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Vesdo specializes in the design and implementation of comprehensive serialization and track & trace systems. With extensive experience leading projects for pharmaceutical companies in Switzerland, Spain, and Germany, Vesdo ensures the creation of tailored serialization landscapes that meet the highest industry standards. Serialization is a critical component of modern pharmaceutical operations, driven by the need to enhance product security, comply with global regulations, and improve supply chain transparency. Implementing a robust serialization system is a demanding task, requiring careful planning, precise execution, and ongoing support. Vesdo brings expertise and experience to every phase of this process, ensuring that your company can meet the stringent demands of serialization without disrupting your core business operations.
The foundation of any successful serialization system lies in its design. Vesdo’s team of experts works closely with your organization to develop an optimal system architecture that aligns with your specific needs and operational goals. This involves analyzing your existing processes, identifying key requirements, and designing a system that integrates seamlessly with your current infrastructure. Whether you are looking to implement a full-scale serialization solution or upgrade your existing system, Vesdo ensures that the design is both scalable and future-proof, ready to adapt to evolving industry standards and technological advancements.
Selecting the right vendors is a crucial step in the serialization journey. Vesdo assists in this process through detailed Request for Information (RFI) and Request for Proposal (RFP) processes. We guide you in identifying potential vendors, evaluating their capabilities, and ensuring that their solutions meet your technical and operational requirements. Our vendor evaluation process is thorough and transparent, enabling you to make informed decisions that align with your long-term objectives.
A well-defined User Requirements Specification (URS) is essential to the success of any serialization project. Vesdo works with your team to develop a comprehensive URS that clearly outlines the functional, technical, and operational requirements of your serialization system. This document serves as a blueprint for system development, guiding both your internal teams and external vendors in the implementation process.
Compliance with regulatory standards is paramount in the pharmaceutical industry. Vesdo provides extensive support in the qualification and validation of your serialization system, ensuring that it meets all relevant regulatory requirements. From Installation Qualification (IQ) and Operational Qualification (OQ) to Performance Qualification (PQ), Vesdo ensures that your system is thoroughly tested and validated before it goes live, minimizing risks and ensuring smooth operation.
Before your serialization system is fully operational, it must undergo rigorous testing to verify that it functions as expected. Vesdo oversees User Acceptance Testing (UAT) and End-to-End Testing (E2E) processes, ensuring that all system components work together seamlessly. This testing phase is critical to identifying and resolving potential issues before they impact your production processes.
Serialization often involves collaboration with various business partners, including suppliers, distributors, and regulatory authorities. Vesdo facilitates the onboarding of these partners, ensuring that all parties are aligned and that data exchange processes are smooth and compliant. We manage the integration of your serialization system with external systems, minimizing disruption and ensuring a cohesive operation.
The pharmaceutical industry is subject to stringent regulatory requirements, and serialization systems must comply with a range of international standards, including the EU Falsified Medicines Directive (FMD), the U.S. Drug Supply Chain Security Act (DSCSA), and other global regulations. Vesdo ensures that your serialization system is fully compliant with all applicable regulations, helping you avoid costly fines and ensuring uninterrupted market access.
Even after your serialization system is up and running, ongoing support is essential to maintain its efficiency and effectiveness. Vesdo provides continuous operational support, addressing any issues that arise and ensuring that your system remains up-to-date with the latest regulatory changes and technological advancements. Our support services are designed to minimize downtime and keep your operations running smoothly.
With a deep understanding of the pharmaceutical industry and extensive experience in serialization, Vesdo is your trusted partner in navigating the complexities of serialization implementation. Our comprehensive approach covers every aspect of the process, from system design and vendor selection to testing, validation, and ongoing support. By partnering with Vesdo, you gain access to a team of experts who are dedicated to ensuring the success of your serialization project, allowing you to focus on your core business while we handle the intricacies of serialization.