Certified PV Audits, Mock Inspections, and ISO Activities

Ensure compliance and quality with expert pharmacovigilance audits

Maintaining quality in pharmacovigilance isn’t just a best practice—it’s an essential obligation for Marketing Authorization Holders (MAHs) and clinical trial sponsors. 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. With our support, you can confidently meet regulatory expectations and maintain patient safety.

What are certified PV audits and mock inspections?

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.

Discover why PV audits and mock inspections are essential

Certified PV Audits, Mock Inspections, and ISO Activities - Vigilance - QbD Group - 1

Why are PV audits and mock inspections essential?

Quality maintenance in pharmacovigilance is a critical responsibility for MAHs and clinical trial sponsors. Certified PV audits and mock inspections ensure:

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.

Discover how we can support you

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 partner with QbD Group?

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.

Get in touch

Ready to strengthen your pharmacovigilance quality systems?

QbD Group provides certified PV audits, mock inspections, and ISO activities to ensure compliance, improve processes, and enhance inspection readiness. Contact us today to learn how we can help.

Certified PV Audits, Mock Inspections, and ISO Activities

What are certified PV audits and mock inspections?

Why are PV audits and mock inspections essential?

How can we help?

Certified PV audits