Case Study

Intelligent Pharma Compliance Assistant

An AI-driven assistant simplifies DSCSA compliance by verifying product legitimacy, detecting fraud, automating data reconciliation and generating audit-ready reports enhancing safety, efficiency and regulatory readiness in the pharma supply chain.

Problem

Statement

The pharmaceutical supply chain struggles with counterfeit risks, inconsistent data sharing and complex DSCSA compliance requirements leading to resource strain and potential threats to patient safety.

Solution

Proposed

  • Provides a chat-based assistant that allows users to check compliance status (e.g., “Is this batch DSCSA-compliant?”) using real-time blockchain and transaction data.
  • Identifies fraudulent activity by analyzing serialization patterns and chain-of-custody transitions.
  • Reconciles and corrects data from various formats, such as EPCIS files, automatically.
  • Generates FDA-ready reports for suspect product investigations and proactively alerts teams about potential compliance issues.

Business

Values

01

Reduces manual effort by streamlining DSCSA compliance checks.

02

Protects supply chain integrity by detecting fraud early.

03

Improves efficiency through intelligent data automation and validation.

04

Empowers non-technical users to manage compliance confidently.