Version Control & Audit Trail in Matrix eIFU
Every change to an IFU document is tracked, timestamped, and traceable — giving manufacturers the regulatory confidence they need across the full product lifecycle.
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The challenge
Proving control over IFU changes is hard without a structured system
- No single record of changeWithout version control, it is difficult to show a notified body exactly what changed, when, and why.
- Manual archiving is error-proneTracking superseded IFU versions by hand risks the wrong version staying live.
- Audit evidence takes too long to produceReconstructing a document's history for an inspection can take days of manual digging.
Our solution
A complete, timestamped history of every IFU version
- Full version historyEvery change is recorded with a timestamp and change record, automatically.
- Role-based approval before publishingNew versions only go live once the required approvals are complete.
- Audit trail on demandLogs are accessible instantly for regulatory inspections and notified body audits.
Core capabilities
Full traceability on every IFU document, from first version to latest.
Full version history
Every change to an IFU document is tracked with a timestamped change record.
Timestamped change records for every edit
Comparison view between IFU versions
Retention of historical versions per EU MDR and FDA requirements
Role-based approval workflows
New IFU versions only go live once the required approvals are complete.
Configurable approval roles before publishing
Automatic archiving of superseded versions
Notification when versions are updated
Inspection-ready audit trail
Every action is logged and accessible for regulatory inspections and notified body audits.
Audit trail logs ready for inspection
Supports ISO 13485 and MDR technical file maintenance
Zero manual record keeping
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