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For emerging biotech companies, success depends on moving fast without compromising compliance. Yet many traditional Quality Management Systems (QMS) are slow to implement, hard to customize, and frustrating to use—adding friction at the very moment agility is most critical. 

Helyx Quality offers a modern alternative: a modular, cloud-based QMS purpose-built for life sciences innovators. 

Quality Is Evolving—Your QMS Should Too  

Legacy QMS platforms were designed for centralized teams and on-premise infrastructure. In contrast, today’s companies are distributed, timelines are compressed, and expectations around data integrity, training traceability, and audit readiness have intensified. 

Helyx Quality aligns with this shift, enabling speed, adaptability, and visibility—without sacrificing compliance. 

What Makes Helyx Quality Different? 

Unified Platform for the Full Quality Lifecycle  

• Seamlessly connects document control, training, and compliance in real time 
• 21 CFR Part 11-compliant from day one 
• Built for inspection readiness and traceability 

 
Document Control Designed for Modern Teams 

• Real-time O365 collaboration and automated workflows 
• Delegation, version comparison, and audit trails built in 
• AES-256 encryption and role-based access for security 
• Fully validated for 21 CFR Part 11, and ISO standards 

Integrated Training That Keeps Up with Change 

• Auto-generates training when SOPs or documents are updated 
• Role-based learning paths tied to job titles and compliance needs 
• Multimedia support and SCORM compliance 
• Auto-reminders for retraining and certification lapses 
• Full auditability with linked quality workflows 

Configurable Without Custom Code 

• No-code setup allows teams to configure workflows, training, and document types 
• Eliminates reliance on consultants, accelerating adoption and ownership 

Enterprise-Grade Security and Scale 

• Pre-validated for regulatory use 
• Built on secure, cloud-native infrastructure 
• Global scalability and disaster recovery included 
• Direct support from quality and technical experts 

A Roadmap Aligned with Biotech Needs 

• Helyx Quality is rapidly evolving to include additional core modules—such as Change Control, CAPA, and Deviations 
• These upcoming features will seamlessly integrate with existing workflows, providing a single, connected quality system 
• Designed to grow with your team and compliance requirements, without replatforming. 

Designed for Biotech’s Pace  

Whether preparing an IND, scaling through clinical trials, or facing inspection, Helyx Quality adapts to your journey. Deployment takes as little as 4–6 weeks and supports FDA readiness, ISO certification, and investor due diligence. 

The Strategic Case for Change  

Choosing the right QMS isn’t just an IT decision—it’s a growth strategy. By eliminating inefficiencies in core quality workflows, Helyx Quality helps teams accelerate milestones, stay audit-ready, and demonstrate operational maturity. 

In today’s funding and regulatory environment, that’s a competitive edge. 

Conclusion: A Platform Built for Builders  

Helyx Quality was designed by quality and regulatory experts who understand the realities of scaling biotech organizations. Whether you’re launching your first IND or preparing for commercialization, Helyx is more than a compliance system—it’s a partner for what’s next. 

Learn more at: helyxtech.com/product/helyx-quality
Or contact: sales@helyxtech.com