2025: Audit Readiness Project (gbl biopharma)
Prepared a global medical information team for audit by identifying gaps, updating processes, ways of working, and quality documentation.
Working with the global regional MI leads on this piece of work, this project focused on proactively enhancing the global medical information team's readiness for both external and internal audits. The core objective was to ensure compliance and optimize operational efficiency. This involved a comprehensive gap analysis, followed by the development and implementation of updated processes and streamlined ways of working. A key component of the project was the meticulous revision and improvement of associated quality documentation. Collaboration with global regional Medical Information (MI) leads was central to the project's success, ensuring alignment with diverse regional requirements and best practices. The project employed a detailed Pharmaceutical Information & Pharmacovigilance Association (PIPA) 77-point checklist to guide the assessment and improvement efforts, providing a structured framework for achieving audit preparedness.
The project addressed the critical need for the global medical information team to maintain high standards of operational excellence and regulatory adherence. By anticipating potential audit challenges, the initiative aimed to minimize risks and ensure the seamless continuation of essential services. The gap analysis phase involved a thorough evaluation of existing processes, documentation, and practices against industry benchmarks and regulatory guidelines. This identified areas for improvement and formed the basis for subsequent development activities.
The updated processes and ways of working were designed to enhance efficiency, consistency, and accountability across the global medical information network. This included standardizing key procedures, clarifying roles and responsibilities, and implementing robust quality control measures. The revision of quality documentation ensured that all materials were accurate, up-to-date, and compliant with relevant regulations. The PIPA 77-point checklist served as a valuable tool throughout the project lifecycle, providing a structured approach to assess progress and ensure that all critical areas were addressed.