According to Good pharmacovigilance rules of EAEU, pharmacovigilance audit is a systematic, structured, independent, and documented the process of obtaining an objective evaluation of the facts that characterize the work of the pharmacovigilance system.
The main purpose of an audit is to confirm the compliance and effectiveness of pharmacovigilance system implementation and functioning, through the analysis and evaluation of objective facts, including the quality system of the pharmacovigilance system.
X7 Research offers its services in performing independent audits of all existing processes in a company. Our pharmacovigilance staff can review your current pharmacovigilance system, identify weaknesses and make recommendations for improvement.
PREPARATION FOR REGULATORY AUDITS
ANNUAL INTERNAL AUDITS
X7 Research has been conducting pharmacovigilance audits in Russia, EAEU, CIS since 2010, including remote audits. The key points of our experts’ work are compliance with all regulatory requirements and high-quality preparation for audits.