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SAP S/4HANA

Drug serialization and track-and-trace for pharmaceutical supply chains, enabling compliance with international serialization directives and counterfeit prevention.

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Overview

SAP Advanced Track and Trace for Pharmaceuticals is an application built on SAP S/4HANA that helps pharmaceutical companies meet international and regional drug serialization directives. It provides a corporate serialization repository, serial number management, and regulatory reporting capabilities, enabling organizations to fight counterfeit medications and maintain compliance with country-specific requirements while handling large volumes of serialization data.

The tool is designed for pharmaceutical supply chain operations where compliance with fast-changing serialization regulations is critical. It consolidates core serialization processes within existing ERP and warehouse environments, reducing the need for additional third-party vendors and lowering overall compliance costs.

Core Capabilities

  • Corporate serialization repository for tracking and managing trade-item serial numbers across markets
  • Serial number management, including tracking of serial numbers and their aggregations, sequential number ranges, and randomized serial number lists
  • Country-specific regulatory reporting to comply with regional serialization legislation
  • Readily available country compliance packages to address market-specific requirements
  • Integration of serialization processes into existing ERP and warehouse business processes

Data Integration and Event Management

  • Integration of master and transactional data within ERP and warehouse operations
  • Capture of serialized trade item events directly from packaging lines
  • Object and event repository capable of storing large volumes of objects, events, and business transactions
  • On-demand reporting based on captured repository data
  • Visibility into material movements down to the sales-unit-item level

Compliance and Regulatory Reporting

  • Supports compliance with international and regional directives aimed at combating falsified medicines
  • Tracks and traces serial numbers of retail products within a corporate repository
  • Provides regulatory reporting interfaces and country-specific content packages
  • Designed to scale and adapt as new legislation is introduced across markets

Deployment and Pricing

  • Available as SAP S/4HANA Cloud, private edition
  • Billed by objects, where an object represents any physical item managed via the cloud service
  • Sold in blocks of 12,000,000 objects, with a minimum quantity of seven blocks
  • Pricing structure and contract duration details are available on request

The application is suited for pharmaceutical organizations that require a scalable, integrated solution for serialization compliance, offering consolidated processes and built-in country content to reduce both implementation complexity and ongoing compliance costs.

Meta

Software type(s)
Workflow Automation
Deployment type(s)
Hybrid
Industry vertical(s)
Pharma
Development stage(s)
ManufacturingPost-Market & RWE
Target user(s)
QA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
GxP