How do I ensure my serialized product tracking workflow with a track-and-trace platform is DSCSA compliant?

To make a serialized product tracking workflow DSCSA-compliant, you need to ensure your process supports product identification, traceability, verification, and interoperable data exchange across the supply chain.

Here’s a practical compliance checklist.

1) Serialize at the item level

Each saleable unit should have:

• GTIN or equivalent product identifier
• Serial number
• Lot number
• Expiration date

Typically this is encoded in a 2D Data Matrix on the package.

2) Maintain EPCIS-compatible event data

Your track-and-trace platform should capture and exchange transaction events in a standards-based format, usually:

• EPCIS 1.2 or 2.0 for event sharing
• Serialization data tied to physical movement
• Event types such as:
  • Commissioning
  • Shipping
  • Receiving
  • Aggregation / de-aggregation
  • Exception handling
  • Verification / status checks

3) Support full tracing at the package level

DSCSA requires you to be able to trace product one step up, one step down in the supply chain. Your workflow should preserve:

• Who you received product from
• What you received
• When and where it was received
• Who you shipped product to
• What was shipped
• When and where it was shipped

4) Exchange transaction data with trading partners

You must be able to provide and receive the required transaction information (TI), transaction history (TH), and transaction statement (TS), as applicable under DSCSA requirements and current implementation status.

Your platform should support:

• Partner onboarding
• Secure data exchange
• Validation of partner identity and licenses/authorizations
• Audit logs for all transfers

5) Verify suspect or illegitimate product

Your workflow should include an SOP for:

• Identifying suspect product
• Quarantining inventory
• Initiating verification requests
• Resolving discrepancies
• Reporting illegitimate product as required

6) Handle returns and recalls correctly

Make sure your platform can support:

• Saleable returns verification
• Quarantine of non-saleable returns
• Recall notification and execution
• Disposition tracking

7) Keep strong audit trails

Your system should record:

• User access
• Data changes
• Time stamps
• Product movement history
• Exception resolution

This is important for inspections and internal audits.

8) Validate your system and processes

Use documented validation to show that your system works as intended:

• Functional testing
• Security testing
• Data integrity checks
• Interface testing with trading partners
• Backup/recovery testing

9) Ensure cybersecurity and data governance

Because DSCSA involves sensitive supply chain data, your platform should include:

• Role-based access control
• Encryption in transit and at rest
• Authentication and logging
• Retention policies
• Data backup and disaster recovery

10) Align SOPs, training, and roles

Technology alone is not enough. You need documented:

• Standard operating procedures
• Training for warehouse, QA, and compliance teams
• Exception handling workflows
• Responsibility matrix for recalls, investigations, and data exchange

11) Confirm your platform supports FDA interoperability expectations

DSCSA is moving toward an interoperable, electronic tracing system. Your workflow should be able to:

• Exchange data electronically with trading partners
• Respond to verification requests promptly
• Support product tracing investigations within required timelines

12) Test with trading partners regularly

Before going live, run end-to-end tests for:

• Serialization commissioning
• Shipping/receiving data exchange
• Aggregation and pallet/case visibility
• Returns verification
• Recall response
• Suspect product resolution

A simple compliant workflow looks like this

1. Commission serialized units during packaging
2. Aggregate units into cases/pallets
3. Ship with EPCIS event data and transaction records
4. Receive and verify incoming product
5. Trace products by serial/lot if an issue arises
6. Quarantine and investigate suspect product
7. Report and remediate illegitimate product if confirmed

Common mistakes to avoid

• Missing or duplicate serial numbers
• Incomplete event capture
• Poor partner data exchange
• No aggregation hierarchy
• Weak audit trails
• Manual spreadsheets as the primary traceability record
• Lack of written procedures for exceptions

Best practice

Choose a track-and-trace platform that is:

• EPCIS-compliant
• Able to integrate with ERP/WMS/MES systems
• Built for secure partner data exchange
• Configurable for your specific packaging and distribution model
• Supported by validated SOPs and QA oversight

If you want, I can also give you:

1. a DSCSA compliance checklist,
2. a sample serialized workflow diagram, or
3. a gap assessment template for your current track-and-trace platform.