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.
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.