or upgraded, it can jeopardise functionality and invalidate compliance documentation.
Server management tools, monitoring platforms, and supporting software are frequently updated — sometimes impacting stability across your validated stack.
Our platform combines IT best practice with the rigorous security, documentation, and compliance requirements of GMP, GCP, GLP, and the regulatory bodies that oversee them.
OS patching, monitoring, alerting, break-fix, database maintenance, and Citrix management — all executed under a documented, QA-approved change control process. Every change is reviewed before it happens.
For organisations that do not have a qualified IT professional available to manage a validated environment, PaaS bridges the gap immediately. No hiring. No onboarding. No training on GxP requirements.
Every support team member is trained on your environment's Standard Operating Procedure. When someone touches your system, they know your system. There is no generic helpdesk tier involved in GxP operations.
You gain a fully matured GxP quality system plus the engineering and quality experts to manage and maintain validated systems in an audit-ready state. Our QMS has been reviewed and approved by hundreds of auditors.
Nothing happens to your environment without a signed, documented approval. Your team reviews and approves. We execute. The audit trail is complete, current, and defensible from day one.
Compliance does not end at deployment. It is an ongoing commitment. Our team maintains continuous documentation, performs periodic reviews, and ensures your environment remains in a qualified state throughout its lifecycle.
Over 80% of engineers with experience supporting validated systems choose Validated Cloud the next time they have a choice.
Book a PaaS consultationValidated Cloud transforms your engineering team's role. Day-to-day GxP operations are handled by professionals who live and breathe GxP every day. Quality teams no longer need to repeatedly train IT staff on compliance standards — they trust our Quality team to oversee all engineering activities with audit readiness in mind.
The result is a cleaner, faster, more defensible operation. Engineering velocity increases because changes are managed and documented. Quality confidence increases because the oversight is independent and consistent.
GxP-Cloud IaaS provides the qualified compute, storage, and networking layer that makes everything above it defensible. Pre-built IQ/OQ documentation is included. Security controls are managed, logged, and qualified. Capacity and performance are monitored continuously.
For customers looking to manage their own application layer while outsourcing the infrastructure qualification and security burden, IaaS is the right starting point. For most customers, IaaS and PaaS together represent the complete transfer of GxP infrastructure responsibility.
Our infrastructure operates from Tier 3, ISO 27001 and SSAE 18 Type II data centres in Amsterdam, Dublin, Massachusetts, and California. Cross-region replication is available for disaster recovery and geographic redundancy.
Fully qualified servers, high-speed disk storage, and object storage, deployed and documented to IQ/OQ standards.
Infrastructure qualification documentation is delivered with the service. No months of authoring before you can start deploying applications.
Firewalls, antivirus, anti-malware, IDS/IPS — all managed, logged, and qualified. Security is not a tool you configure. It is a service we maintain.
Proactive monitoring ensures your environment performs within defined parameters. Capacity planning is managed before it becomes a problem.
Encrypted, validated backups with monitored daily integrity checks. Recovery environments are pre-qualified and reserved for rapid failover.
Amsterdam, Dublin, Massachusetts, and California. ISO 27001 and SSAE 18 Type II certified. Cross-region replication available for EU data sovereignty and DR.
Every IaaS and PaaS service operates under a GxP Quality Management System aligned to EMA, MHRA, and FDA expectations. This is what separates qualified hosting from cloud hosting with a compliance checklist.
Aligned to 21 CFR Part 11 and Annex 11. Inspectable and auditable at any time. Not ISO 9001 only — a genuine GxP quality system that an EMA or MHRA inspector can walk through.
Every infrastructure and platform change goes through a QA-approved formal change control process with objective evidence. No uncontrolled changes. No surprises in your audit trail.
Standard IQ/OQ documentation is included with every deployment. Custom qualification packages are available for specific regulatory or audit requirements.
Our Quality team operates independently from Engineering. They review all technical activities, maintain the audit trail, and attend inspections alongside you.
Integrated risk assessments for all changes and periodic reviews across the environment. Regulatory update monitoring with actioned responses when guidance changes.
Every operational activity from installation through lifecycle management is governed by documented SOPs. Nothing happens outside a procedure.
Infrastructure qualification is increasingly a first-line inspection topic, not a footnote. Companies that built on public cloud without planning for this are finding out the hard way. The ones who are ready all made the same decision early.
Our quality system has been reviewed by hundreds of auditors. We attend inspections alongside our clients. Our independent QA team defends every deployment we manage.
Contract through Validated Cloud BV, Hoofddorp, Netherlands. EU data centres in Amsterdam and Dublin. GDPR-compliant data residency. EMA Annex 11 and MHRA guidance embedded in our quality framework from the ground up.
Book a 30-minute consultation with our EU team. We will assess your current platform and infrastructure setup, identify your GxP gaps, and outline what PaaS and IaaS looks like for your specific environment. No commitment required.