Qualityze CAPA Management
- Android app
- Not listed
- Free plan
- No
- Runs on
- api, Web
Summary
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.
Who it is for
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.
What is 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
What to know first
- No free plan
- Pricing is available by request only
- Tailored quote varies by modules, users, sites, and services
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.
Qualityze CAPA Management plans and pricing
All plansCompared on corrective and preventive action software
- Free plan
- Noqualityze.com
- Root-cause methods
- 5 Whys, 5 Hows, Fishbone, Ishikawa, 8D, FMEA, PDCA, DMAIC, A3qualityze.com
- Effectiveness checks
- Yesqualityze.com
- Electronic signatures
- Yesqualityze.com
- Audit trail
- Yesqualityze.com
- Mobile access
- Yesqualityze.com
Facts
- Purpose
- Manages corrective and preventive actions from initiation through closure, including investigation, action assignment, and effectiveness checks.qualityze.com · 30 Sept 2026
- Risk prioritization
- Teams can assess impact with a risk matrix and Risk Priority Number, then prioritize CAPAs by risk.qualityze.com · 30 Sept 2026
- Root cause analysis
- The product supports structured investigations with root cause tools such as the 5Why method.qualityze.com · 30 Sept 2026
- Effectiveness review
- Configurable verification plans check whether actions addressed root causes and reduced recurrence before closure.qualityze.com · 30 Sept 2026
- Connected workflows
- CAPA connects with audit, nonconformance, complaints, document control, training, supplier quality, incident, and change control processes.qualityze.com · 30 Sept 2026
- AI assistance
- Q analyzes historical CAPA and related quality data to find similar issues, suggest next actions, and identify information gaps.qualityze.com · 30 Sept 2026
- Security
- The page describes SSO, MFA, and role-based access on its Salesforce-native architecture.qualityze.com · 30 Sept 2026
- Compliance
- The product is described as supporting validated, 21 CFR Part 11-ready electronic records, electronic signatures, and a tamper-evident audit trail.qualityze.com · 30 Sept 2026
- Regulatory frameworks
- The CAPA data sheet lists ISO 9001, ISO 13485, QMSR, IATF 16949, AS9100, FDA, and GxP.qualityze.com · 30 Sept 2026
- Configuration
- Workflows, forms, approvals, roles, and reports can be configured without code.qualityze.com · 30 Sept 2026
- Pricing
- Qualityze provides an itemized quote based on the modules, users, sites, and services in the customer's scope.qualityze.com · 30 Sept 2026
- Support
- Every subscription includes dedicated support, software updates, validation packages, user guides, and onboarding.qualityze.com · 30 Sept 2026
- Integrations
- The pricing page says subscriptions include native ERP, LIMS, and third-party integrations.qualityze.com · 30 Sept 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.qualityze.com · 30 Sept 2026
Company
- Headquarters
- Tampa, Florida, USAqualityze.com · 28 Sept 2026
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Sources
- qualityze.com/capa-management· checked 30 Sept 2026
- qualityze.com/pricing· checked 30 Sept 2026