PharmaTrace is built as a pharmaceutical traceability platform capturing every batch and shipment event with immutable audit logging
Achieving 100% Batch Traceability from Raw Material to Delivery
Key results from this project
Batch Traceability Raw Material to Delivery
Reduction in Audit Preparation Time
Project Summary
PharmaTrace approached Hatzs to replace manual batch tracking and documentation with a platform that captured every batch and shipment event as it happened. The goal was 100% traceability from raw material to delivery and audit-ready records that didn't require weeks of reconstruction before an inspection.
Given DSCSA traceability requirements and GxP data integrity standards, PharmaTrace needed immutable logging built in from the start. Hatzs validated traceability and cold chain monitoring against real batch and shipment scenarios, including recall simulations, before go-live.
High performance components for demanding applications
They needed a technology partner to support its digital strategy
Given DSCSA traceability requirements and GxP data integrity standards, PharmaTrace needed immutable logging built in from the start. Hatzs validated traceability and cold chain monitoring against real batch and shipment scenarios, including recall simulations, before go-live.
- End-to-End Batch Tracking: Traceability from raw material receipt through manufacturing to final delivery.
- Immutable Audit Logging: Every batch and shipment event captured as it happens, not reconstructed later.
- Cold Chain Monitoring: Real-time temperature tracking for temperature-sensitive shipments.
Our Approach & Solution Delivery
PharmaTrace approached Hatzs to replace manual batch tracking and documentation with a platform that captured every batch and shipment event as it happened. The goal was 100% traceability from raw material to delivery and audit-ready records that didn't require weeks of reconstruction before an inspection.
Key implementation aspects included:
End-to-End Batch Traceability
Complete tracking from raw material through manufacturing to delivery, with every event logged immutably as it happens.
Cold Chain Monitoring
Real-time temperature tracking for sensitive shipments, with automated alerts when conditions fall out of spec.
Audit-Ready Reporting
Regulatory-ready export formats that cut audit preparation time by eliminating manual record reconstruction.
Results & Outcomes
PharmaTrace now maintains complete batch traceability from raw material to delivery, with audit-ready records available on demand.
- End-to-End Batch Tracking: Traceability from raw material receipt through manufacturing to final delivery.
- Immutable Audit Logging: Every batch and shipment event captured as it happens, not reconstructed later.
- Cold Chain Monitoring: Real-time temperature tracking for temperature-sensitive shipments.
- Recall Simulation Support: Workflows to trace and isolate affected batches during recall scenarios.
- Regulatory-Ready Reporting: Export formats aligned with FDA 21 CFR Part 11 and DSCSA requirements.
Given DSCSA traceability requirements and GxP data integrity standards, PharmaTrace needed immutable logging built in from the start. Hatzs validated traceability and cold chain monitoring against real batch and shipment scenarios, including recall simulations, before go-live.
Audits used to mean pulling people off production for weeks to reconstruct records. Now we pull a report in minutes and every batch is accounted for from start to finish.
