Quality management that teams actually enjoy
Unify document control, training, CAPA, and audits in one validated system—with real-time audit trail and AI-assisted workflows.
- Part 11–ready
- ISO 13485
- Traceability
- Automated assignments
All your documents, all in one place
Version history, approvals, watermarks, and real-time audit trail. Route documents automatically and unlock instant training assignments.
- Granular permissions & check-in/out
- Templated workflows & e-signatures
- Auto-training on release
CAPA, end-to-end
From intake to effectiveness checks, with AI-assisted root cause suggestions and duplicate detection.
Training that keeps pace
Auto-assign training on release, track effectiveness, and requalify at change.
Supplier quality, integrated
Scorecards, qualifications, and linked nonconformances help you manage risk across your supply chain.
Design Controls that connect to reality
Keep DHF/DMR synchronized with changes, risks, and verification results.
How it works
Glance at what we do!
99.9%+availability
Minutesto create a route
Real-timeaudit trail
See Akunyx in action
We’ll tailor a walkthrough to your current processes.