Cognidox vs MasterControl Quality Excellence

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.

MasterControl Quality Excellence has no write-up on Specifiction yet; its figures are above.