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Life sciences compliance is complex, and outdated systems make it worse.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- Document Bottlenecks – Manual approvals and outdated workflows delay regulatory submissions.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.
Helyx automates compliance, streamlining document control, training, and data collaboration for seamless, audit-ready operations.
EXPLORE HELYX SOLUTIONS
Helyx delivers a fully integrated ecosystem for managing compliance, training, controlled documents, and data collaboration.
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 regulatory inspections.
- Granular Role-Based Access: Ensure only authorized users can access and modify critical files.
- Seamless Collaboration: Work in real-time with internal teams and external partners.
Helyx User Learning - Training That Adapts to Your Team
Automating role-based training, ensuring employees are always up to date with the latest compliance requirements.
- Automated Training Assignments: No more manual tracking—training updates automatically.
- Role-Based Learning Paths: Employees receive only relevant, job-specific training.
- Real-Time Progress Tracking: Managers have full visibility into training completion.
- Integrated Document Links: Training materials are always linked to the latest approved versions.
- Audit-Ready Certifications: Maintain training logs for regulatory audits and inspections.
Helyx Data - Secure, Compliant, and Audit-Ready Data Collaboration
Helyx Data ensures your sensitive data from clinical trial results to manufacturing records remains secure, compliant, and accessible in real-time.
- Encrypted Data Sharing: Share regulatory reports, batch records, and clinical trial data via secure virtual data rooms.
- Real-Time Security Monitoring: Protect sensitive data with continuous malware detection and multi-factor authentication.
- External Collaboration Without Extra Licensing: Invite partners (CROs, CDMOs) without additional license costs.
- Cloud-Based Storage: Archive research, quality, and regulatory data with on-demand access.
- Integrated Compliance: Pre-validated for 21 CFR Part 11, GDPR, and HIPAA from day one.
- Seamless Microsoft 365 Integration: Collaborate in real time with built-in version control and audit trails.
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, GxP, GDPR, and HIPAA, 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.