Qualityze CAPA Management
Qualityze CAPA Management manages corrective and preventive actions from initiation to closure.
What Qualityze CAPA Management is
Qualityze CAPA Management manages corrective and preventive actions from initiation to closure. Teams can investigate issues, assign actions, and check their effectiveness before closing a CAPA. Risk matrices and Risk Priority Numbers help teams prioritize cases, while structured root-cause methods include 5 Whys, Fishbone, 8D, FMEA, PDCA, DMAIC, and A3. Configurable verification plans check whether actions addressed root causes and reduced recurrence.
The system links CAPA work with audits, nonconformance, complaints, document control, training, supplier quality, incidents, and change control. Its Q assistant analyzes historical CAPA and related quality data to find similar issues, suggest next actions, and surface information gaps. Workflows, forms, approvals, roles, and reports can be configured without code. The Salesforce-native architecture is described as supporting SSO, MFA, role-based access, validated electronic records, electronic signatures, and a tamper-evident audit trail. Pricing is by tailored quote; subscriptions include dedicated support, updates, validation packages, guides, onboarding, and integrations.
Good
- Risk matrix and Risk Priority Number prioritization
- Supports multiple structured root-cause methods
- Configurable effectiveness verification before closure
- Connects CAPA with related quality workflows
- Mobile access and electronic signatures are supported
Watch out
- No free plan
- Pricing is available by request only
- Tailored quote varies by modules, users, sites, and services
Who it suits
It suits quality leaders, CAPA coordinators, investigators, compliance teams, manufacturing operations, QA/QC and inspection teams, and supplier quality managers. It is aimed at organizations that need configurable corrective-action workflows tied to other quality processes.
Verdict
Qualityze CAPA Management brings investigation, risk prioritization, action tracking, and effectiveness review into connected quality workflows. Prospective customers need to request a quote, and the listed subscription support and integration details form part of that paid offering.
Plans and prices
From Qualityze CAPA Management's own pricing page, checked 30 Sep 2026.
| Plan | Price | What it gives you |
|---|---|---|
| Tailored quote | Priced on request | Pricing scales by modules, users, sites, and services |
The facts
Each one read from Qualityze CAPA Management's own pages, with the date it was checked.
What it does
- AI assistance
- Q analyzes historical CAPA and related quality data to find similar issues, suggest next actions, and identify information gaps.checked 30 Sep 2026
- Compliance
- The product is described as supporting validated, 21 CFR Part 11-ready electronic records, electronic signatures, and a tamper-evident audit trail.checked 30 Sep 2026
- Configuration
- Workflows, forms, approvals, roles, and reports can be configured without code.checked 30 Sep 2026
- Connected workflows
- CAPA connects with audit, nonconformance, complaints, document control, training, supplier quality, incident, and change control processes.checked 30 Sep 2026
- Effectiveness review
- Configurable verification plans check whether actions addressed root causes and reduced recurrence before closure.checked 30 Sep 2026
- Integrations
- The pricing page says subscriptions include native ERP, LIMS, and third-party integrations.checked 30 Sep 2026
- Intended users
- The product page identifies quality leaders, manufacturing operations, QA/QC and inspection teams, CAPA coordinators and investigators, compliance teams, and supplier quality managers.checked 30 Sep 2026
- Pricing
- Qualityze provides an itemized quote based on the modules, users, sites, and services in the customer's scope.checked 30 Sep 2026
- Purpose
- Manages corrective and preventive actions from initiation through closure, including investigation, action assignment, and effectiveness checks.checked 30 Sep 2026
- Regulatory frameworks
- The CAPA data sheet lists ISO 9001, ISO 13485, QMSR, IATF 16949, AS9100, FDA, and GxP.checked 30 Sep 2026
- Risk prioritization
- Teams can assess impact with a risk matrix and Risk Priority Number, then prioritize CAPAs by risk.checked 30 Sep 2026
- Root cause analysis
- The product supports structured investigations with root cause tools such as the 5Why method.checked 30 Sep 2026
- Security
- The page describes SSO, MFA, and role-based access on its Salesforce-native architecture.checked 30 Sep 2026
- Support
- Every subscription includes dedicated support, software updates, validation packages, user guides, and onboarding.checked 30 Sep 2026
The company
- Headquarters
- Tampa, Florida, USAchecked 28 Sep 2026
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