GVP Audit Report Template | Good Pharmacovigilance Practice | Editable Word PDF | Drug Safety Internal Audit Checklist

GVP audits require structured documentation of pharmacovigilance system compliance, case processing, signal management, risk management, quality oversight, and CAPA—because inspection readiness depends on clear evidence and consistent reporting. This GVP Audit Report Format helps you streamline the audit process by capturing audit scope, findings, evidence, nonconformities, and corrective actions in one professional report—so your audit reporting stays consistent, complete, and regulator-ready.

This is a ready-to-use, professionally designed, and fully customizable audit report created to streamline your audit process. It supports internal audits, vendor audits, and pharmacovigilance compliance readiness by providing a standardized structure aligned with GVP expectations. Everything is organized to help auditors document checks faster, reduce reporting gaps, and improve closure of audit findings with clear ownership and timelines.

Whether you audit PV operations, service providers, QPPV oversight, safety databases, SOP compliance, or quality systems, this format supports stronger PV documentation and smoother management review and inspection preparation.

What’s Included:

• Audit cover page and report header (MAH/vendor, audit type, date, auditor details)
• Audit scope, objectives, criteria, and GVP reference section
• Pharmacovigilance system overview (org structure, QPPV, PV system master file fields—optional)
• Process-wise findings and evidence recording fields (ICSR, signal, RMP, PSUR—customizable)
• Case intake, processing, and reporting compliance verification section
• Signal detection, assessment, and escalation review fields
• Vendor oversight and quality agreement verification section (optional)
• Nonconformity/observation log with classification fields (customizable)
• Risk rating and severity assessment fields (customizable)
• CAPA section (root cause, corrective action, owner, target date, verification)
• Closing meeting summary, audit conclusion, management sign-off, follow-up timeline

Key Benefits:

• Streamlines GVP audit reporting with a standardized, ready-to-use format
• Improves inspection readiness with consistent evidence and classification
• Reduces reporting time with structured sections for findings and CAPA
• Supports faster corrective action closure with clear ownership and due dates
• Strengthens PV compliance visibility across processes and vendors
• Improves audit trail quality for regulators and management review
• Fully customizable for MAHs, CROs, PV vendors, and system scope
• Ideal for internal audits, vendor audits, and GVP readiness audits

Get your GVP Audit Report audit report format today and streamline your audit process.