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DSCSA Compliance

Drug track and trace reporting for FDA DSCSA compliance with real-time ERP integration and package aggregation.

Solution by Juleb
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Overview

Juleb Connect's DSCSA Compliance module is a SaaS-based Drug Track and Trace solution designed to help pharmaceutical companies meet FDA Drug Supply Chain Security Act (DSCSA) requirements. It targets pharmaceutical distributors, manufacturers, and retailers seeking to achieve full serialization compliance without extensive infrastructure changes or complex data migration.

The platform has processed over 330 million aggregated serials and generated more than 5 million GS1 notifications, and integrates with existing ERP systems including SAP, Oracle, and Microsoft Dynamics.

Package Aggregation

  • Supports aggregation of packages anywhere within a warehouse environment.
  • Uses mobile devices to aggregate individual packages in accordance with GS1 standards.
  • Handles multiple package types, including pallets, cases, bundles, and individual products.

ERP Integration and Stock Matching

  • Integrates with existing ERP systems in a short implementation timeframe.
  • Provides real-time stock matching between scanned quantities and ERP orders.
  • Eliminates the need for complex data migration during onboarding.

Reporting and Visibility

  • Offers a user-friendly reporting interface with clear shipment delivery status.
  • Provides visibility into the full list of products, including batch breakdowns and total serials available per batch.
  • Supports reporting directly to DSCSA with batch-level detail.
  • Generates innovative and specific compliance reports tailored to pharmaceutical operations.

Scanning Technology

  • Incorporates computer vision technology for advanced package scanning and accuracy.
  • Designed for mobility, supporting flexible scanning locations across operations.

Comparison with Traditional DSCSA Solutions

  • Integrates with existing systems and operations, whereas traditional Drug Track and Trace Systems (DTTS) are described as separate from main operations.
  • Positioned as lower cost and lower effort compared to alternatives.
  • Designed for quick user adaptation, reducing the need for extensive training.
  • Supports flexible, mobile-focused workflows rather than location-restricted deployments.

Juleb Connect's DSCSA Compliance tool integrates with GS1 standards and connects to ERP platforms such as SAP, Oracle, and Microsoft Dynamics. It is available as a cloud-based SaaS solution and is positioned for pharmaceutical companies operating in distribution, retail, and manufacturing sectors.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Validation & GxP Compliance
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotech
Development stage(s)
ManufacturingPost-Market & RWE
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
GxP