Pharmacovigilance Inspection Readiness

By performing a Mock Inspection, all individuals who are expected to take part in the inspection will understand their role. Followed with a detailed report summarizing open issues, it will allow you to benchmark your current PV system.

Check-lists for the readiness of the inspection day are crucial to success. iVigee can provide a detailed set of check-lists for different members of your PV team which will allow final preparations and readiness to be maximized prior to inspection.

For an optimal inspection process with the least amount of findings, training of all relevant employees is critical for best results. These trainings focus heavily on "How To" and "How Not To" answer inspectors questions which can avoid many setbacks.

Confidence in the behind-the-scenes actions of the inspected party can be the factor that leads to a successful inspection. Administrative tasks are numerous during an inspection and although often unnoticed, they are a determinant for the outcome.

Are you seeking on-site or remote real-time assistance during inspections? iVigee provides experienced pharmacovigilance professionals who can help with answering and determining the best course of action for responding to inspector queries.

Full support, and guidance and writing of inspection responses (with regulation references) is part of our suite of inspection services. CAPA writing and the combination of further actions (if applicable) are also available when appropriate.