Pharmacovigilance (PV) Audits
Ensure compliance and quality with expert pharmacovigilance audits
At QbD Group, we provide certified PV audits, mock inspections, and ISO-related activities to ensure your pharmacovigilance system adheres to Good Pharmacovigilance Practices (GPvP) and international quality standards.
What are pharmacovigilance audits and mock inspections?
Maintaining quality in pharmacovigilance isn't just a best practice — it's an essential obligation for Marketing Authorization Holders (MAHs) and clinical trial sponsors.
Certified PV audits and mock inspections assess your pharmacovigilance system's compliance with GPvP requirements and ISO standards. These activities help identify gaps, improve processes, and prepare your organization for real regulatory inspections.
Key services include:
- Certified PV audits: Comprehensive evaluations of your pharmacovigilance system, processes, and documentation.
- Mock inspections: Simulated regulatory inspections to test readiness and address any potential compliance risks.
- Quality system assessments: Evaluating and optimizing your ISO-based pharmacovigilance quality management system.
- Compliance gap analysis: Identifying areas for improvement to align with GPvP and ISO standards.
- Corrective and Preventive Actions (CAPA): Guidance to implement effective CAPA plans based on audit findings.
Why are PV audits and mock inspections essential?
Regulatory compliance
Meet GPvP, EMA, FDA, and ISO requirements with confidence.
Inspection readiness
Be fully prepared for regulatory inspections with tested processes and documentation.
Improved quality systems
Identify gaps and implement solutions to enhance pharmacovigilance processes.
Risk mitigation
Proactively address compliance risks and prevent costly regulatory findings.
Operational efficiency
Streamline processes to improve productivity and maintain high-quality standards.
How can we help?
At QbD Group, we deliver tailored solutions to ensure the integrity of your pharmacovigilance system:
Certified PV audits
Conducting comprehensive audits to assess compliance with GPvP and ISO standards.
Mock inspections
Simulating real-world inspections to identify and address weaknesses.
ISO quality system optimization
Ensuring your pharmacovigilance processes meet international ISO standards.
Actionable CAPA support
Providing detailed plans to resolve findings and ensure continuous improvement.
Expert guidance
Leveraging years of experience to enhance your organization's inspection readiness.
Why QbD Group
Your trusted partner
When you partner with QbD Group, you gain:
Certified expertise
a team of qualified auditors with in-depth knowledge of GPvP and ISO standards.
Proven methodologies
comprehensive, systematic approaches to auditing and mock inspections.
Tailored solutions
customized support designed to address your unique challenges and processes.
Global experience
decades of expertise across international regulatory frameworks.
Continuous improvement
ongoing support to optimize quality systems and ensure compliance.
Let's talk Pharmacovigilance
From QPPV services to signal management, our safety experts are ready to support your pharmacovigilance needs.