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🔧 Qualityze Adverse Event Management

Qualityze Adverse Event Management

Modernize Quality, Simplify Compliance.

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Overview

Qualityze Adverse Event Management is a cloud-based solution built on the Salesforce platform that helps life sciences organizations capture, manage, and report adverse events. It is designed to streamline workflows, ensure regulatory compliance, and improve patient safety. The system integrates with the FDA eMDR system for automated submissions.

✨ Key Features

  • Built on Salesforce platform
  • Integration with FDA eMDR system
  • Automated submissions in HL7 ICSR XML format
  • Signal detection and analysis
  • Configurable workflows and templates

🎯 Key Differentiators

  • Native Salesforce platform integration
  • Direct integration with the FDA eMDR system
  • Focus on both quality management and adverse event reporting

Unique Value: Provides a unified solution for quality and adverse event management on the Salesforce platform, with direct FDA eMDR integration.

🎯 Use Cases (3)

Adverse event reporting for medical device and pharmaceutical companies Organizations using Salesforce for their quality management system Automated electronic medical device reporting (eMDR)

✅ Best For

  • Seamless integration with the FDA eMDR system for streamlined reporting.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Companies not utilizing the Salesforce platform.

🏆 Alternatives

Cloudbyz Safety and Pharmacovigilance Other QMS software with adverse event reporting modules

Offers a more holistic approach by integrating adverse event reporting with other quality management processes.

💻 Platforms

Web

🔌 Integrations

Salesforce ecosystem FDA eMDR system

🛟 Support Options

  • ✓ Email Support
  • ✓ Phone Support
  • ✓ Dedicated Support (Enterprise tier)

🔒 Compliance & Security

✓ HIPAA ✓ BAA Available ✓ GDPR ✓ SSO ✓ FDA 21 CFR Part 820 ✓ ISO 13485

💰 Pricing

Contact for pricing

Free tier: NA

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