Qualio
Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk.
With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive.
Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box.
Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand.
The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
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Guardz
Guardz is the unified cybersecurity platform built for MSPs. We consolidate the essential security controls, including identities, endpoints, email, awareness, and more, into one AI-native framework designed for operational efficiency.
With an identity-centric approach, an elite threat hunting team, and 24/7 AI + human-led MDR, Guardz transforms cybersecurity from reactive defense into proactive protection.
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cubeSAFETY
cubeSAFETY is a cutting-edge pharmacovigilance solution that aids safety teams in the effective management of adverse event reporting, regulatory submissions, and case processing while ensuring compliance. It complies with ICH E2B as well as various regional reporting guidelines, enabling submissions to regulatory bodies such as the FDA, EMA, CDE, MFDS, and PMDA through specialized gateways, and it can automatically convert and format data for CIOMS and XML exports. The platform features AI-enhanced medical coding recommendations, duplication detection, the ability to import CIOMS PDF files, and dynamic dashboards for tracking submissions in real-time. Furthermore, it provides seamless integration with other CRScube modules, including cubeCDMS. Designed to improve the safety case entry process, cubeSAFETY ensures exceptional data quality through built-in validation tools and streamlines workflows to meet global regulatory standards, all while reducing manual efforts and costs. In essence, this innovative platform aspires to transform the landscape of pharmacovigilance by enhancing both efficiency and accuracy in the industry, making it a valuable asset for safety teams worldwide.
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PvEdge
PvEdge represents a cutting-edge cloud-based software solution specifically designed for pharmacovigilance, offering thorough and compliant safety measures for pharmaceuticals, medical devices, vaccines, and their combinations. This innovative platform integrates a comprehensive safety database that simplifies the management of pharmacovigilance intake, case processing, submissions, AI-enhanced analytics, and safety signal detection, all within an intuitive interface. It is meticulously crafted to comply with both current and future regulatory requirements, such as 21 CFR Part 11, ANNEX 11, GxP, and GDPR, ensuring adherence to global standards. By leveraging advanced automation powered by AI and machine learning, PvEdge greatly enhances the efficiency of managing drug safety databases. Key features include automated literature reviews, rapid ICSR submissions, intelligent triage processes, automated signal detection, and efficient document automation. Moreover, the platform incorporates a controlled document management system that aids in the creation, management, and distribution of vital pharmacovigilance documentation, coupled with a risk-based enterprise quality management framework that promotes strong quality control practices and keeps detailed training records. Overall, these multifaceted capabilities position PvEdge as an essential asset for organizations dedicated to maintaining exemplary standards in drug safety while adapting to the evolving landscape of regulatory demands. As a result, it empowers businesses to operate more effectively and responsibly in their commitment to patient safety.
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