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- Qualityze CAPA Management
On the recordRead 30 Sep 202615 facts
Qualityze CAPA Management
Tampa, Florida, USA
Plans and prices
Tailored quote
Priced on request
Pricing scales by modules, users, sites, and services
Read 30 Sep 2026 · qualityze.com
On the record
- AI assistance
- Q analyzes historical CAPA and related quality data to find similar issues, suggest next actions, and identify information gaps.qualityze.com · read 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.qualityze.com · read 30 Sep 2026
- Configuration
- Workflows, forms, approvals, roles, and reports can be configured without code.qualityze.com · read 30 Sep 2026
- Connected workflows
- CAPA connects with audit, nonconformance, complaints, document control, training, supplier quality, incident, and change control processes.qualityze.com · read 30 Sep 2026
- Effectiveness review
- Configurable verification plans check whether actions addressed root causes and reduced recurrence before closure.qualityze.com · read 30 Sep 2026
- Integrations
- The pricing page says subscriptions include native ERP, LIMS, and third-party integrations.qualityze.com · read 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.qualityze.com · read 30 Sep 2026
- Pricing
- Qualityze provides an itemized quote based on the modules, users, sites, and services in the customer's scope.qualityze.com · read 30 Sep 2026
- Purpose
- Manages corrective and preventive actions from initiation through closure, including investigation, action assignment, and effectiveness checks.qualityze.com · read 30 Sep 2026
- Regulatory frameworks
- The CAPA data sheet lists ISO 9001, ISO 13485, QMSR, IATF 16949, AS9100, FDA, and GxP.qualityze.com · read 30 Sep 2026
- Risk prioritization
- Teams can assess impact with a risk matrix and Risk Priority Number, then prioritize CAPAs by risk.qualityze.com · read 30 Sep 2026
- Root cause analysis
- The product supports structured investigations with root cause tools such as the 5Why method.qualityze.com · read 30 Sep 2026
- Security
- The page describes SSO, MFA, and role-based access on its Salesforce-native architecture.qualityze.com · read 30 Sep 2026
- Support
- Every subscription includes dedicated support, software updates, validation packages, user guides, and onboarding.qualityze.com · read 30 Sep 2026
