How does Visiott’s track and trace solution ensure compliance with varying regulatory requirements across GCC countries, such as Saudi Arabia’s SFDA and UAE’s MoHAP guidelines?
At VISIOTT-TPS, we understand the complexity of pharmaceutical track and trace regulations across the GCC region, including Saudi Arabia’s SFDA (Saudi Food & Drug Authority) requirements and the UAE’s MoHAP (Ministry of Health and Prevention) guidelines.
Our serialization and traceability solutions are designed to ensure full regulatory compliance while maintaining operational efficiency and supply chain transparency.
Our solutions comply with GSl standards, aggregation, and serialization mandates required by the SFDA’s Drug Track & Trace System (RSD) and the UAE’s Tatmeen platform. We offer a configurable serialization infrastructure that aligns with evolving regulations across GCC countries.
What challenges do pharmaceutical companies typically face when integrating Visiott’s serialization and aggregation solutions with their existing manufacturing and ERP systems? How does Visiott address these challenges?
Pharmaceutical companies often face significant technical and operational challenges when integrating serialization and aggregation solutions into their existing manufacturing and ERP (Enterprise Resource Planning) systems.
At VISIOTT-TPS, we recognize these hurdles and have developed robust strategies to ensure seamless implementation with minimal disruption. Many pharmaceutical manufacturers operate with legacy ERP systems (SAP, Oracle, Microsoft Dynamics, etc.) that may not natively support modern serialization protocols. Also, there is Incompatibilities between Level 2 (line-level serialization), Level 3 (plant-wide serialization), and Level 4 (ERP) systems can cause data silos and inefficiencies.
Our solutions include APl-based connectors and middleware that enable seamless data exchange between serialization platforms and ERP/MES/WMS systems. We ensure full compliance with EPCIS 1.2 / 2.0 and other global serialization data exchange standards. Also, We provide customized ERP connectors for SAP ATTP, Oracle, and other major platforms to eliminate compatibility issues.
How does Visiott’s system manage and secure the vast amounts of data generated through serialization and track and-trace processes, ensuring real-time traceability and adherence to regulatory standards?
Serialization and track-and-trace processes generate massive volumes of sensitive data that need to be securely stored, efficiently managed, and instantly accessible for compliance, recall management, and supply chain visibility. At VISIOTT-TPS, we prioritize data security, real-time traceability, and regulatory adherence through our advanced serialization architecture and cybersecurity protocols.
Serialization generates vast datasets from manufacturing lines, packaging stations, warehouse systems, and distribution networks. Ensuring real-time tracking while preventing data bottlenecks and discrepancies across different levels of serialization (L 1-LS) is critical.
Our serialization system is optimized for real-time data capture and processing to handle high production speeds without delays. VISIOTT-TPS utilizes edge computing to process serialization and aggregation data locally, reducing dependency on cloud connectivity. Also, Our cloud and onpremises solutions ensure seamless allocation and tracking of serial numbers across multiple production sites.