Enterprise Platform: Security & Compliance

Security, Compliance & Data Sovereignty

Your data stays yours. Golden Helix is built for institutions that demand complete control over patient genomic data—with certifications, deployment flexibility, and audit trails to prove it.

ISO 13485 Certified QMS
CE Marked (IVDR)

Certified for Clinical Genomics

Golden Helix maintains the certifications and regulatory marks that clinical laboratories require. Our quality management system governs every stage of software design, development, and delivery.

ISO 13485:2016

Certified quality management system for the design, development, and delivery of medical device software. Governs our entire software lifecycle from requirements through release.

CE-IVDR 2017/746

VarSeq Dx is CE marked for in vitro diagnostic use in the European Economic Area. Installation verification and tiered proficiency certification ensure clinical readiness before diagnostic use.

Workflow Validation

Field Application Scientists support transparent NGS workflow validation from sample prep through reporting. No black-box pipelines—you understand and control every step of your validated process.

Security by Architecture, Not by Promise

Multi-tenant SaaS platforms inherit shared risk. Golden Helix eliminates that risk category entirely by putting the full software suite on your infrastructure, behind your firewall.

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HIPAA technical safeguards

Access Controls

LDAP/Active Directory integration enforces role-based access to patient data. SSO via SAML means credentials are managed at the institutional level with your existing password policies.

Audit Trails

Every user action within VarSeq and VSWarehouse is logged and attributed to authenticated individuals. Interpretations, classifications, and signed-out reports carry full user provenance.

Transmission Security

In air-gapped and firewall-mirrored deployments, patient data never traverses the public internet. All outbound connections support authenticated proxy routing.

Data Integrity

All analysis, interpretation, and reporting occurs within your institution's controlled environment. Workflow state saving ensures any past analysis can be reproduced exactly as it was run.

Regulatory Coverage

HIPAA Technical SafeguardsOn-premises architecture
GDPRData residency within jurisdictional boundaries
IVDR 2017/746CE marked VarSeq Dx for diagnostic use in the EEA
CAP / CLIAValidated templates and audit trails for accreditation
ISO 13485Certified quality management for medical device software
Pen-Tested
Validated Architecture

Built for Regulated Environments

Clinical genomics operates at the intersection of the most sensitive data categories and the strictest regulatory frameworks. Golden Helix is architected to meet these requirements without forcing trade-offs.

  • Separate VarSeq and VarSeq Dx software versions ensure clear research vs. diagnostic boundaries
  • Installation verification by Field Application Scientists before clinical use
  • Tiered proficiency certification program ensures analyst competency
  • Versioned annotation sources and locked-down pipelines for reproducible clinical results

Need Compliance Documentation?

Request security architecture details, certification documents, or a compliance review call.

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You Own Your Data. Period.

With Golden Helix, there is no shared tenancy, no vendor-hosted patient data, and no dependency on external cloud services to run your clinical workflows.

Cross-Border Data Protection

As genomic testing expands internationally, labs face increasing requirements to keep data within jurisdictional boundaries. On-premises deployment eliminates cross-border transfer concerns entirely.

“Multi-tenant SaaS platforms mean sharing security liability with your provider. Self-managed deployment puts your security team in full control of the perimeter.”
Platform
On-Prem, Private Cloud & Air-Gapped Deployment
Three deployment tiers with progressive security isolation

The Threat Landscape

Ransomware

Air-gapped systems are immune to network-delivered encryption attacks. No internet connection means no remote attack vector.

Data Exfiltration

On-premises deployment keeps patient data within your physical network boundary. No data traverses the public internet in any deployment tier.

Shared Tenancy Risk

Multi-tenant platforms expose you to your provider’s security posture. Self-managed deployment means your perimeter is yours to control.

Irreversible Exposure

Unlike compromised credentials, genomic data cannot be reissued. A breach of genetic information has permanent consequences for affected patients.

Enterprise Security Controls

Single Sign-On

Active Directory, SAML, and LDAP integration. Credentials are managed at the institutional level—passwords never leave your network. Complexity, rotation, and reuse policies follow your existing standards.

On-Premises Credentials

Workspace Isolation

Logical data separation for multi-group and multi-site deployments. Each clinical team operates independently within their workspace while sharing institutional knowledge through controlled catalogs.

Role-Based Access

Admin Dashboard

Centralized resource management and usage monitoring. Track active users, sample throughput, and storage consumption across your entire deployment from a single administrative interface.

Full Visibility

Compliance Insights & Webcasts

Regulatory guidance, IVDR transition strategies, and best practices for validating clinical genomics workflows.

On-Demand Webcasts

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Ready for Enterprise-Grade Security?

Join institutions worldwide that trust Golden Helix for secure, compliant clinical genomics infrastructure.

ISO 13485 Certified QMS
CE Marked (IVDR)
Air-Gapped Capable