X Pharma Plus helps organizations navigate pharmacovigilance audits and training with ease. We assess GxP systems, identify areas for improvement, provide remedial measures, and empower teams through customized training programs, including refresher, upskilling, and onboarding sessions.
Audits and Training Compliance Services in Pharmacovigilance – Overview
Adherence to policies, procedures, and regulatory requirements is critical throughout the medicinal product lifecycle. X Pharma Plus ensures the appropriateness and effectiveness of pharmacovigilance systems via risk-based audits and tailored training.
Audit Structure:
- Strategic-level audits: Long-term audit strategies endorsed by top management
- Tactical-level audits: Audit programs defining objectives, scope, and boundaries
- Operational-level audits: Individual audit plans prioritizing high-risk areas, risk-based sampling, and actionable recommendations
Our audits ensure compliance with global standards, including GCP, GVP, ICH Guidelines (E6, E2B(R3), E2C(R2)), US FDA safety-reporting requirements, and post-marketing safety reporting.
Audits and Training Compliance Services in Pharmacovigilance
“Comprehensive support for internal and external audits, CAPA implementation, KPI monitoring, and continuous training to maintain quality, compliance, and regulatory readiness.”