But even life science companies that have been running serialization for years still encounter avoidable mistakes – errors that can cause product quarantines, failed verifications, and even regulatory fines. Here are the five most common issues I’ve seen in the field, and how to fix them before they become costly problems.
1. Poor EPCIS data quality
The problem: Serialization data appears to process in your system – but fails when it hits a trading partner’s EPCIS repository. Common errors include:
• Missing required fields
• Incorrect GTINs or SGTINs
• Mismatched packaging hierarchies
The fix:
• Run pre-validation before sending any EPCIS file externally.
• Use standardized templates aligned with GS1 guidelines.
• Build error-handling workflows to flag and correct issues automatically.
2. Weak exception handling
The problem: Damaged labels, unreadable barcodes, and returns that don’t match the original shipment happen all the time. Without a process to handle them, serialized units can get stuck in limbo.
The fix:
• Define SOPs for handling edge cases at receiving, packing, and returns.
• Train staff on when to rework, decommission, or destroy a serialized unit.
• Document all exceptions for compliance audits.
3. No Real-Time Verification
The problem: Relying on batch processing or end-of-day checks means you find problems too late – after the product has shipped.
The fix:
• Implement ATP (Authorized Trading Partner) checks in real time.
• Validate barcodes and data at each handoff point, not just at the end.
• Use a serialization platform that integrates verification directly into your workflows.
4. Siloed Systems
The problem: Your serialization system isn’t fully integrated with your WMS, ERP, or manufacturing execution system (MES). That leads to gaps in product history and manual workarounds.
The fix:
• Use APIs or middleware to connect systems so data flows automatically.
• Map data ownership so that you know which system is the source of truth for each field.
• Test integrations under real operational loads, not just in staging.
5. Lack of Ongoing Monitoring
The problem: Serialization gets treated as “done” after go-live. Without ongoing monitoring, small errors creep in over time, eventually causing big problems.
The fix:
• Schedule regular health checks on your serialization environment.
• Audit sample EPCIS transactions monthly.
• Keep your compliance configurations updated to match new regulatory guidance.
Bottom Line
Serialization mistakes cost more than just time – they can put products, patients, and your business at risk. The good news? Most are preventable with the right processes, tools, and oversight in place. STEPLogic Trace is built to help pharma companies catch issues before they become violations – integrating EPCIS management, real-time verification, and exception handling into one platform. Check out our DSCA Compliance Guide.
