DSCSA and Serialization: Compliance Without Slowing Shipments

Serialization is supposed to protect the supply chain, not choke it. Yet gaps in

traceability, partner misalignment, and sluggish exception handling can halt

shipments and erode trust.

This playbook keeps you DSCSA-ready without sacrificing velocity. You will map

EPCIS data flows, rehearse verification workflows, manage exceptions, and monitor

metrics so patient supply stays uninterrupted.

Why serialization excellence matters

Regulatory compliance: DSCSA requires interoperable, real-time traceability

across trading partners. Noncompliance invites enforcement and shipment holds.

Patient safety: Traceability prevents counterfeit or diverted products from

reaching patients.

Operational continuity: Smooth serialization keeps warehouses moving and

avoids costly quarantines.

Partner confidence: Distributors, wholesalers, and dispensers rely on your

data integrity.

Step 1: Map end-to-end EPCIS data flows

Document all EPCIS events (commission, pack, ship, receive, decommission) and

attributes exchanged with partners.

Validate master data alignment: GTINs, GLNs, SSCCs, batch numbers, lot

attributes.

Identify system owners (ERP, L3/L4 serialization, partner portals) and data

transformation points.

Test fallback procedures for partners incapable of consuming EPCIS messages in

real time (e.g., secure portals, email attachments).

Step 2: Strengthen verification workflows

Define who initiates verification, time limits, and escalation triggers.
Establish contact lists for distributors, 3PLs, and manufacturers with response

commitments.

Run drills simulating suspect product investigations; document response times

and data sources used.

Automate tracking of verification requests and closure, storing evidence for

DSCSA audits.

Step 3: Manage exceptions with a unified playbook

Create SOPs covering alerts, data mismatches, unreadable barcodes, and system

outages.

Automate alert routing to quality, regulatory, and logistics teams. Use ticketing

systems to ensure ownership.

Define quarantine rules, decision pathways, and communication templates for

trading partners.

Keep exception logs inspection-ready with timestamps, root cause, and corrective

actions.

Step 4: Partner integration and readiness

Conduct quarterly partner readiness reviews covering interface performance,

message success rate, and contact updates.

Share performance dashboards with partners to drive alignment.
Include serialization checks in supplier quality agreements and audits.
Provide onboarding guides for new partners covering data standards and testing

expectations.

Metrics that prove compliance without slowdowns

EPCIS transaction success rate and latency.
Average time to close verification requests and suspect product investigations.
Number of unresolved exceptions or quarantines older than SLA.
Master data error rate and time to correction.
Partner readiness scorecards (communication responsiveness, testing status).

45-day roadmap

Days 1-10: Map serialization partners, review data flows, and identify

master data mismatches.

Days 11-20: Test verification workflows with a key distributor, capture

response times, and refine SOPs.

Days 21-30: Update exception handling playbooks, automate alert routing,

and train stakeholders.

Days 31-45: Launch partner performance dashboards, schedule quarterly

drills, and track metrics.

Frequently asked questions

What should we test regularly? EPCIS message exchange, edge cases (returns,

recalls), and verification workflows with each trading partner.

How do we manage master data accuracy? Integrate governance with ERP and

product lifecycle systems; assign stewards to monitor key fields.

What if a partner is not DSCSA-ready? Provide integration support, document

gaps, and maintain contingency processes. Escalate persistent issues through

supply agreements.

How do we prepare for inspections? Maintain SOPs, training records,

exception logs, partner communications, and verification evidence in an audit-

ready repository.

Sustain the win

Schedule quarterly partner drills, refresh master data governance, and rotate

serialization SMEs so coverage stays strong. Share performance metrics with

leadership to maintain investment in serialization readiness. When compliance and

velocity coexist, your supply chain becomes a strategic asset.