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🔧 Sparta Systems TrackWise Digital

Sparta Systems TrackWise Digital

The Leading Quality Management System.

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Overview

TrackWise Digital by Sparta Systems is a leading cloud-based quality management system (QMS) that helps life sciences companies manage quality and compliance. While not a dedicated pharmacovigilance system, it has strong capabilities for managing quality events that are closely related to pharmacovigilance, such as complaints, deviations, and CAPAs. It can be integrated with safety databases to provide a holistic view of product quality and safety.

✨ Key Features

  • Quality Management System (QMS)
  • Complaint Management
  • CAPA Management
  • Audit Management
  • Change Control
  • Integration with safety databases

🎯 Key Differentiators

  • Long-standing leader in the QMS market
  • Deep domain expertise in life sciences quality and compliance
  • Highly configurable platform

Unique Value: A comprehensive QMS that can be integrated with pharmacovigilance systems to provide a complete view of product quality and safety.

🎯 Use Cases (4)

Managing product complaints and quality events Integrating quality and safety data Ensuring compliance with GxP regulations CAPA management for safety-related issues

✅ Best For

  • Enterprise quality management for large pharmaceutical companies

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Organizations looking for a dedicated, end-to-end pharmacovigilance case management system

🏆 Alternatives

Veeva Vault Quality MasterControl ETQ

Offers more extensive quality management capabilities compared to the QMS modules of some PV systems.

💻 Platforms

Web API

🔌 Integrations

Oracle Argus Safety ArisGlobal LifeSphere Safety Veeva Vault SAP Salesforce

🛟 Support Options

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

🔒 Compliance & Security

✓ SOC 2 ✓ HIPAA ✓ BAA Available ✓ GDPR ✓ ISO 27001 ✓ SSO ✓ FDA 21 CFR Part 11 ✓ GxP

💰 Pricing

Contact for pricing

Free tier: NA

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