AI-Powered
QMS & CAPA Suite
Automate audits, close CAPAs faster, and drive continuous improvement, all from one unified quality platform.
Trusted by Industry Leaders
Core Modules
We are a passionate team of engineers, designers, and compliance experts dedicated to redefining quality management. Lena brings together audit, CAPA, and training management in one mobile-first, AI-driven platform, helping enterprises simplify processes, eliminate manual follow-ups, and ensure every task gets done right, the first time.
Audit & Inspection
Plan, perform, and close audits with guided checklists, smart findings, and auto-CAPA triggers that ensure nothing slips through.
CAPA Management
Record, analyze, and resolve corrective or preventive actions with built-in RCA fields, verification steps, and effectiveness checks.
Document & Training
Centralize version control, manage approvals, and assign training, keeping everyone aligned and audit-ready.
Vendor Quality
Score and accredit suppliers, manage site audits, and track non-conformances across your entire supply chain.
Mobile Operations
Work anywhere, even offline. Capture photos, signatures, and geolocation data with instant sync once back online.
Analytics & AI Insight
Monitor delays, KPIs, and visualize quality performance with real-time dashboards powered by AI.
Accelerate Quality Performance
Faster CAPA Closure
Less Paperwork
Faster Audits
Ready to Bring Intelligence to
Your Quality Operations?
See how SmartQMS handles the work that slows you down.
QMS / CAPA FAQs
Everything you need to know about automating audits, CAPAs, and compliance with Lena.
It reduces human error, improves traceability, and ensures every corrective and preventive action is verified on time.
Yes. QualityOps connects to your ERP, document management, and other tools. We handle the technical work so your data flows where it needs to go.
You keep it. We import your existing audits and CAPAs so nothing gets lost. Your history stays intact and searchable in the platform.
Absolutely. QualityOps meets FDA, ISO, and other regulatory requirements. Audit trails, role-based access, and encryption are built in.
Depends on your plan. Starter includes 5 users. Professional and Enterprise plans support unlimited users. Add or remove people whenever your team changes.