Cognidox vs QT9 QMS

Cognidox is a document and quality management platform for product development teams, including businesses in medical devices, life sciences, and high tech. It organizes controlled documents with versioning, change management, audit trails, metadata indexing, e-signatures, and configurable approvals. For design controls, teams can set phase gates, validate designs, and assemble FDA technical documentation such as DHF, DHR, and DMR. Quality workflows cover CAPA and OFI, supplier management, complaints, non-conformance reports, and post-market surveillance. A learning management system adds skills matrices, self sign-off, quizzes, trainer assessment, and tracking of skill gaps. Cognidox describes support for ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 11 requirements. Its event log records timestamped actions that cannot be changed or removed, while user IDs, passwords, and configurable rights govern access. Plans start from £6,000/yr, with a 14-day supported trial; there is no free plan. The service is available on web, Windows, and API, with no mobile apps listed.

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.