
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.
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The SBS QMS Suite consists of 5 software modules that work together for efficient Quality compliance:
1) SBS Quality Database
- CAPA / 8D corrective and preventive actions (CAR) with root cause analysis
- Nonconformance management
- Risk analysis including FMEA, SWOT, interested party risk register
- Internal, customer, and third-party audit management
- Environmental Health and Safety (EHS / HSE) management
2) SBS Ground Control
- Employee training management (LMS)
- Self-Paced training
- Change control
- Document control
3) SBS Asset Tracking Database
- Calibrated equipment control
- Preventive maintenance
- Asset inventory management
4) SBS Inspection Database
- Record incoming material, in process, and final product inspection data
- Generate real time SPC charts
- Inspection plans and Control Plans
- Archive data for further statistical analysis
5) SBS Vendor Management
- Maintain an approved vendor list or AVL
- Develop vendor / supplier qualification plans
- Maintain vendor / supplier qualification history
Modules may be purchased separately or in any combination.
On-premise and cloud-based options are available.
Free demos are available for download or contact us for a cloud-based demo.
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Lumafield
Lumafield's X-ray computed tomography system provides unparalleled insights into objects, revealing features that were previously hidden. With its innovative Neptune CT scanner, which is user-friendly and complemented by the Voyager cloud-based software, Lumafield removes the hassle from inspection processes, addressing challenges from the design phase all the way to mass production. This Neptune scanner is an essential tool for engineering teams, suitable for both offices and workshops, featuring an intuitive, AI-enhanced interface that enables anyone to conduct scans effortlessly. The Voyager software transforms these scans into measurable and actionable data, allowing users to visualize, analyze, and share insights in real-time simply through a web browser. Additionally, Lumafield's platform is ready for automation, facilitating comprehensive CT inspections on high-volume production lines, which enables thorough examination of every manufactured part, ensuring quality control and enhancing supply chain management. By fully integrating this technology into your workflow, you gain a competitive edge in maintaining product excellence.
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PC-DMIS
PC-DMIS stands out as a premier, all-encompassing metrology software solution that empowers users to design and implement accurate measurement workflows, oversee dimensional inspection data, and collaborate on findings to enhance quality assurance in both design and manufacturing sectors; its adaptable architecture accommodates a diverse array of measurement systems, such as stationary CMMs, portable arms, laser trackers, and multisensor probes, all while maintaining a cohesive user experience across different devices, allowing operators and programmers to interact seamlessly with the same interface irrespective of the hardware used. The software encompasses a robust geometric dimensioning and tolerancing toolkit, sophisticated measurement algorithms, and offline programming capabilities, which allow for the development of routines without monopolizing machine time. Additionally, it offers specialized modules designed for particular applications, including vision metrology, gear inspection, blade scanning, and in-process measurement for CNC machines, further enhancing its versatility and efficiency in various industrial contexts. This comprehensive suite of features makes PC-DMIS an invaluable asset for organizations committed to maintaining high standards of quality and precision in their operations.
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