Regulatory inspections of cloud infrastructure and computerised systems are increasing across European life sciences. The organisations that answer confidently all made the same decision: they treated inspection readiness as a permanent operating state, not a pre-audit project. GxP-Cloud is built for that approach.
If your infrastructure runs on GxP-Cloud, you are already inspection-ready. Our environments are audit-ready by design. Documentation is current. Change control is active. Our QA team attends inspections alongside you. You do not scramble when the inspector arrives. You are ready before they announce the visit.
We track what regulatory agencies actually examine during inspections through our dedicated audit portal. The questions below are not theoretical. They are drawn from real inspection experience across EMA, MHRA, and FDA environments.
Inspectors expect documented qualification evidence for the infrastructure hosting your regulated systems — not just for the applications themselves.
Annex 11 requires formal change control for computerised systems. Infrastructure changes made without documented approval are findings.
Business continuity and disaster recovery procedures must demonstrate that data integrity is preserved — not just that systems come back online.
EU data sovereignty and GDPR compliance are regulatory requirements for European organisations, not optional. Inspectors ask where data is stored and who has access.
OS updates in validated environments are change control events. Inspectors expect documented procedures for how patching is managed without disrupting validated applications.
A DR plan without documented test evidence is not a compliant DR plan. Annex 11 expects periodic testing with results available on request.
This question has a complicated answer on public cloud. On GxP-Cloud it has a clean one: we are, and here is the documentation that proves it.
ALCOA+ principles apply to system access logs, change records, and backup activities — not just to scientific data. Inspectors look at the infrastructure audit trail too.
The organisations that perform best in EMA and MHRA inspections did not prepare for their last inspection. They have been prepared continuously. Documentation is always current. Change control is always active. The audit trail is always complete. When an inspector announces a visit, nothing changes operationally — because it was already ready.
That is exactly how GxP-Cloud environments operate. We do not assemble documentation when an inspection is announced. We maintain it continuously because continuous maintenance is what our Quality System requires. The inspection finds a steady state, not a scramble.
We monitor evolving EMA and MHRA inspection focus areas through our audit portal. When agency focus shifts — and it does — we act on it proactively. Your environment stays aligned to current expectations, not last year's.
Our Quality team does not hand you documentation and step back. We attend regulatory inspections alongside our customers and defend the infrastructure we manage. You are never facing an inspector about your hosting environment alone.
Pre-inspection gap analysis, documentation review, team preparation, and mock inspection support — available as standalone services regardless of your current infrastructure. Contact us to discuss your specific situation.
These are not hypothetical. They are the questions that surface in internal pre-inspection reviews, in QA assessments of new hosting arrangements, and in vendor qualification questionnaires from pharma customers. The organisations that answer them confidently all have one thing in common.
Not just for the application. For the servers, storage, networking, and platform layer underneath it.
Inspectors ask for a change log. The answer needs to be immediate and complete.
GDPR and EMA data sovereignty requirements are procurement-level concerns for European organisations.
In a GxP environment, patching is a change control event. Your QA team needs a documented answer.
Annex 11 expects periodic testing. The answer needs a date and documented evidence.
This question needs a clear, documented answer — not a conversation between IT and QA.
If any of these questions does not have an immediate, documented answer today — that is the gap to close before the next inspection announcement.
Book an inspection readiness consultationInspection readiness on GxP-Cloud is not a feature you activate. It is the consequence of how we operate every day. These four elements make the difference between organisations that answer inspection questions confidently and those that scramble to assemble evidence.
IQ/OQ documents, change records, qualification evidence, and audit trails are maintained continuously. Not compiled when an inspection is announced. Not assembled from scattered sources. Always ready, always current, always downloadable.
Every engineering activity — every patch, every change, every configuration — is reviewed by our independent Quality team before it happens. The oversight is continuous, not periodic. When an inspector asks who reviewed a change, the answer is always documented.
We track what EMA, MHRA, and FDA inspectors focus on through our dedicated audit portal. When agency focus areas shift, we respond proactively. Your environment stays aligned to what inspectors are looking at now — not what they were looking at two years ago.
When an EMA or MHRA inspector asks about your hosting infrastructure, you are not on your own. Our Quality team attends inspections alongside our customers and defends the environments we manage. Decades of combined inspection experience, in the room with you.
Every GxP-Cloud service is designed with inspection readiness as a first-order requirement. The infrastructure is qualified, the platform is managed under QA oversight, and the storage is audit-ready from day one. Inspection readiness is the natural outcome.
Our quality framework leads with EMA Annex 11 and MHRA guidance. We track what European regulatory agencies examine during inspections and align our environments to those expectations proactively. EU data sovereignty and GDPR compliance are built in — not configured on request.
Book a 30-minute consultation with our EU team. We will assess your current inspection readiness posture, identify the gaps that would surface in an EMA or MHRA inspection today, and outline what needs to change. No commitment required.