GxP-Cloud Object Storage is S3 and Blob compatible, fully qualified against EMA, MHRA, and FDA standards, and comes GxP-compliant from the moment you activate it. No additional configuration required. No months of qualification work before you can store regulated data.
GxP S3 compatibility is rapidly becoming a standard component of pharmaceutical and biotech software. Our storage integrates with the systems you already use and qualifies the layer underneath them.
Move your validated archive data to a read-only GxP S3-compatible bucket. Secure, inexpensive long-term storage with granular access control. We have simplified the platform so that anyone can leverage it — and we provide complimentary onboarding guidance to get you there.
A truly GxP-compliant data lake for structured and unstructured validated data. Access your S3-compatible buckets from anywhere, or from a fully compliant clinical data workspace. Pull directly into SAS, Posit, Python, Spotfire, and more without breaking your compliance posture.
Granular security settings allow sponsors and CROs to share clinical data quickly and without chain of custody issues. Controlled access at the bucket level, full audit trail of who accessed what and when. Share with confidence across organisational boundaries.
GxP S3 compatibility is standard in pharma and biotech software. GxP-Cloud Object Storage integrates with your lab and manufacturing systems to get critical data off-site for archiving, data protection, and as a qualified data integrity repository.
Validated Cloud's GxP S3-compatible storage handles the complex needs of next-generation sequencing data. Reference data, full genomes, or multi-study datasets — infinitely scalable storage designed for the security, scalability, and compliance demands of validated NGS environments.
Use GxP Object Storage as a secure, qualified offsite backup target for your regulated systems. Compatible with leading backup platforms and validated for use as a DRaaS storage target. Geographic replication available across EU and US data centres.
Not sure which use case applies to your environment? A 30-minute conversation is usually enough to identify the right starting point.
Book a consultationWe manage the top-level buckets, security policies, and user accounts to ensure the storage platform operates in a controlled and compliant manner at all times. Our team provides both engineering execution and independent QA oversight — maintaining version control, audit trails, and optional immutable storage configurations to support data integrity requirements.
We also provide an SOP template to guide compliant interaction with the S3-compatible environment. By taking ownership of the infrastructure, security, and compliance layer, GxP-Cloud allows your teams to focus on working with data rather than managing and defending the storage platform.
Optional geographic replication is available between EU and US regions, and can serve as a secure storage target for industry applications including Egnyte.
All data encrypted at rest and in transit. Backups transferred and stored on separate networks and media from production systems.
Manage access at the bucket level simply and effectively. User accounts, security policies, and permission controls are maintained by our team under QA oversight.
Every access event, every change, every download is logged, reviewed, and maintained within our Quality System. Always inspectable.
WORM (Write Once Read Many) configuration available for data integrity requirements that demand immutable records. Fully documented and QA-managed.
We provide a complimentary SOP template to guide how your team interacts with the S3-compatible environment in a controlled and documented manner.
From a few gigabytes to petabyte-scale NGS datasets. Capacity scales on demand without impacting your compliance posture or qualification documentation.
| Capability | GxP-Cloud Object Storage | AWS S3 / Azure Blob | On-premise storage |
|---|---|---|---|
| GxP-compliant out of the box | ✓ Yes — no setup required | No — you configure and qualify | No — you build and maintain |
| EMA / MHRA / FDA qualification | ✓ Delivered with service | Customer responsibility | Customer responsibility |
| Complete audit trail | ✓ Always on, QA-maintained | Requires configuration | Requires design and build |
| Independent QA oversight | ✓ Included | Not provided | Internal QA manages |
| Granular access control under QA | ✓ Managed by our team | Customer configured | Internal IT manages |
| Immutable storage option | ✓ Available, QA-documented | Available, not qualified | Requires specialised hardware |
| GDPR / EU data residency | ✓ EU data centres, EU entity | Configurable, not default | On-premise — your responsibility |
| SOP template included | ✓ Complimentary | Not provided | You author and maintain |
Standard cloud storage is not GxP storage. The difference is not a checkbox. It is a complete qualification framework, an independent QA oversight layer, and documented evidence that your storage environment is inspection-ready.
Speak to a storage specialistEuropean life sciences organisations face clear GDPR and EMA expectations around where regulated data resides and who can access it. GxP-Cloud Object Storage is built for that environment. EU data stays in EU data centres unless you specifically instruct otherwise.
We contract through Validated Cloud BV, Hoofddorp, Netherlands — our EU legal entity — so procurement and contracting is straightforward for European organisations. No cross-border legal complexity. No ambiguity about data residency at the contract level.
Tier 3, ISO 27001 and SSAE 18 Type II certified. Your data does not leave the EU without your explicit instruction.
Granular security policies, documented access logs, and no third-party access without your authorisation. Data privacy is a first-order design requirement, not a setting.
EU entity, Netherlands. Simple, clean contracting for European procurement teams. US capability available through Validated Cloud Inc for transatlantic requirements.
Geographic replication between EU regions and US facilities available for disaster recovery and data redundancy. Configured only at your instruction.
Discuss your specific data residency requirements with our EU team. We will outline the right storage configuration for your regulatory environment and contracting needs.
Regulated data storage is increasingly a direct inspection topic. Inspectors are asking not just where data is stored, but who controls access, how changes are tracked, and whether the storage environment itself is qualified. Standard cloud storage does not answer these questions.
We manage the platform. We maintain the audit trail. We provide the qualification documentation. When an inspector asks about your regulated data storage, the answer is ready because we keep it ready.
EU data centres, EU contracting entity, and a qualification framework that leads with EMA Annex 11 and MHRA expectations. The same military-grade security and scalability of public cloud object storage — with the GxP compliance layer built in from the start.
Book a consultation with our EU team. We will assess your current data storage situation, identify your compliance gaps, and outline what GxP Object Storage looks like for your specific use case. No commitment required.