Creating effective vigilance systems
VigiDirect
On Vigidirect, you will find comprehensive guides on setting up a pharmacovigilance and vigilance system, designed to help you navigate regulatory requirements with ease. These guides include integrated training modules, ensuring that your team gains the necessary knowledge to establish, manage, and maintain a compliant pharmacovigilance system. Our goal is to empower you with the tools and understanding needed to sustain long-term compliance.
However, we also recognize that managing everything alone can be challenging. Beyond system implementation, it is crucial to ensure the availability of a qualified medical professional and maintain business continuity, particularly in cases of staff turnover or unexpected regulatory demands. To support you in these situations, we offer temporary and permanent pharmacovigilance service solutions.
Setting Up a Pharmacovigilance System
Establishing a robust pharmacovigilance system is a fundamental requirement for all Marketing Authorization Holders (MAHs) operating in the EU. The system has to be structured to ensure continuous monitoring of the benefit-risk balance of medicinal products and compliance with Good Pharmacovigilance Practices (GVP). This includes the implementation of a Pharmacovigilance System Master File (PSMF), adverse event reporting mechanisms, signal detection processes, and risk management strategies. A well-designed system integrates seamlessly with a company’s operations, ensuring that safety data is collected, assessed, and reported, while also being cost-effective and scalable to the company’s needs.
Setting Up a Vigilance System for Medical Devices
Establishing a comprehensive vigilance system is a fundamental requirement for all medical device manufacturers operating in the EU under Regulation (EU) 2017/745 (MDR). The system has to be structured to ensure continuous monitoring of device safety and performance throughout its lifecycle, in compliance with post-market surveillance (PMS) and vigilance requirements. This includes the implementation of incident reporting mechanisms, trend analysis processes, and field safety corrective actions (FSCAs) to mitigate risks. A well-designed system integrates seamlessly with a company’s quality management system (QMS), ensuring that safety data are collected, assessed, and reported in a timely manner to competent authorities, while also being cost-effective and scalable to the company’s needs.
Quality Management System (QMS)
To maintain regulatory compliance, the Quality Management System (QMS) for pharmacovigilance has to align with EU-GVP guidelines and be integrated within the overall company QMS. The QMS should include standard operating procedures (SOPs), work instructions, and clear documentation workflows to ensure that pharmacovigilance activities are conducted consistently and in accordance with regulatory expectations. Key elements include quality controls, audits, deviation management, and corrective and preventive actions (CAPAs). The QMS has to also support inspections and audits, ensuring that all pharmacovigilance processes are transparent, traceable, and ready for regulatory scrutiny at any time.
Ensuring Compliance and Continuous Improvement
An effective pharmacovigilance system is not static; it has to evolve with regulatory changes, company growth, and emerging gathering safety data. Continuous monitoring and periodic reviews of the QMS and (pharmaco)vigilance processes help identify areas for improvement and ensure ongoing compliance. Regular internal audits, training programs for personnel, and collaboration with external experts can enhance the efficiency and reliability of the system. By integrating digital solutions, automation, and data-driven approaches, companies can further optimize their pharmacovigilance activities, reducing administrative burdens while maintaining high safety and compliance standards.