FAQs answered for you.

A pilot is a limited production run:

• Test serialization on selected products
• Validate equipment and processes
• Train operators
• Identify issues before full rollout

SOP (Standard Operating Procedure) documents processes:

• Serialization workflow
• Exception handling
• System operations
• Compliance requirements

Required for GMP.

Change management handles system modifications:

• Document all changes
• Impact assessment
• Testing and validation
• Regulatory notification if required

CMO (Contract Manufacturing) transfer considerations:

• Serial number pool management
• System access and credentials
• Training for CMO staff
• Integration with CMO systems

ROI from serialization includes:

• Reduced counterfeiting losses
• Improved supply chain visibility
• Better recall management
• Enhanced brand protection
• Regulatory compliance (avoiding penalties)

Our EPCIS Analyzer tool helps you:

1. Upload your EPCIS XML or JSON file
2. View a summary of all events
3. Validate against country-specific requirements
4. Identify errors and get fix recommendations

Simply drag and drop your file or paste EPCIS content to get started.

Use our Barcode Decoder tool:

1. Enter the barcode data string (e.g., from a scanner)
2. The tool will parse and display all encoded data
3. View GTIN, serial number, batch, expiry, and other fields
4. Validate the check digit automatically

Visit our Regulation Hub for comprehensive information on:

• Country profiles and requirements
• Authority contacts and portal links
• Onboarding guides and timelines
• Technical specifications

Select a country to view detailed regulatory information.

TATMEEN integration steps:

1. Register your company on the portal
2. Obtain API credentials
3. Implement EPCIS message generation
4. Configure secure connection (HTTPS)
5. Test in sandbox environment
6. Go live after certification

Common reasons for EPCIS file rejection:

• Schema validation errors: Check XML/JSON syntax
• Invalid identifiers: Verify check digits
• Missing required fields: Ensure all mandatory elements are present
• Unregistered products/locations: Register master data first

Use our EPCIS Analyzer to identify specific issues.

RSD integration steps:

1. Register with SFDA
2. Obtain RSD portal access
3. Implement EPCIS capture interface
4. Configure API authentication
5. Complete testing phase
6. Receive production approval

A duplicate serial number error occurs when the same serial is used twice. Causes:

• System generating non-unique serials
• Re-using previously commissioned serials
• Data synchronization issues

Solution: Implement proper serial number management and validation.

The typical EPCIS events required for pharmaceutical track and trace are:

• ObjectEvent (Commissioning): Serial number assignment
• AggregationEvent: Packing/unpacking
• ObjectEvent (Shipping): Products leaving a location
• ObjectEvent (Receiving): Products arriving at a location
• ObjectEvent (Dispensing): Products given to patients

Specific requirements vary by country.

To print GS1 DataMatrix barcodes:

1. Use a printer capable of 300+ DPI resolution
2. Ensure proper quiet zones around the barcode
3. Follow GS1 size recommendations (minimum X-dimension)
4. Verify print quality with a barcode verifier

Consider using Continuous Ink Jet (CIJ), Thermal Inkjet (TIJ), or laser marking.

When EPCIS events fail:

1. Check error response from portal
2. Validate XML/JSON syntax
3. Verify all identifiers (GTIN, GLN, SSCC)
4. Ensure master data is registered
5. Check business rules compliance
6. Retry after fixing issues

A parent-child mismatch occurs when aggregation data is inconsistent:

• Child already in another parent
• Parent doesn't exist
• Unpacking before packing was reported

Solution: Ensure proper event sequencing and aggregation management.

Check digit errors occur when the last digit of a GTIN or SSCC doesn't match the calculated value:

1. Use the GS1 Modulo 10 algorithm
2. Recalculate the check digit
3. Compare with the actual last digit
4. Correct the barcode or data entry

Use our Barcode Decoder to validate check digits.

Common reasons for barcode read failures:

• Poor print quality (low contrast, defects)
• Wrong scanner type (laser vs imager)
• Scanning angle or distance issues
• Damaged or dirty barcode
• Inadequate lighting

Use a barcode verifier to check quality.

Master data is foundational reference data required before sending events:

• Product master: GTIN, description, NDC
• Location master: GLN, address, type
• Trading partner: Company information

Master data must be registered before transactional events.

A product not found error means the GTIN is not registered in the portal master data. Solution:

1. Verify GTIN format and check digit
2. Register product master data first
3. Wait for approval before sending events