Matrix eIFU for FDA eLabeling (US)
A flexible, validated platform to meet current and emerging FDA eLabeling requirements as the FDA continues to modernise its labelling regulations.
For taking a demo with our team.
The challenge
Electronic labelling under 21 CFR Part 801 comes with strict conditions
- Persistent, accessible URLs requiredLabelling must be accessible at a specific URL referenced on the device or packaging.
- Paper must remain availablePaper labelling must be available upon request, just as under EU eIFU rules.
- Records must meet Part 11Electronic records need to satisfy 21 CFR Part 11 requirements.
Our solution
A validated platform built for FDA eLabeling compliance
- 21 CFR Part 11 compliantCompliant hosting and access controls out of the box.
- Stable, persistent URLseLabel URLs remain stable for reference on device packaging.
- GUDID-ready UDI supportSupport for FDA UDI linkage via GUDID.
How Matrix eIFU supports FDA eLabeling
Built for US manufacturers reducing paper labelling costs.
Part 11 compliant hosting
Hosting and access controls built to meet FDA electronic record expectations.
21 CFR Part 11 compliant hosting and access controls
Stable, persistent eLabel URLs referenced on device packaging
Support for FDA UDI linkage via GUDID
Paper obligation covered
International paper-on-demand fulfilment keeps you compliant with FDA conditions.
International paper on demand fulfilment
Version control and audit trail for FDA record keeping
Documentation package to support computer system validation
Built for US manufacturers
Reduce paper labelling costs and improve supply chain flexibility.
Reduces paper labelling costs
Improves supply chain flexibility
Meets current FDA eLabeling guidance
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