DSCSA Compliance Solutions
DSCSA Compliance ensures pharmaceutical companies meet FDA requirements to securely trace and verify prescription drugs throughout the supply chain. Core Group Company, together with TrackTraceRX, delivers an integrated Odoo-based solution for serialization, transaction reporting, and verification that is scalable, cost-effective, and audit-ready. This approach protects patients, streamlines operations, and future-proofs compliance while reducing the burden of legacy systems
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DSCSA readiness checklist
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The Problem:
DSCSA Requires Pharmaceutical to Identify and Trace The Drug Supply Chain
The Drug Supply Chain Security Act (DCSCA) requires pharmaceutical manufacturers, repackagers, wholesalers, and dispensers to implement a secure, electronic, and interoperable system to identify and trace prescription drugs in the U.S. supply chain.
By 2025, the FDA mandates full unit-level traceability across all stakeholders.
Key Compliance Challenges
- Serialization Management – Unique identifiers (sNDC, lot, serial, expiration).
- Traceability & Transaction Reporting – TI, TH, TS exchange electronically.
- Verification Requirements – Return, recall, and suspect product checks.
- System Integration – Align ERP, WMS, and trading partners under one workflow.
- Audit & Enforcement Risk – Risk of fines, supply chain interruptions, reputational damage.
Our Solution:
Odoo and TrackTraceRX Connector
Core Group Company, in partnership with TrackTraceRX, provides a robust integrated solution that is cost-effective, scalable, and audit-ready for the serialization, transaction reporting, and verification of Drug Supply Chain Security Act compliant. Our solution ensures regulatory compliance, protects patients, and streamlines your operations—without the heavy cost of legacy systems.
Business Value
FDA mandates fully covered.
Patient safety ensured.
Streamlined compliance reporting.
Built to adapt with TrackTraceRX updates.
Lower total ownership cost vs. legacy compliance solutions.
How It Works
Full DSCSA Compliance in Five Steps
In just a few clicks, your team can configure even the most complex products and instantly generate error-free quotes.
Configure Odoo products with lot/serial control, GS1 identifiers, expiration tracking.
Extend Odoo’s Inventory & Sales modules for automated TI/TH/TS generation.
Seamless connector between Odoo and TrackTraceRX, our DSCSA compliance partner, for:
o Real-time partner data exchange
o FDA-compliant serialization reporting
o Secure TI/TH/TS interoperability
Seamless
Quality checks in Odoo for suspect, returned, or recalled product.
Compliance KPIs and automated record retention.
DSCSA Newsletter
Be the first to know what actually affects your audits.
We break down DSCSA requirements into clear, practical steps—backed by real project insights on serialization, EPCIS, and interoperability. Expect vendor-neutral guidance with quick takeaways you can act on immediately.
Contact Us
Ready to Simplify Your Tech Stack?
Let’s talk about how we can unify your software, automate your processes, and eliminate double data entry for good.
📞 Schedule your free consultation today.
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