cubeSAFETY 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.

OmegaCube has been revolutionizing the way businesses run their business since 1999 through technology adoption. OmegaCube ERP, its flagship product, is a unique enterprise resource management (ERP) solution that focuses exclusively on manufacturing and distribution. It serves the needs of aerospace, automotive, metal fabrication, electronics, and medical devices. The software was designed to automate workflows and help companies improve their operational efficiency. Our proprietary developer studio allows users to customize or extend the software, create their own applications, and incorporate unique business rules with minimal programming. It allows users to access ERP from any web browser and hand-held device from anywhere. The software can be hosted either on-premise or off premise. OmegaCube offers the necessary implementation expertise to ensure success. Our proven implementation method has helped companies of all sizes to realize their business vision.