Drug Traceability Process Standardization

Designed and implemented a comprehensive solution to standardize drug traceability workflows, creating an intuitive application for managing transmission history to the Italian Ministry of Health, tracking rejected submissions, and streamlining recovery operations.

Context

A pharmaceutical organization required a standardized and efficient system to manage drug traceability data and transmissions to the Italian Ministry of Health, facing challenges with manual tracking, error handling, and compliance.

Project Objectives

• Standardize the drug traceability process to ensure full compliance with Italian Ministry of Health regulations.
• Develop a user-friendly application with a graphical interface for managing the history of data transmissions.
• Implement robust functionalities to track and efficiently handle rejected submissions.
• Streamline recovery operations for rejected data to minimize manual intervention and errors.

Implemented Solution

I designed and implemented a full-stack application to centralize and automate drug traceability workflows. The solution included an intuitive front-end for user interaction, a robust backend for data processing and API communication, and a database for secure data storage. The application was containerized using Docker for simplified deployment and scalability.

Key Steps

• Requirement Gathering & Analysis: Collaborated with stakeholders to understand existing traceability workflows, compliance requirements, and pain points related to manual tracking and rejected submissions.
• System Architecture Design: Designed the overall architecture, defining the interaction between the React frontend, Node.js/Express.js backend, PostgreSQL database, and external XML-based APIs for Ministry of Health transmissions.
• Database Design & Implementation: Developed a PostgreSQL database schema to store transmission history, rejected records, and associated metadata, ensuring data integrity and efficient retrieval.
• Backend Development (Node.js/Express.js): Built a RESTful API to manage data, process incoming and outgoing traceability information, handle XML data parsing for Ministry submissions, and integrate with external systems.
• Frontend Development (React): Developed an intuitive and responsive graphical user interface (GUI) allowing users to easily view transmission history, filter rejected records, and initiate recovery operations.
• Error Handling & Recovery Logic: Implemented sophisticated logic within the application to automatically track rejected submissions, provide clear reasons for rejection, and guide users through streamlined recovery processes.
• XML Data Processing: Developed modules for generating and parsing XML files compliant with the Italian Ministry of Health's specifications for data exchange.
• Docker Containerization: Containerized the entire application stack (frontend, backend, database) using Docker, ensuring consistent development and production environments and simplifying deployment.
• Testing & Validation: Conducted thorough testing, including unit, integration, and user acceptance testing, to ensure the application's functionality, accuracy, and compliance.

Skills Used

Full-stack Development (Node.js, Express.js, React), PostgreSQL, XML Processing, API Development, UI/UX Design, Docker, Data Tracking and Reporting, Compliance Workflows, Requirement Gathering, End-to-End Solution Design, Problem Solving.

Outcomes

• Enhanced Compliance & Standardization: Successfully standardized the drug traceability process, ensuring adherence to Italian Ministry regulations and reducing compliance risks.
• Significant Reduction in Resolution Time: Improved the efficiency of handling rejected records, reducing resolution time by 80% through automated tracking and streamlined recovery operations.
• Decreased Manual Tracking Errors: Delivered an application that reduced manual tracking errors by 50%, leading to more accurate data and fewer discrepancies.
• Improved Operational Efficiency: Provided a user-friendly interface that empowered users to manage transmissions and rejections independently, significantly improving overall operational efficiency.
• Scalable & Maintainable Solution: The Dockerized architecture provided a robust, scalable, and easily maintainable solution for future enhancements and evolving regulatory requirements.