Assure-Trak Compounding Management System
Compounding management system for DQSA compliance.
Overview
The Assure-Trak Compounding Management System is designed to address the unique operating requirements of 503B outsourcing facilities. It incorporates both pharmacy-based compounding and pharmaceutical manufacturing principles to help customers meet FDA-mandated compliance guidance under the DQSA.
✨ Key Features
- Order Management Module
- Integration with DEA's CSOS
- Manages both hub-and-spoke and distribution models
- Designed for DQSA compliance
🎯 Key Differentiators
- Treats compounding as a manufacturing process, focusing on minimizing process variation.
- Creates a 'living document' batch record that captures real-time data.
- Focus on hospital pharmacy workflows and compliance.
Unique Value: Standardizes the sterile compounding process to a manufacturing level of control, ensuring higher quality, safety, and compliance.
🎯 Use Cases (3)
✅ Best For
- Built specifically to address the increased regulation and compliance requirements of outsourcing facilities.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Not intended for 503A pharmacies or other non-503B entities.
🏆 Alternatives
Goes beyond simple task documentation by actively managing and enforcing the compounding workflow to prevent deviations, rather than just recording them.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Phone Support
- ✓ Dedicated Support (Varies tier)
🔒 Compliance & Security
💰 Pricing
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