Freedom251 › Corrective and Preventive Action Software
Qualityze CAPA Management
What Qualityze CAPA Management is
Qualityze CAPA Management handles corrective and preventive actions from initiation through investigation, assignment, effectiveness review, and closure. Teams can assess impact with a risk matrix and Risk Priority Number, then prioritize CAPAs by risk. Structured root-cause investigations support 5 Whys, 5 Hows, Fishbone, Ishikawa, 8D, FMEA, PDCA, DMAIC, and A3. Configurable verification plans check whether actions addressed root causes and reduced recurrence before closure. CAPA connects with audits, nonconformance, complaints, document control, training, supplier quality, incidents, and change control. The Q assistant analyzes historical CAPA and related quality data to find similar issues, suggest next actions, and identify information gaps. Workflows, forms, approvals, roles, and reports can be configured without code. Qualityze describes SSO, MFA, role-based access, validated electronic records, electronic signatures, and a tamper-evident audit trail. Web, API, and mobile access are listed. Pricing is on request.
Who it suits
It suits quality leaders, manufacturing operations, QA/QC and inspection teams, CAPA coordinators, compliance teams, and supplier quality managers. Organizations needing configurable regulated workflows may also consider it.
What it does well
- Risk matrix and Risk Priority Number prioritization
- Multiple structured root-cause methods
- Configurable effectiveness verification plans
- Connected quality and change workflows
- Electronic signatures and tamper-evident audit trail
What to know first
- No free plan
- Pricing is available only by tailored quote
- Configuration is centered on Salesforce-native architecture
- Regulatory readiness is described, not a stated certification
Limits
There is no free plan. Pricing is provided through a tailored quote that scales with the selected modules, users, sites, and services.
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| Tailored quote | Pricing scales by modules, users, sites, and services | On request |
As qualityze.com lists them, read 30 Sept 2026. The maker's own page has the final word.
Getting started
- Open the Qualityze CAPA Management website
- Request an itemized quote based on modules, users, sites, and services
- Select the quality processes and integrations required
- Configure workflows, forms, approvals, roles, and reports without code
- Use included onboarding, guides, validation packages, and dedicated support
- Access the system through its web, API, and mobile options
Verdict
Qualityze combines CAPA investigation, risk prioritization, connected quality processes, and configurable controls. Its tailored pricing and regulated-workflow focus make scope and implementation details important before adoption.
Questions
How is Qualityze CAPA Management priced?
Qualityze provides an itemized quote based on the modules, users, sites, and services in the customer’s scope.
Is there a free plan?
No. The product is paid and has no free plan.
What root-cause methods are supported?
Methods include 5 Whys, 5 Hows, Fishbone, Ishikawa, 8D, FMEA, PDCA, DMAIC, and A3.
Does it include electronic signatures and audit trails?
Yes. The product is described as supporting electronic signatures and a tamper-evident audit trail.
What integrations are included?
Subscriptions include native ERP, LIMS, and third-party integrations, and CAPA connects with several quality processes.
Facts from Qualityze CAPA Management's own pages
- 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
- 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
- Configuration
- Workflows, forms, approvals, roles, and reports can be configured without code. · 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
- Effectiveness review
- Configurable verification plans check whether actions addressed root causes and reduced recurrence before closure. · qualityze.com, 30 Sept 2026
- Headquarters
- Tampa, Florida, USA · qualityze.com, 28 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
- Pricing
- Qualityze provides an itemized quote based on the modules, users, sites, and services in the customer's scope. · qualityze.com, 30 Sept 2026
- Purpose
- Manages corrective and preventive actions from initiation through closure, including investigation, action assignment, and effectiveness checks. · 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
- 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
- Security
- The page describes SSO, MFA, and role-based access on its Salesforce-native architecture. · qualityze.com, 30 Sept 2026
- Support
- Every subscription includes dedicated support, software updates, validation packages, user guides, and onboarding. · qualityze.com, 30 Sept 2026