QT9 QMS vs Qualsmart

QT9 QMS is quality management software for regulated manufacturers, built to automate compliance and quality processes. It includes more than 28 modules, such as document control, audit and risk management, CAPA, inspections and supplier evaluations. Configurable workflows, approval controls, email alerts, reporting, timeline traceability and Excel exports support quality operations. Deployment can be cloud, on-premise or hybrid, with hosting in the U.S. and Europe. QT9 says the browser-accessed system needs no installation and works on PC, Mac and Linux. It describes the software as pre-validated with IQ/OQ/PQ and compliant with FDA 21 CFR Part 11, and lists support for ISO 13485, ISO 9001, EU MDR and AS9100. Security features listed include end-to-end encryption, two-factor authentication and role-based access; the maker also states 99.9% cloud uptime. QT9 QMS integrates with QT9 ERP and supports API connectivity. The company says it has served regulated manufacturers since 2005. Pricing is custom based on users and deployment requirements, and a free trial is available.

Qualsmart is cloud software organized into modules for quality management and food safety compliance. Smart Regulatory offers food regulation searches by country and commodity, alerts, and risk assessment models. Smart HACCP supports digital food safety plans, risk matrices, process flow diagrams, and CCP/PCP determination. Smart Lab manages sample workflows, customer portals, quotations, analysis planning, audit trails, electronic signatures, and lab assets. Smart Record provides a form builder with more than 36 field types, conditional rules, validations, and record traceability; its iOS and Android apps can create records offline and sync when connectivity returns. Other modules cover documents, suppliers, audits, compliance, specifications, environmental monitoring, training, recalls, corrective actions, visitors, and identity and access management. Smart Docs includes document workflows, version control, audit logs, search, and PDF export, and supports document controls aligned with 21 CFR Part 11. The company also describes IoT connections, blockchain-based supply-chain traceability, regional cloud hosting, and security controls including role-based access, SSO, and MFA. Qualsmart is available on the web, Android, iOS, and through an API. Pricing is on request.