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Company description

Qualio is a cloud-based quality and compliance software platform purpose-built for growing life science companies. It unites quality management, product lifecycle management, and compliance intelligence in a single integrated solution, enabling organizations to stay continuously audit-ready and accelerate their path to market. Qualio serves a broad range of highly regulated industries, including medical devices, pharmaceuticals, biotech, cannabis, Software as a Medical Device (SaMD), and contract research organizations (CROs), and is trusted by over 700 customers across the globe.

The platform addresses the increasing complexity of regulatory demands by combining AI-powered gap analysis, cross-mapped evidence, and continuous compliance monitoring. Qualio helps companies reduce audit preparation time from 20+ weeks to fewer than 4, delivering an 80% reduction in audit prep time, a 5x ROI within 2 months, and a 60% reduction in consultant spend.

Compliance Intelligence

• Automates gap analysis across 28+ regulatory standards, including FDA, ISO 13485, EMA, and MDR frameworks
• Enables cross-mapping of evidence once, with reuse across multiple submissions and markets
• Provides real-time risk alerts to proactively address compliance issues
• Delivers board-ready dashboards for executive visibility into compliance status
• Supports confident expansion into new markets by maintaining continuous audit readiness

Quality Management Capabilities

• Full electronic Quality Management System (eQMS) functionality designed for the entire life science ecosystem
• Supports medical device companies in streamlining a fast, safe pathway to market while maintaining compliance
• Embeds industry-leading pharmaceutical quality processes to simplify FDA, ISO, and ICH compliance
• Enables biotech companies to build quality-centric products that satisfy regulators, patients, and stakeholders
• Provides cannabis companies with a robust, quality-first approach to earn regulatory trust and support business growth
• Offers end-to-end product lifecycle control for Software as a Medical Device teams
• Helps contract research organizations deliver compliant, continuously improving services

Platform Validation and Implementation

• Qualio's validation approach is built around the latest FDA and GAMP industry guidelines
• Pre-built templates and automated document packs accelerate or eliminate validation tasks
• Customers go live up to 2 weeks faster than with traditional eQMS validation methods
• Only 1% of customers choose to validate the system themselves, reflecting the ease of Qualio's managed validation process
• Rapid implementation timelines — one customer went live within weeks of signing and achieved ISO 13485 certification within months

Regulatory Standards Supported

• Covers 28+ regulatory frameworks including FDA regulations, ISO 13485, EU MDR, ICH guidelines, and EMA standards
• Designed to support compliance across multiple geographies simultaneously, enabling global market entry

Notable Customer Outcomes

• Customers report significant time savings, with one VP of IT noting the equivalent of gaining a full-time employee through hours recovered
• Teams have successfully completed demanding audits using Qualio's smart linking and seamless process navigation
• Customers highlight ease of use, rapid onboarding, and strong implementation support as key differentiators
• Qualio is recognized for offering an accessible, modern interface compared to legacy eQMS providers
• Cost of licensing is frequently cited as insignificant compared to process improvement savings achieved

Qualio is recognized as the number one cloud-based quality management software for life science companies seeking a scalable, integrated, and continuously audit-ready compliance platform. Its combination of intelligent automation, rapid deployment, and broad regulatory coverage makes it a compelling choice for startups and growing organizations navigating complex global regulatory environments.

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Software attributed to Qualio

• QMSView
• Design ControlsView
• Change ControlView
• Pharmacovigilance & Post-Market SurveillanceView

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