Arena QMS Reviews

Epicor Connected Process Control provides a simple-to-use software solution that allows you to configure digital work instructions and enforce process control. It also ensures that operations are error-proof. Connect IoT devices to collect 100% time studies and process data, images and images at the task level. Real-time visibility and quality control on a new level! eFlex can handle any number of product variations or thousands of parts, whether you are a component-based or model-based manufacturer. Work instructions can be linked to Bill of Materials, ensuring that products are built correctly every time, even if changes are made during the process. Work instructions that are part a system that is advanced will automatically react to model and component variations and only display the right work instructions for what's currently being built at station.

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.