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Frequently Asked - Find answers to common questions about Track & Trace
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Country-Specific 6
Data 10
A verification response confirms product authenticity:
- GTIN + Serial + Lot + Expiry verified
- Response: Valid/Invalid/Unknown
- Required at point of dispense
- Real-time query to repository
Lot number: Identifies production batch (many units share same lot)
Serial number: Unique identifier for each unit
- Both required for full traceability
- Lot = quality tracking
- Serial = individual tracking
Master data is reference information:
- Product data (GTIN, description)
- Location data (GLN, address)
- Trading partner data
- Must be synchronized across systems
Batch traceability tracks products by production batch:
- Same lot number = same production run
- Enables batch-level recalls
- Links to quality records
- Part of GMP requirements
Exception handling manages serialization issues:
- Rejected units on line
- Failed submissions to portal
- Verification failures
- Data discrepancies
Requires documented procedures.
Key difference:
- Master data: Static reference data (product info, locations)
- Event data: Dynamic transaction records (what, when, where, why)
Both needed for complete traceability.
Data synchronization keeps data consistent:
- Between internal systems
- With trading partners
- With regulatory portals
- Critical for EPCIS accuracy
Compliance reports demonstrate regulatory adherence:
- Serialization status by product
- Event submission statistics
- Error rates and resolution
- Required for audits
A transaction ID links business transactions:
- Purchase order number
- Invoice number
- Delivery note number
- Required in EPCIS transaction events
Data retention requirements:
- Keep records for specified period
- Typically 1 year after expiry + buffer
- Country-specific requirements
- Must be retrievable for audits
EPCIS 4
EPCIS stands for Electronic Product Code Information Services. It is a GS1 standard for sharing event data between trading partners in the supply chain.
EPCIS defines four event types:
- ObjectEvent: Observation of objects (commissioning, shipping, receiving)
- AggregationEvent: Parent-child relationships (packing/unpacking)
- TransactionEvent: Links objects to business transactions
- TransformationEvent: Input/output relationships (manufacturing)
An ObjectEvent captures observations about objects at a point in time. Common uses:
- Commissioning (serial number activation)
- Shipping (products leaving a location)
- Receiving (products arriving)
- Dispensing (products given to patient)
Action types: ADD, OBSERVE, DELETE
An AggregationEvent records parent-child relationships between containers and their contents:
- ADD: Items packed into a container
- DELETE: Items unpacked from a container
- OBSERVE: Confirmation of aggregation
Essential for case and pallet tracking.