Pharmacovigilance Audits and Inspections
PV Audits and Inspections
PV Audits:
We have expertise in performing PV audits in all pharmacovigilance areas, your PV System, Local Affiliates, Partners or Service Providers.
Audit Strategy and Planning:
We support creating audit strategic and tactical Plans, and risk-based audit planning.
CSV – Computer System Validation Audits:
We have expertise in Computer System Validation audits for your Safety database system.
Mock-Inspections:
We can support Mock-inspections, i.e. setting up an inspection scenario to practice prior to a real inspection, as well as help you with all the required tasks before, during and after an inspection.
Inspection Readiness:
We can prepare and train you and your PV System to be inspection ready