
Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness.
Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards.
Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams.
Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations.
The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.
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HSI Donesafe redefines EHS management with a no-code, cloud-based platform that transforms complex processes into streamlined, user-friendly workflows. Trusted across industries, Donesafe consolidates tracking, management, and reporting into one accessible platform, making compliance simpler and safety more effective.
Donesafe’s adaptable design allows teams to customize workflows, forms, and dashboards to meet evolving compliance needs. With tools for incident reporting, audits, training, and risk assessment, staying ahead of regulatory changes has never been easier.
Key Features:
- Customizable workflows to align with regulations
- Real-time insights for live safety tracking
- Scalable design that grows with your team
- Streamlined compliance tools for smooth audits and reporting
Empower your EHS team to achieve safety excellence with HSI Donesafe.
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Compliance Builder
Compliance Builder™, a real-time monitoring tool, is designed to enable 21 CFR Part 11 compliance. It provides data integrity across IT systems such file systems, laboratory and manufacturing instruments, as well as providing file system, database, laboratory, and manufacturing instrument data integrity. Compliance Builder allows you secure track all IT subsystems, including file systems, databases and laboratory equipment. It can be set up to monitor any file-based system, including file modifications and additions.
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EHS Insight
EHS Insight, an EHS management platform, empowers organizations to ensure compliance across the company. EHS Insight is affordable and easy to set up. It provides businesses with all the tools they need for managing incidents, audits, inspections, compliance obligations and corrective actions. EHS Insight offers exceptional support for businesses both during and after the software implementation.
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