Qualio
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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Nasdaq Metrio
Nasdaq Metrio is a sustainability reporting platform tailored for businesses at various stages of their ESG journey. It merges meticulous data collection, tracking, and management with emissions calculations and assurance. Additionally, it provides a comprehensive library of metrics from various rater and ranker frameworks as well as regulatory bodies, all cross-referenced, de-duplicated, and clarified, complete with guidance notes.
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ComplianceQuest
Natively built and operated on the Salesforce platform, QHSE is the fastest growing Enterprise Quality, Health and Safety Management System. Unified QHSE solutions combine EQMS with EHS to help customers of all sizes deliver high quality products and services in a safe and sustainable manner. They reduce risk, inefficiencies, and inefficiencies, while protecting their customers, employees, and brand.
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Assent
The Assent platform excels at intricately mapping out the multifaceted supply chains within manufacturing sectors such as aerospace and defense, automotive, electronics, industrial equipment, and medical devices. By overseeing suppliers, products, and components, we ensure that your offerings meet safety, compliance, and sustainability standards, covering everything from product compliance to ESG. Only Assent endeavors to chart the complete manufacturing genome, paving the way for genuine supply chain sustainability. With unparalleled insights into suppliers, products, and parts at the most granular level, your organization is empowered to lead, expand, and succeed in today's competitive landscape. Gain a comprehensive understanding of sustainability across your enterprise, pinpoint and address crucial challenges, and remain proactive with automatic regulatory updates, among other advantages. Assent uncovers hidden insights, affirms quality, and helps mitigate unexpected challenges. Our range of solutions, spanning from product compliance to ESG, enables the globe's most sustainable manufacturers to thrive in their respective markets. By partnering with Assent, you not only enhance compliance but also contribute positively to the environment and society.
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