EPCIS DSCSA Exceptions: How to Manage and Resolve Issues
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EPCIS DSCSA Exceptions: How to Manage and Resolve Issues

rfxcel, part of Antares Vision Group, delivers serialization, supply chain visibility, and compliance solutions for highly regulated industries. As DSCSA enforcement approaches in November 2025, one of the biggest challenges for Implementation Leads is managing EPCIS DSCSA exceptions.

Unresolved errors mean:

  • Products stuck in quarantine and millions in tied-up working capital
  • Audit failures and potential FDA penalties
  • Frustrated partners and delayed shipments
  • Costly manual reconciliation across teams

Antares Vision Group’s DIAMIND Sentry addresses this with Error Handling and Transaction Monitoring that resolve EPCIS errors in real time, prevent compliance gaps, and generate FDA-ready audit trails.

EPCIS DSCSA Exceptions at a Glance

EPCIS exceptions happen when serialized product data fails to validate or meet trading partner requirements. The most common categories are:

  • Missing or incomplete fields
  • Serial number mismatches
  • Late or incorrectly formatted EPCIS files
  • Unresponsive trading partners

Without automation, these issues escalate into operational delays, compliance exposure, and loss of partner trust.

How EPCIS DSCSA Exceptions Are Resolved with Error Handling and Transaction Monitoring

Antares Vision Group’s DIAMIND Sentry provides a comprehensive approach to error handling:

Capability DIAMIND Sentry Typical Competitor
EPCIS validation Schema + business rule checks Schema only
Transaction monitoring Real-time retries, escalations, alerts Manual or semi-manual
Audit trails FDA-ready, complete Partial, fragmented
Global compliance DSCSA + EU FMD + ANVISA + more Often DSCSA-only
Cold chain integration Built-in via rIM Separate, siloed
Support 24/7 global Limited coverage

This is the difference between resolving errors in hours instead of days and whether your organization can prove compliance without last-minute scrambles.

What ROI Should I Expect from Automated Error Handling?

ROI Driver Without Automation With DIAMIND Sentry
Quarantine time Days or weeks Hours
Labor cost Manual reconciliation across teams Significant reduction through automation
Audit prep Weeks of data gathering Minutes with pre-built reports
Working capital Millions tied up in returns Faster product release to market

Findings from Healthcare Distribution Alliance (HDA) pilots:

  • Up to 35% improvement in inventory accuracy
  • Up to 45% faster recall response times
  • Reduction in product unnecessarily quarantined

These results show the impact of combining EPCIS validation with automated error handling and transaction monitoring.

How Long Does Implementation Take?

Implementation speed is critical with enforcement deadlines approaching. Antares Vision Group typically delivers in:

  • Discovery & design: 2–4 weeks
  • Integration & data mapping: 4–8 weeks
  • Validation & partner onboarding: 6–10 weeks
  • Go-live & monitoring: 2–4 weeks

That means most organizations can be fully live in 12–16 weeks, fast enough to test, validate, and train before the FDA’s deadline. For the underlying serialization framework, see rfxcel’s serialization software.

Why Global Compliance Matters

EPCIS exceptions are not unique to DSCSA. EU FMD, Brazil ANVISA, and Russia MDLP all generate similar challenges. Managing these with different tools creates silos and increases risk.

Antares Vision Group’s global compliance solutions unify reporting and error handling across multiple markets, providing one consistent workflow.

Reducing Implementation and Integration Risks

Implementation Leads know the risks: partner onboarding delays, mismatched EPCIS versions, or failed validations. Antares Vision Group reduces these risks with:

  • Pre-built validation rules aligned with GS1 EPCIS standards
  • Backward compatibility across EPCIS schema versions
  • Sandbox testing environments
  • 24/7 global support to resolve issues immediately

This proactive approach avoids the costly delays companies face when error handling is treated as an afterthought.

Results You Can Expect

During HDA interoperability pilots, companies that combined EPCIS exchange with automated error handling reported faster partner responses, reduced quarantine volumes, and stronger audit trails. Antares Vision Group’s participation demonstrated that errors can be resolved in real time rather than weeks later.

For organizations with cold chain products, rfxcel Integrated Monitoring (rIM) adds condition data (temperature, humidity, shock) directly into DSCSA workflows, extending compliance from serialization to quality assurance.

Conclusion: Results and Next Steps

For DSCSA Implementation Leads, EPCIS error handling is not optional. Choosing a vendor that can resolve errors quickly and at scale determines whether your compliance program becomes a competitive advantage or a bottleneck.

With Antares Vision Group’s DIAMIND Sentry, you gain:

  • Error resolution in hours, not days
  • Reduced labor costs through automation
  • Proven compliance across DSCSA, EU FMD, and more
  • Faster recalls and fewer quarantined products
  • Full FDA-ready audit trails

Next steps:

Explore how error handling connects to end-to-end visibility with Antares Vision Group’s traceability software.

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