Compliance, Simplified. Innovation, Accelerated.

The Business Problems We Solve

Life sciences compliance is complex, and outdated systems make it worse. Manual processes, disconnected tools, and security risks create inefficiencies and slow operations.

Document Bottlenecks - Manual approvals and outdated workflows delay regulatory submissions.
Training Gaps - SOP updates outpace training, increasing compliance risks.
Data Security Risks - Legacy file-sharing methods expose sensitive data when collaborating with CROs, CDMOs and partners.
High-Cost, Disjointed Systems - Lack of integration leads to inefficiencies and rising costs.

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Helyx delivers a fully integrated ecosystem for managing compliance, training, controlled documents, and data collaboration.

Helyx Quality - Compliance without the complexity

Helyx Controlled Documents - Secure, Compliant, and Always Audit-Ready

Managing SOPs, batch records, and regulatory documents has never been easier.

Automated Version Control: Maintain full traceability of every document change.
Pre-Configured Workflows: Eliminate manual approvals and ensure compliance.
Audit-Ready Documentation: Built-in audit trails for effortless inspections.
Granular Role-Based Access: Ensure only authorized users can access critical files.

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Helyx Learning - Training that adapts to your team

Helyx User Learning - Training That Adapts to Your Team

Automating role-based training, ensuring employees stay current with compliance requirements.

Automated Training Assignments: No more manual tracking.
Role-Based Learning Paths: Employees receive relevant, job-specific training.
Real-Time Progress Tracking: Managers have full visibility into completion.
Audit-Ready Certifications: Maintain training logs for audits and inspections.

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Helyx Data

Helyx Data - Secure, Compliant, and Audit-Ready Data Collaboration

Helyx Data keeps sensitive data secure, compliant, and accessible in real time from clinical trial results to manufacturing records.

Encrypted Data Sharing: Share regulatory reports and clinical data securely.
Real-Time Security Monitoring: Protect sensitive data with MFA and malware detection.
External Collaboration Without Extra Licensing: Invite partners without added license costs.
Seamless Microsoft 365 Integration: Collaborate with version control and audit trails.

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The Helyx Advantage

Purpose-Built for Life Sciences

Unlike generic document and training systems that require expensive customization, Helyx products come pre-configured for biotech and pharma organizations with industry-compliant workflows—eliminating the need for costly modifications.

Pre-Validated for Adherence & Audits

Most platforms require extensive validation efforts before use. Helyx products come pre-validated for 21 CFR Part 11 making them audit-ready from day one and saving companies significant compliance costs.

Lower Total Cost of Ownership

Helyx provides enterprise-grade capabilities at a fraction of the cost of traditional systems by leveraging Microsoft Azure as the foundation, pre-validated compliance packages to eliminate costly validation cycles, and automating deployment.

Unified Platform Approach

While competitors specialize in either quality management, training, regulatory submissions, or data sharing, Helyx integrates all four functions into a single ecosystem. This approach improves users’ experience by reducing complexity and eliminating data silos.

Seamless Microsoft Integration

Traditional QMS and document systems rely on rigid workflows that slow down reviews. Helyx integrates directly with Microsoft 365, enabling real-time, multi-user editing of controlled documents while maintaining full version control and audit trails.

Rapid Deployment – Ready in Weeks

While legacy QMS or eTMF solutions require lengthy setup cycles, Helyx products can be fully operational within weeks thanks to cloud-based deployment on Microsoft Azure, pre-configured workflows, and automated setup processes.

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Explore Helyx's features, benefits, and how it can drive your success.

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