SAP Responsible Design and Production 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.

Epicor Advanced Manufacturing Execution System is designed for plastic molders, manufacturers who use repetitive processes and those who have an assembly process that involves multiple machines. It is designed to assist floor operators in monitoring and optimizing their plant operations. Advanced MES helps manufacturers monitor their business and control it with real-time information on plant and machinery. The system allows users to identify inefficient allocations of resources to find new capacity for the business. It can also be used to record machine downtime, scrap and material waste in each production cycle. The software provides real-time monitoring of processes, scheduling in real time and visibility into operations. Users can view production details and descriptors and monitor up to 100,000 cycles. Maintenance teams can access machine condition reports for planning preventive maintenance. Advanced MES integrates accounting and manufacturing estimating capability.