SAP ATTP – Overview, Features and Architecture
SAP Advanced Track and Trace for Pharmaceuticals (ATTP) is a specialized solution designed for pharmaceutical companies to effectively manage serial numbers, minimize compliance costs, and strengthen supply chain integrity. Its robust features ensure comprehensive visibility and traceability of pharmaceuticals, fully compliant with global serialization regulations.
SAP ATTP Overview
- Ensuring Visibility and Traceability: SAP ATTP's primary objective is to ensure seamless visibility and traceability of pharmaceuticals by meticulously adhering to stringent global regulations on serialization, tracking, tracing, and reporting. This commitment fosters transparency, accountability, and trustworthiness throughout the entire supply chain ecosystem, ultimately enhancing the integrity and reliability of pharmaceutical products.
- Overseeing Complex Supply Chains: ATTP plays a pivotal role in managing intricate supply chains, ensuring product genuineness, and mitigating risks associated with counterfeit activities or illicit diversions. This enhances brand reputation, bolsters consumer trust, and ensures stringent regulatory compliance.
- Centralizing data and analytics: By centralizing product data serialization, tracking, and incorporating comprehensive reporting and analytics capabilities, SAP ATTP empowers organizations to make informed, data-driven decisions, enabling continuous improvement and operational excellence in pharmaceutical supply chain management.
- Strengthening Pharmaceutical Supply Chains: Through fostering transparency, accountability, and operational excellence, SAP ATTP strengthens pharmaceutical supply chains, ensuring compliance with regulatory requirements, reducing counterfeiting risks, and building enduring consumer trust in the authenticity and safety of pharmaceutical products.
- Risk Mitigation: SAP ATTP employs advanced algorithms and data analytics to detect and mitigate risks associated with counterfeit products and unauthorized diversions within the supply chain. By implementing secure serialization processes and authentication mechanisms, it helps pharmaceutical companies protect their brands and maintain consumer trust in product authenticity.
- Equipped with robust features and functionalities, SAP ATTP serves as a vital tool for pharmaceutical companies to streamline serialization processes, mitigate compliance risks, and enhance supply chain security, ultimately contributing to the advancement of public health and safety.
SAP ATTP Features
- Serialization Management: Serialization management involves the systematic assignment and tracking of unique identifiers (e.g., serial numbers) to individual units of pharmaceutical products. It ensures compliance with global regulatory mandates by enabling precise identification and traceability throughout the supply chain.
- Aggregation and Disaggregation: Aggregation refers to grouping serialized units into larger entities (e.g., bundles, cases) for streamlined handling and distribution. Disaggregation involves breaking down these larger entities into individual serialized units. These processes optimize inventory management and logistics while maintaining traceability and compliance with serialization requirements.
- Regulatory Compliance: Regulatory compliance in pharmaceutical supply chains entails adhering to stringent serialization, tracking, and reporting regulations enforced by agencies such as FDA and EMA. SAP ATTP facilitates compliance by providing robust tools for data capture, audit trails, and regulatory reporting, ensuring adherence to mandated standards.
- Product Traceability: Product traceability involves tracking the complete lifecycle of pharmaceutical products, from manufacturing to distribution and beyond. SAP ATTP enhances traceability by capturing and managing serialized data at every stage, enabling rapid identification and resolution of quality issues and facilitating efficient recall management.
- Reporting: SAP ATTP offers advanced reporting capabilities for generating comprehensive insights into serialized product data, compliance status, and supply chain performance metrics. These reports support informed decision-making and regulatory submissions by providing actionable analytics on operational efficiencies and compliance metrics.
- Integration: Integration capabilities within SAP ATTP enable seamless connectivity with ERP, MES, and logistics systems, ensuring real-time data synchronization and visibility across the supply chain. This integration facilitates efficient management of serialized product data and enhances collaboration among stakeholders in compliance and operational workflows.
Architecture of SAP – ATTP
The architecture is designed to integrate seamlessly into pharmaceutical manufacturing and distribution environments, providing end-to-end visibility and control over product serialization, traceability, and compliance. Each layer plays a critical role in ensuring data integrity, regulatory compliance, operational efficiency, and secure data management throughout the product lifecycle.
- Database Layer: Responsible for managing structured data storage, including serialization data (unique identifiers for products), transactional information (events related to product movements), and detailed product specifications. It ensures robust scalability to handle large volumes of data and maintains data integrity through transactional consistency and relational database management.
- Application Layer: This layer hosts the core business logic and application services of SAP ATTP. It executes complex algorithms for transaction processing, manages serialization processes (assigning, capturing, and verifying unique identifiers), handles aggregation (combining serialized units into larger containers), and enforces compliance with regulatory standards (such as track-and-trace requirements).
- Integration Layer: Facilitates interoperability between SAP ATTP and other enterprise systems such as ERP (Enterprise Resource Planning), WMS (Warehouse Management Systems), and external stakeholders' systems (regulatory authorities, trading partners). It supports various communication protocols (like web services, messaging queues) to ensure seamless data exchange, synchronization of serialization data, and real-time visibility across the supply chain network.
- User Interface (UI) Layer: Provides multiple interfaces (web-based, desktop, and mobile) for users to interact with SAP ATTP. It offers functionalities for managing serialization activities (such as querying and updating product traceability data), monitoring compliance status, handling exceptions (like product recalls), and generating reports on serialization performance and regulatory adherence.
- Security Layer: Implements robust security measures to safeguard sensitive serialization data and ensure regulatory compliance. This includes access control mechanisms (defining user roles and permissions), encryption of sensitive data during transmission and storage, authentication (verifying user identities), and authorization (granting access based on roles and permissions).
- Analytics & Reporting Layer: Utilizes data analytics tools and reporting functionalities to generate actionable insights from serialization data. It provides predefined and customizable reports on supply chain performance, compliance metrics (like adherence to serialization regulations), and trends analysis. These insights help stakeholders make informed decisions, improve operational efficiencies, and ensure continuous compliance with regulatory requirements.
MAH View for SAP ATTP Architecture
The MAH (Marketing Authorization Holder) view in SAP ATTP serves as a specialized perspective within the system, focusing on enabling marketing authorization holders to manage serialization processes efficiently, ensure regulatory compliance, and gain actionable insights into supply chain operations.
MAH View encompasses several key functionalities and perspectives tailored to the needs of the marketing authorization holders in the pharmaceutical industry:
- Authorization and Access: Customizes permissions and access levels specific to the roles of marketing authorization holders, ensuring appropriate visibility and control over serialization and traceability activities within the system.
- Serialization Configuration: Empowers MAHs to configure serialization parameters such as serial number formats, aggregation rules, and other settings crucial for compliance with global regulatory standards. This capability enables MAHs to adapt to varying regulatory requirements across different markets efficiently.
- Compliance Management: Supports MAHs in maintaining compliance with global serialization regulations through robust tools for serialization, traceability, and compliance reporting. This includes functionalities for capturing and managing serialization data, verifying product authenticity, and responding to regulatory queries or audits effectively.
- Reporting and Analytics: Provides comprehensive reporting and analytics functionalities tailored to MAHs’ needs. This includes tracking serialization activities in real-time, generating compliance reports (such as serialization status reports and audit trails), and analysing supply chain performance to identify opportunities for optimization and regulatory adherence.
