PV Audit as a service offers comprehensive auditing solutions to ensure regulatory compliance and operational excellence in pharmacovigilance processes. At Atvigilx, we conduct thorough audits tailored to your specific needs and regulatory requirements. Our experienced auditors evaluate all aspects of your pharmacovigilance system, including SOPs, documentation, training, and signal detection processes.
Comprehensive Audit Preparation
Prepare thoroughly for audits by reviewing pharmacovigilance processes, assessing documentation, conducting mock audits, and facilitating training sessions.
Full range of services: audit schedule design, implementation, and ongoing support for compliance with GxPs and local regulatory requirements.
Gap Analysis
Assessment of current systems and processes against global and local regulations to identify deficiencies and gaps in compliance strategies and capabilities.
Inspection Preparedness
Development & implementation of an Inspection Readiness Plan, encompassing system reviews, SOP evaluations, and training for key Subject Matter Experts (SMEs).
