GS1 Certified serialization and track-and-trace solution for pharmaceutical DSCSA, EU FMD, and FSMA 204 compliance. Low-code platform integrates with existing WMS, ERP, and MES systems for cradle-to-grave product tracking within distribution centers.
Körber STEPLogic TRACE is a GS1 Certified serialization and traceability solution designed to help pharmaceutical companies meet stringent compliance requirements including DSCSA (Drug Supply Chain Security Act), EU FMD (Falsified Medicines Directive), and FSMA 204 (Food Safety Modernization Act).
The platform has been in operation for 10+ years and was one of the earliest software solutions to help pharmaceutical manufacturers meet DSCSA guidelines. STEPLogic TRACE was integral to the first fully serialized pharmaceutical warehouse in 2013, for Johnson & Johnson.
STEPLogic TRACE provides comprehensive serialization capabilities including parent-child aggregation management, cradle-to-grave tracking within distribution centers, and reporting to compliance repositories. The EPCIS-compliant platform provides tamper-proof, audit-ready record keeping. It has been audited and validated for FDA Part 11 compliance.
The solution works with existing WMS, ERP, and MES systems through API-based integration, ensuring easy implementation with minimal workflow disruption. Powered by a low-code platform, STEPLogic TRACE is easily customizable for full or selective serialization based on business requirements. Deployment options include both on-premises and cloud solutions, scaling with business growth.
STEPLogic TRACE is the standard for numerous Fortune 100 drug manufacturers and third-party logistics providers. Beyond pharmaceuticals, the platform also serves food and beverage, electronics, and medical device industries. The solution has won the Supply Chain Innovation Award for its contributions to pharmaceutical traceability.
DSCSA enforcement began 27 May 2025, following the FDA's informal stabilisation period.
Pharmaceutical Edition
STEPLogic TRACE was designed from the ground up for pharmaceutical serialization compliance. The platform was developed in response to Johnson & Johnson's need to meet DSCSA compliance regulations and has been the standard for pharmaceutical manufacturers for 10+ years.
Core Capabilities
FDA & GxP Compliance
International Standards
Data Integrity & Validation
Körber STEPLogic TRACE offers flexible deployment options including on-premises and cloud solutions, scaling with business growth. The platform is built on a low-code architecture enabling easy customization without extensive development effort.
Integration capabilities include API-based connectivity with existing WMS (Warehouse Management Systems), WCS (Warehouse Control Systems), ERP, and MES systems. This ensures easy implementation with minimal workflow disruption. The platform enables handling of serialized products with existing WMS without facing high implementation costs.
STEPLogic TRACE is EPCIS (Electronic Product Code Information Services) compliant, providing standardized data exchange for supply chain visibility. The GS1 certification ensures interoperability with global traceability standards and compliance repositories.
The platform supports both full serialization and selective serialization based on business requirements. Real-time visibility features enable proactive decision-making and inventory control across supply chain operations.
When combined with Körber's PAS-X MES and STEPLogic WMS systems, implementation time is reduced by up to 50% with lower total cost of acquisition through the integrated offering.
Körber STEPLogic TRACE pricing is not publicly disclosed. Pricing is based on deployment model (on-premises or cloud), number of sites, transaction volumes, and configuration requirements.
The platform offers both on-premises and cloud deployment options. Körber claims up to 50% reduction in implementation time when combined with PAS-X MES and STEPLogic WMS systems.
Free trial availability is unstated. The solution serves Fortune 100 pharmaceutical manufacturers.
Körber Supply Chain sells and implements STEPLogic TRACE. Körber states over 30 years of industry experience across the group, and the platform itself has been in operation 10+ years. The solution works with existing WMS, ERP, and MES systems through API-based integration, ensuring easy implementation with minimal workflow disruption.
The platform enables handling of serialized products with existing WMS without facing high implementation costs. Implementation includes system configuration for full or selective serialization, integration with existing enterprise systems, validation support for FDA Part 11 compliance, and user training.
When combined with Körber's PAS-X MES and STEPLogic WMS systems, implementation time is reduced by up to 50% with lower total cost of acquisition through the integrated offering.
Körber Supply Chain provides comprehensive implementation services including site assessment, requirements analysis, system configuration, integration with existing systems, validation documentation, and go-live support. The unit has implementation experience with Fortune 100 pharmaceutical manufacturers. ISO 9001, ISO 27001 and SOC 2 certification covering Körber Supply Chain and STEPLogic TRACE is unstated; the ISO/IEC 27001 certificate and SOC 2 Type 2 attestation Körber publishes for PAS-X as a Service cover Körber Pharma's SaaS operating model, a separate business unit and a separate product.
PharmaSpotter assessment from published vendor and third-party sources. No user reviews are on file for this product.
Strengths
GS1 Certified, with 10+ years of operation including the first serialized pharma warehouse (2013). Award-winning solution used by Fortune 100 pharmaceutical manufacturers. EPCIS-compliant tamper-proof audit trails. Integration with existing WMS/ERP/MES systems. Low-code customization reduces implementation costs. Both on-premises and cloud deployment options. Supports DSCSA, EU FMD, and FSMA 204 compliance from single platform.
Limitations & Open Questions
Pricing not transparent and requires sales engagement. Limited publicly available third-party reviews (no G2 or Gartner Peer Insights). Only one named customer reference publicly available. Part of larger Körber ecosystem which may create vendor lock-in considerations.
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