Pharmacovigilance Audits

Full Pharmacovigilance System Audits

iVigee auditors can audit all aspects of your pharmacovigilance system. After the pre-audit, audit, and post audit reports & review, all regulatory deficiencies will be documented and explained with steps to correct to ensure future success.

Gap Analysis

A precise analysis and follow-up report of what is needed when comparing a client’s existing PV System compared to an Optimal PV system for a specific aspect of pharmacovigilance. Geared towards an organization with an unresolved process issue.

Audit Strategy Assistance

Risk-based approach to display a practical and cost-effective audit plan. Periodic audit scheduling is essential to control resources and to ensure the compliance of existing partners with proper pharmacovigilance procedures.

Targeted Audits

Custom tailoring audits are part of our flexible approach at iVigee. Based on current situations, we can create a customized audit to target any known or expected deficiencies with your organization's PV system.

CAPA Development, Follow-up and Resolution

Creative and targeted proposals for corrective and preventative actions are part of our CAPA development services. At iVigee, we also focus on the follow-up and resolution of a CAPA to ensure our clients have progressed with any previous issues. Our team’s experience from the client, regulatory, and service provider perspectives ensures efficient CAPA development and resolution.

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