AI root-cause analysis
A first-draft root cause and contributing factors, grounded in the nonconformity context.
Corrective & Preventive Action Software
CAPA Software for Provable, Closed-Loop Corrective Action
Turn every nonconformity into a tracked, verified, signed-off corrective action — not a spreadsheet that nobody closes. AI drafts the root cause and actions; you verify effectiveness and sign off with confidence.
From finding to closure, with evidence
A CAPA program only works if every action is investigated, actioned, verified and closed — and if you can prove it. ISOXPERT Compliance360 connects CAPAs to the NCRs, audits, incidents, complaints and risks that raised them, drafts a first-pass root-cause analysis and action plan with AI, and requires a 21 CFR Part 11 electronic signature before closure.
Key capabilities
The full corrective-action lifecycle, connected to where issues originate.
AI-suggested actions
Corrective and preventive action suggestions you review, edit and assign.
Multi-source intake
CAPAs raised from audits, NCRs, incidents, complaints, risks or KPI misses — one queue.
Verification of effectiveness
Track completion and record whether the action actually worked before closing.
Role-gated closure
State transitions and closure are gated to the right roles.
21 CFR Part 11 e-signature
A compliant electronic signature binds the closure to the record and audit trail.
How it works
- Raise a CAPA — from an audit finding, NCR, incident, complaint or risk.
- Investigate with AI — get a first-draft root-cause analysis to review and refine.
- Plan and assign actions — corrective and preventive actions with owners and due dates.
- Verify effectiveness — confirm the action worked before it can be closed.
- Sign off and close — a 21 CFR Part 11 electronic signature records who closed it, when and why.
Standards & frameworks
ISO 9001ISO 13485 / QMSRHACCPISO 2200021 CFR Part 11SMETAamfori BSCI
Why ISOXPERT Compliance360
- Closed-loop by design — CAPAs stay linked to the audit, NCR, incident or complaint that raised them.
- AI speeds investigation — a grounded first draft, not a blank page.
- Nothing closes without evidence — verification of effectiveness is a required step.
- Compliant sign-off — 21 CFR Part 11 electronic signatures with a full audit trail.
Frequently asked questions
What can trigger a CAPA?
Audit findings, NCRs, incidents, customer complaints, risk reviews or missed KPIs — all can raise a CAPA in ISOXPERT Compliance360.
Does the AI replace human root-cause analysis?
No — it drafts a starting point (e.g. a 5-whys style analysis) grounded in the nonconformity context, which your team reviews, edits and owns.
Is an electronic signature required to close a CAPA?
Yes. Closing a CAPA or its linked NCR requires a 21 CFR Part 11 electronic signature — you re-authenticate and state the reason for the sign-off, and it is recorded in a signature manifest.
Can I see CAPA trends and root-cause analytics?
Yes — CAPA Management includes a dashboard and analytics for status, source, type and root-cause breakdowns.
See it for yourself
One Platform. Unlimited Possibilities. Total Compliance.