
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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Declarative Webhooks provides Salesforce users with an intuitive, declarative way to create bi-directional integrations between Salesforce and other external applications without writing any code. Similar to having Postman embedded within Salesforce, it offers a point-and-click interface that accelerates the integration process and improves efficiency. Fully integrated as a native Salesforce app, Declarative Webhooks leverages core platform tools like Flow, Process Builder, and Apex to enhance automation workflows. Users can easily set up webhook-based triggers and responses to synchronize data and events in real time. Additionally, the AI Integration Agent feature can automatically generate integration templates by analyzing provided API documentation URLs, reducing manual setup time. This capability simplifies complex API connections and helps users quickly deploy integrations. Declarative Webhooks is designed to empower admins and business users by removing technical barriers and boosting productivity. Its seamless fit within Salesforce ensures consistent and reliable integration experiences.
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ProductIP
Retail and trade companies are facing increasing scrutiny from customers, investors, NGOs, and regulatory bodies concerning product-related issues. Every day, there are concerns regarding product safety, the presence of banned substances, and energy consumption that fails to meet established standards. The landscape of regulations is growing ever more intricate, and as new technologies are introduced, products themselves are becoming more complicated. Failure to manage these challenges effectively may stifle growth and negatively impact financial outcomes. Therefore, it is essential for management to take control of these critical business aspects. ProductIP offers a Compliance Tracking System (CTS) designed to address these needs. By transforming complex regulatory data into an accessible, step-by-step process that begins with the product itself, companies can gain clarity. This approach enables businesses to ask the right questions of their suppliers and ensures that necessary documents are uploaded in an organized manner, rather than being exchanged haphazardly through emails. With such tools, companies can enhance compliance and streamline their operations.
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QT9 QMS
Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals.
QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations.
Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included.
Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com
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