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DSCSA Distributors’ White Papers: Distribution Software & ERP

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The Drug Supply Chain Security Act (DSCSA) has transformed how pharmaceuticals move through the U.S. supply chain. This white paper explains how cloud-native ERP platforms help pharmacy, pharmaceutical, and medical distributors manage unit-level serialization, EPCIS-based traceability, product verification, and authorized trading partner controls without relying on fragile point solutions.

Electrical Wholesale ERP Buyer’s Guide

What You’ll Learn in This DSCSA & Cloud ERP White Paper

The white paper turns DSCSA regulations into a practical technology roadmap: serialization at scale, EPCIS data exchange, verification, trading partner management, and audit-ready operations.

1. DSCSA Requirements Driving Modernization

Understand how DSCSA requirements for unit-level serialization, EPCIS-based traceability, product verification, and authorized trading partners impact enterprise systems and workflows.

2. Serialization at Scale

See how cloud ERP manages multi-level serialization hierarchies (unit, case, pallet) and embeds serialization into receiving, putaway, picking, packing, and shipping workflows.

3. EPCIS 1.2 Data Exchange & Interoperability

Learn how cloud ERP acts as a single source of truth for EPCIS event capture, real-time event generation (Commission, Pack, Ship, Receive, Decommission), and compliant data exchange.

4. Product Verification & Investigations

Discover how real-time verification requests, automated quarantine, and structured investigations are embedded into daily operations to protect patients and brands.

5. Managing Authorized Trading Partners

Review how cloud ERP automates ATP verification, license monitoring, and enforcement so that transactions occur only with appropriately licensed entities.

6. Architecture, Security & ROI

See why cloud-native architecture, API-first integrations, immutable audit trails, Part 11 support, and data governance are critical for compliant, scalable DSCSA operations — and how they deliver ROI.

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    Illustrative Benefits of DSCSA-Enabled Cloud ERP

    The white paper outlines how DSCSA-compliant cloud ERP delivers measurable gains that extend beyond compliance into operational excellence and customer trust.

    Compliance & Audit Readiness

    • 60–80% reduction in audit preparation time with immutable, centralized audit trails.
    • Automated EPCIS event capture and document workflows to support inspections.
    • Lower risk of violations and penalties through consistent controls.

    Operational Efficiency

    • 50–70% reduction in picking and serialization-related errors.
    • Faster verification and investigation cycles, with recall execution in days instead of weeks.
    • Embedded FEFO picking, quarantine workflows, and cold-chain checks in daily operations.

    Financial & Strategic Impact

    • 40–60% reduction in compliance-related manual work and rekeying.
    • Reduced expired inventory write-offs and improved service levels.
    • Stronger trading partner confidence and competitive differentiation through proven traceability.

    Frequently Asked Questions

    Does this white paper apply to both pharmaceuticals and medical devices?

    Yes. While DSCSA focuses on prescription drugs, the white paper also addresses related traceability requirements for medical devices (UDI), recalls, and field safety corrective actions for distributors that handle both product types.

    Can this help if we already have a legacy ERP?

    The content is designed for organizations running legacy ERP, point solutions, or partial DSCSA tools. It explains how cloud ERP can layer in serialization, EPCIS, and verification capabilities while providing a migration roadmap away from fragmented systems.

    Can we share this with our regulatory and QA teams?

    Absolutely. The white paper provides common language and structure to align IT, operations, QA, and compliance teams around a unified DSCSA and cloud ERP strategy.

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