Qualityze CAPA Management

Spec sheet

Purpose

Manages corrective and preventive actions from initiation through closure, including investigation, action assignment, and effectiveness checks.Read 30 Sep 2026 · qualityze.com

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.Read 30 Sep 2026 · qualityze.com

Integrations

The pricing page says subscriptions include native ERP, LIMS, and third-party integrations.Read 30 Sep 2026 · qualityze.com

Security

The page describes SSO, MFA, and role-based access on its Salesforce-native architecture.Read 30 Sep 2026 · qualityze.com

Compliance

The product is described as supporting validated, 21 CFR Part 11-ready electronic records, electronic signatures, and a tamper-evident audit trail.Read 30 Sep 2026 · qualityze.com

Support

Every subscription includes dedicated support, software updates, validation packages, user guides, and onboarding.Read 30 Sep 2026 · qualityze.com

Headquarters

Tampa, Florida, USARead 28 Sep 2026 · qualityze.com

AI assistance

Q analyzes historical CAPA and related quality data to find similar issues, suggest next actions, and identify information gaps.Read 30 Sep 2026 · qualityze.com

Configuration

Workflows, forms, approvals, roles, and reports can be configured without code.Read 30 Sep 2026 · qualityze.com

Connected workflows

CAPA connects with audit, nonconformance, complaints, document control, training, supplier quality, incident, and change control processes.Read 30 Sep 2026 · qualityze.com

Effectiveness review

Configurable verification plans check whether actions addressed root causes and reduced recurrence before closure.Read 30 Sep 2026 · qualityze.com

Pricing

Qualityze provides an itemized quote based on the modules, users, sites, and services in the customer's scope.Read 30 Sep 2026 · qualityze.com

Regulatory frameworks

The CAPA data sheet lists ISO 9001, ISO 13485, QMSR, IATF 16949, AS9100, FDA, and GxP.Read 30 Sep 2026 · qualityze.com

Risk prioritization

Teams can assess impact with a risk matrix and Risk Priority Number, then prioritize CAPAs by risk.Read 30 Sep 2026 · qualityze.com

Root cause analysis

The product supports structured investigations with root cause tools such as the 5Why method.Read 30 Sep 2026 · qualityze.com

Plans and prices

Every Qualityze CAPA Management plan and price →

Where Specifiction places it

• Corrective and Preventive Action Software#19 of 236.8