PV Audit-as-a-Service
Preparing for audits and inspections is an essential part of quality and compliance systems. Qinecsa provides comprehensive audit services to strengthen pharmacovigilance systems and ensure seamless compliance with regulatory standards and facilitate successful inspections.
Achieve Inspection-Ready Pharmacovigilance Systems
At Qinecsa, we provide specialised pharmacovigilance quality and audit services that evaluate all aspects of your pharmacovigilance systems against regulatory requirements and industry best practices. Regular, independent auditing of pharmacovigilance systems is essential for ensuring regulatory compliance and making operational improvements. Our expert team can help you with thorough, objective assessments, including:
- Overall pharmacovigilance system governance
- Case processing, safety and reporting workflows
- Audit scheduling design and implementation
- Ongoing compliance support with GxPs and local requirements
- Reviewing current systems and processes
- Gap analysis and remediation plan
- Designing and delivering an Inspection Readiness Plan (IRP)
We also develop customised services aligned with your specific organisational structure, objectives, or goals. Whether you need comprehensive system audits, targeted process reviews, or assessments, we design what’s most appropriate that address your particular circumstance or compliance obligations.
Expert team to ensure a compliant and audit-ready pharmacovigilance system.
System Audits
Complete range of services including audit schedule design, implementation, and ongoing support to ensure compliance with GxPs and local regulatory requirements.
Gap Analysis
Review of current system and processes against global and local regulations to identify suboptimal or missing strategies, processes, capabilities required to achieve the desired state of compliance.
Inspection Preparedness
Design and delivery of the Inspection Readiness Plan including review of systems, SOPs, and training of key SMEs.
Constructive Findings and Recommendations
At Qinecsa, our PV audit approach uses constructive improvement — we can help provide clear, actionable recommendations with practical implementation guidance that enhances system effectiveness while strengthening compliance.
Additionally, we can facilitate mock inspections that replicate regulatory authority approaches to prepare your organisation for official inspections. These assessments work to identify potential inspection vulnerabilities and help implement effective remediation measures.
Working with Qinecsa for Your Needs
Our team of quality and audit specialists bring extensive industry experience and regulatory knowledge to strengthen your systems and ensure you receive a thorough evaluation when meeting existing and emerging requirements. With a practical yet flexible focus, we aim to prepare and manage your audit or inspection needs to ensure a successful compliant process that meets global and local regulatory standards.
