Qualtate
AI-Native E-QMS Platform

AI-Native E-QMS for Modern Quality Management

Transform your quality management with intelligent automation. Update reports in seconds, ensure FDA compliance, and streamline operations with our cutting-edge AI platform.

Reduce manual effort

Ensure 100% FDA compliance

Real-time quality insights

Seamless API integrations

Let engineers focus on innovation

Powerful AI-Driven Features

Streamline your quality management processes with intelligent automation and compliance tools.

API Test Reports
Update test reports in seconds from API integrations

Automatically sync and update test reports through seamless API connections, eliminating manual data entry and reducing errors.

FDA Cybersecurity
Automate FDA Cybersecurity (SOUP Analysis)

Streamline Software of Unknown Provenance analysis with AI-powered cybersecurity compliance for FDA regulations.

Risk CoPilot
AI-powered risk assessment and management

Intelligent risk identification, assessment, and mitigation strategies powered by advanced AI algorithms.

Gap Analysis
Review documents against SOPs automatically

Automatically compare documents against Standard Operating Procedures to identify gaps and ensure compliance.

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