Cognidox vs FlinkISO

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.

FlinkISO is open-source quality management software for handling documents, forms, workflows and QMS records. It supports ISO 9001, ISO 14001, ISO 45001 and ISO 13485, with other standards configurable. Document tools include search, retrieval, version control, access restrictions and approval workflows. Users can make HTML forms with drag-and-drop fields, validations, layouts and business rules without coding. Modules cover audits, change control, management reviews, complaints, nonconformities, corrective actions, training, equipment records and calibration. FlinkISO integrates with ONLYOFFICE for document editing and approval, and can connect to cloud OpenAI-compatible providers or self-hosted Ollama for chat and form-building workflows. Install it on Linux or Windows servers, or use the hosted edition. The Free On-Premise plan is free, with no expiry and all QMS modules. On-Cloud QMS and Form Creation API each cost $80 a month; hosted file uploads are limited to 25 MB each. The Startup Plan is $750 as a one-time purchase for a three-month plan.