Cognidox vs Qualsmart

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.

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.