SOPs, training records and production history for medical device manufacturing — enforced where the work happens, not in a folder off-site.
Industry challenges
- Device history records are assembled manually
- Training and competency gaps create compliance risk
- Non-conformance tracking is slow and disconnected
- Audit trails across production and maintenance are incomplete
Compliance & audit requirements
Support ISO 13485-aligned workflows, GMP practices, internal audit programmes, and operator sign-off requirements with enforced digital processes.
How TraceSense helps
Enforced workflows, training linked to production, quality management and component-to-finished-device tracking — records you can show an auditor.