Streamline Verify Reviews

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.

Captain Compliance is a privacy management platform that simplifies compliance with global data protection legislation and new AI regulatory requirements. Our Consent Management Platform allows businesses to easily manage user consent, and create customized cookie banners. Our advanced Cookie Scanner automatically detects and categorizes all cookies on your site, ensuring compliance with a dynamic policy. Our DSAR Portal streamlines requests from data subjects, while our AI Compliance Tool monitors and adapts to evolving regulations. We even offer a virtual DPO or CPO if data privacy guidance is needed. Our Hosted Privacy Policy Generator automatically updates your privacy policies in real-time to ensure that they are always up-to date with the latest legal requirements. Captain Compliance offers you the tools to maintain regulatory compliance and protect user data at an affordable price.