Mastering Pharmaceutical Compliance with SAP ATTP
What is SAP Advanced Track and Trace for Pharmaceuticals?
SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP) is a solution for regulatory reporting to support compliance with global serialization regulations. It provides a corporate serialization repository and offers serial number management including regulatory reporting interfaces and content. SAP ATTP enables the ability to connect data from multiple pharmaceutical stakeholders to simplify compliance and avoid exclusion in key global markets.
SAP ATTP enables teams to:
- Integrate ERP systems, warehouse management systems and packaging lines
- Seamlessly incorporate serialization into standard business processes
- Report serialized object events to authorities and business partners
- Capture serialized objects from packaging lines and warehouse systems, storing related data in a central, accessible location
- Track and trace serialized medicinal sales units and their aggregated groupings
- Integrate serialized batches and link them to individual serialized items
- Globally manage number ranges and generate randomized or sequential serial number lists
- Access repository data to report on the global usage and distribution of serial numbers
Leverage SAP ATTP to Enhance Serialization & Compliance
Serialization and Regulatory Reporting to Fight Counterfeit Medicines
Counterfeit medicines can not only cause severe consumer health issues, but also have an economic impact on pharmaceutical companies. To improve patient safety, international governments are enacting legislation to fight counterfeit drugs. Many of these regulations require an item-level serialization of drugs and reporting to governmental or institutional databases and supply chain partners. Serialized trade item information is contained in a 2D barcode (GS1 Data Matrix) which is applied to medicinal sales unit packages. The 2D barcode contains the following information:
- Product identifier (GTIN)
- Expiry date
- Batch / Lot number
- Serial number (randomization provides the highest security)
Serialization in Practice
Compliance Business Challenges
The requirement for item-level serialization and regulatory reporting presents numerous challenges for the life sciences industry, including:
- Complying with country-specific regulatory and reporting requirements
- Integrating serialization into existing business processes
- Exchanging serialization data with relevant business partners
- Scaling to accommodate the high data volumes generated by serialization
Stakeholders such as market authorization holders, contract manufacturing organizations and wholesalers face these challenges at various levels. Each must meet different legal requirements to comply with serialization regulations, ensuring patient safety.
SAP ATTP was co-developed with leading pharmaceutical companies to simplify compliance and regulatory reporting. It efficiently integrates serialization with business processes and effectively manages serialization data.
How SAP ATTP Delivers Value
- Compliance: Easily comply with global serialization regulations by using only one corporate serialization repository.
- Integration: Reduce costs through efficient corporate serialization solution integration enabling seamless operations & business processes
- Scalability: Efficiently scale to high data volumes with SAP ATTP as a result of serialization.
Our Global Team of Specialists
Engineering’s Advantage
At Engineering Industries eXcellence, we specialize in delivering comprehensive Digital Supply Chain solutions that extend the benefits of Industry 4.0 beyond the factory floor. Our Digital Supply Chain methodologies help businesses maintain full visibility from raw material sourcing to product delivery, ensuring regulatory compliance, product authenticity and safety. Leveraging our expertise in Track & Trace, Product Serialization and SAP solutions, we enable end-to-end process and product traceability. This visibility allows businesses to optimize processes, increase customer service levels and safeguard brand integrity, all while adapting to the on-demand economy. As a trusted SAP partner, we also support enterprises across industrial sectors by providing customized digital transformation toolkits that ensure regulatory compliance, facilitate collaboration and deliver intelligent insights for continuous improvement.
