Cognidox vs qmsWrapper

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.

qmsWrapper is a cloud eQMS for medical-device, SaMD, IVD, and growing manufacturer teams. Its Foundation, Lifecycle, and Vigilance levels allow organizations to add capabilities while keeping records and processes in one system. Foundation includes controlled forms and records, documents and approvals, training, tasks, and storage. Lifecycle adds workflows for CAPA, change control, deviations, nonconformities, feedback, suppliers, and risk. Vigilance covers post-market surveillance, Technical File visibility, and audit and regulatory evidence. AI can help complete forms, search documents, assess change impact, and support traceability, while authorized users review and approve regulated decisions. Jira projects and issues can connect to qmsWrapper, appear in its Traceability Matrix, and link to risks. The maker lists electronic signatures aligned with 21 CFR Part 11 and tamper-evident audit trails. It describes the service as pre-validated SaaS, but customers remain responsible for final validation for their intended use. EU and US hosting regions are available. Foundation costs €3,499 a year; a 14-day trial is available.