Helyx Quality
Helyx simplifies compliance by integrating document management, training, change controls, deviations, and CAPAs into a single, cloud-based solution. By combining Helyx Controlled Documents, Helyx User Learning, and Helyx Quality Management System, it streamlines workflows, ensures regulatory alignment, and keeps teams always audit-ready.
Powered by Microsoft Azure, Helyx is pre-validated for 21 CFR Part 11, GxP, GDPR, and HIPAA, offering secure, scalable, and cost-effective quality management for biotech and pharma companies—accelerating compliance without slowing innovation.
Helyx Controlled Documents streamlines document management while ensuring full traceability and compliance, helping life sciences companies improve efficiency and regulatory readiness. Pre-configured workflows, fast deployment, modular design and scalable pricing makes it cost-effective for early-stage and mid-sized biotechs, while seamless integration with Helyx User Learning ensures unified compliance.
Learn More →Helyx User Learning module simplifies training management with end-to-end training content creation, third-party content support, and compliance reporting. This module seamlessly integrates with the Helyx Controlled Documents Module to provide consistent compliance and easily accessible content across your organization.
Learn More →Helyx QMS integrates quality processes for Change Controls, Incidents, Deviations, and CAPAs and ensures full traceability across processes and compliance, helping lifecycles companies identify and resolve non-conformities and prevent their recurrences. Automated workflows with reviews and sign-offs along with the capabilities to plan, assess and implement changes, corrective and preventive actions consistently across your organization.
Learn More →Explore Helyx's features, benefits, and how it can drive your success.
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