Qualio
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.
Learn more
AlisQI
AlisQI is a cloud-based quality management platform designed for process and batch manufacturers who want to move out of constant firefighting and into more stable, predictable operations, without losing control over compliance.
Instead of treating quality as a set of isolated documents or events, AlisQI connects quality, lab, and production data into a shared operational view. This allows teams across functions and sites to identify problems earlier, act faster when issues arise, and maintain confidence in both product quality and day-to-day execution.
The platform is organized around a set of configurable quality modules, including areas such as document control, training, deviation and CAPA management, audits, risk management, supplier quality, statistical process control, and EHS. On top of these modules, AlisQI provides ready-to-use solutions, called Solvers, which bring together forms, workflows, dashboards, and logic to address specific quality and operational challenges.
Solvers are designed to be usable from the start and to adapt over time as products, processes, or plants change. This evolution does not require custom development, external consultants, or disruptive IT projects, helping manufacturers improve without adding complexity.
Manufacturers use AlisQI to align quality practices across sites, reduce waste and rework, improve audit preparedness, support continuous improvement initiatives, and link shop-floor and lab data directly to quality processes. AlisQI is used across a wide range of manufacturing industries, including chemicals, plastics, paper and packaging, textiles, food and beverage, personal care, automotive, and industrial manufacturing.
Learn more
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
Learn more
Total Lean Management (TLM) Software
TLM QMS Software is a powerful and robust quality, risk and material management software (QMS) which is validated and 21 CFR Part 11 compliant. TLM is a cutting-edge, all-in-one quality management system that can be customized to integrate with online CRM software, QuickBooks or ERP databases.
Total Lean Management (TLM) QMS Software is specifically intended to be a low cost, highly integrated, flexible and continuously improving landscape to which specialty systems can be added where needed to create the digital business landscape that enables work flows the way your company needs them to work.
Learn more