Pharmacovigilance Audits

At OC Vigilance, we offer specialized pharmacovigilance audit services to ensure that product vigilance activities and systems meet the highest quality standards and international regulations. Our audits are conducted by auditors with extensive proven experience in the sector. These audits help identify areas for improvement, ensure compliance, and mitigate potential risks, providing transparency and confidence in the daily management of pharmacovigilance systems.
In our company, we understand that quality management is fundamental and we have a team of highly qualified auditors to ensure the robustness of your pharmacovigilance system through periodic audits and inspection support.
Our services include
- Internal and Compliance Audits
We conduct thorough internal audits to assess the effectiveness of pharmacovigilance systems and ensure compliance with local and international regulations. We identify areas for improvement and provide practical, concise recommendations tailored to the company type and available resources. - Supplier and Partner Audits
We evaluate external suppliers and partners to ensure they meet pharmacovigilance requirements and that their practices align with our clients’ quality standards and the regulatory requirements of the relevant country. - Pre-Inspection Audits
We offer audits to prepare your company for inspections by regulatory authorities. This includes reviewing documentation and processes to anticipate any potential observations or improvements. - Global Regulatory Compliance Assessment
Our team evaluates pharmacovigilance processes according to the requirements of various international authorities, such as the EMA, FDA, and other regulatory bodies, ensuring that your company complies with legal frameworks in all regions where it operates. - Corrective and Preventive Action Plan (CAPA)
We assist in the development and implementation of corrective and preventive action plans (CAPA) based on audit findings, supporting our clients in continuous improvement and risk minimization.