GVP Audit Readiness in Pharmacovigilance
Prepared for Inspection. Built for Compliance.
Pharmacovigilance inspections assess organizational readiness, governance, processes, and documentation to ensure compliance and patient safety. Regulatory authorities evaluate the effectiveness of PV systems against global requirements.
SCIOM supports organizations in achieving GVP audit readiness in pharmacovigilance through comprehensive audits, gap assessments, and tailored remediation plans, ensuring systems are inspection-ready and aligned with regulatory expectations.
Audit Readiness Performance
Prepared. Compliant. Confident.
EMA GVP Aligned
Full alignment with European pharmacovigilance regulations
Risk-Based Audit Approach
Prioritized audits based on impact and risk
Inspection Readiness Support
Mock inspections and readiness exercises
Global PV Compliance Expertise
Coverage across EU, UK, US, and emerging markets
What We Assess in Our PV Systems
Assessing What Matters for Compliance
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PV governance and oversight structures
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Pharmacovigilance System Master File (PSMF)
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Case processing and safety reporting workflows
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Aggregate safety reports and submissions
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Signal detection and risk management processes
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Vendor oversight and PV agreements
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Documentation and record management
GVP Audit & Inspection Services
Be Ready. Stay Compliant. Pass with Confidence.
Pharmacovigilance audits and inspections require a structured and consistent approach to evaluate system effectiveness and regulatory compliance. The following areas are typically covered to ensure readiness and identify potential gaps:
- Risk-based pharmacovigilance auditsfocused on critical areas with the highest compliance impact
- Internal PV system audits to review governance, processes, and operational practices
- Affiliate and vendor auditsto assess compliance across external partners and third-party activities
- Mock regulatory inspectionsto simulate inspection scenarios and evaluate preparedness
- Inspection readiness assessments to identify gaps and areas requiring remediation
- Documentation and compliance review to ensure completeness and alignment with regulatory expectations
Structured CAPA & Remediation Management
From Findings to Lasting Compliance
Effective CAPA management requires a structured approach to ensure that audit findings are appropriately addressed and compliance is maintained over time. This involves identifying gaps, implementing corrective actions, and maintaining oversight to prevent recurrence.
Identification of audit findings and gaps through systematic review of pharmacovigilance systems and processes
Development of remediation plans aligned with regulatory expectations and organizational requirements
Implementation, tracking, and follow-up of CAPAsto ensure timely and effective closure of identified issues
Ongoing monitoring to support sustained compliance and continuous improvement
Structured Audit Approach
Structured Process. Reliable Results.
Aligned with Global Pharmacovigilance Standards
Built on Global Standards. Delivered with Precision.
Alignment with global pharmacovigilance regulations is critical to ensure consistent compliance and inspection readiness across markets. PV systems and processes are aligned with EMA GVP Modules, MHRA pharmacovigilance inspection requirements, and regulatory expectations defined by the FDA and Health Canada. In addition, adherence to ICH pharmacovigilance guidance supports a standardized approach to documentation, risk management, and overall system effectiveness, ensuring that regulatory expectations are consistently met.
Why Sciom for GVP Audit Readiness
Experience That Stands Up to Inspection
Pharmacovigilance audit readiness is supported by a combination of regulatory expertise, structured methodologies, and practical experience across global requirements. The approach is grounded in a clear understanding of inspection expectations and system-level compliance.
- Experienced PV auditors, QPPVs, and GVP specialistswith practical knowledge of pharmacovigilance systems
- Strong understanding of regulatory inspections across global health authorities and their expectations
- Risk-based and structured audit methodologiesto ensure focused and consistent evaluation
- Comprehensive CAPA planning and implementation to address identified gaps effectively
- Global pharmacovigilance regulatory insights to support alignment across multiple regions
Insights & Industry Trends
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