
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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Onspring
The GRC software you've been looking for: Onspring. A flexible, no-code, cloud-based platform, ranked #1 in GRC delivery for 5 years running.
Easily manage and share information for risk-based decision-making, monitor risk evaluations and remediation results in real-time, and create reports with with KPIs and single-clicks into details.
Whether leaving an existing platform or implementing GRC software for the first time, Onspring has the technology, transparency, and service-minded approach you need to achieve your goals rapidly.
Our ready-made product products are designed to get you going as fast as 30 days.
SOC, SOX, NIST, ISO, CMMC, NERC, HIPAA, PCI, GDPR, CCPA - name any regulation, framework, or standard, and you can capture, test, and report on controls and then activate remediation of risk findings.
Onspring customers love the no-code platform because they can make changes on the fly and build new workflows or reports in minutes, all on their own without the need for IT or developers. When you need nimble, flexible, and fast, Onspring is the best software option on the market.
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LogicGate Risk Cloud
Risk Cloud™, LogicGate's most popular GRC process automation platform Risk Cloud™, allows organizations to transform disorganized compliance and risk operations into agile process apps without having to write a single line code.
LogicGate believes that enterprise technology can make a significant difference in the lives of employees and their organizations. We aim to transform the way companies manage governance, risk, compliance (GRC), programs so that they can manage risk with confidence. LogicGate's Risk Cloud platform, cloud-based applications, and raving fan service, combined with expertly crafted content, allow organizations to transform disorganized compliance operations into agile processes without writing a line of code.
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