
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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Certainty Software
Certainty is an enterprise-level auditing and inspection software that can be trusted to help you manage and report on business risk, compliance, and performance metrics quickly and efficiently.
Certainty Software is used by hundreds of thousands of professionals to complete millions of inspections and audits each year. It provides all the tools you need to collect, collate, and report consistent, accurate, and meaningful metrics across your business.
Certainty provides all the tools you need to design, manage, and report on audit/inspection data, as well as help you manage and mitigate any risks, incidents, and issues that may be identified during the audit/inspection process.
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FastField Forms
As a leader in enterprise mobile forms software, FastField empowers organizations with all the tools necessary to quickly collect accurate and meaningful data from a mobile workforce. We offer a simple and intuitive website and mobile app that are accessible across iOS and Android. FastField is flexible and dynamic, capable of complete customization and full automation of your form collection workflow. Our focus is business intelligence, transforming your forms into meaningful data that helps you make informed decisions for your business.
• Simple / Intuitive UI for Mobile and Web
• Extreme Flexibility For Any User / Use Cases
• Highly Customizable Forms Workflow
• Robust Offline/Online Data Capture Support
• Fully Integrated Data Analytics Platform With Automated Custom Alerts
• Full Multi-Media Capture Support With Annotation and Comment Capabilities
• Enterprise Level Integration Support: Cloud Storage or Private Data Delivery
• Application Branding (White Label Solutions)
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ReachOut Suite
ReachOut Suite, a cloud-based field service management software that allows service companies to coordinate and optimize their entire field operations, is available for free. ReachOut is easy to use and has many features that allow field service technicians and managers to do their jobs more efficiently and faster. Smart mobile-optimized forms make it easy to digitize field service operations. For audits or inspections, you can quickly and accurately gather data. ReachOut makes it easy to record customer requests and send technicians the shortest routes. You can track progress in real time, track the progress of work, generate professional-looking invoices right away, and more.
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