Preparing for Pharmacovigilance Audits: Best Practices for Compliance

Preparing for pharmacovigilance audits means knowing what auditors will sample (ICSRs, signal files, aggregate reports, PSMF sections, training records, vendor oversight, and CAPA) and fixing weak spots before the opening meeting. Last-minute binder assembly rarely survives document requests that follow the live process. Preparation is also about people: process owners who can explain how work actually happens, including known gaps and the plans attached to them.

Viltis supports audit preparation for sponsor, partner, and authority audits with readiness reviews, storyline coaching for process owners, and targeted remediation of high-visibility gaps. We run document walks that mimic real requests, confirm that the PSMF matches practice, and help teams rehearse explanations for known issues without scripting fiction. Preparation includes logistics: rooms, subject-matter expert lists, request tracking, and escalation paths during the audit week so responses stay controlled under time pressure.

Known issues should arrive with CAPA status, owners, and dates, not surprise the audit team mid-week. We help assemble an issues list that is honest and current, then coach SMEs on how to discuss it without oversharing or minimizing. Auditors respect controlled transparency more than polished denial when the records already show the gap. We confirm translator and document retrieval logistics for multi-country systems so request turnaround stays realistic. Request logs from prior audits guide what to rehearse first. Opening meeting talking points stay factual and short.

Audit preparation typically covers

• PSMF and key SOP consistency checks
• Sample ICSR and signal file dry runs
• Training and job description alignment
• Vendor oversight evidence packs
• Open CAPA status and overdue risk review
• SME briefing and Q&A practice
• War-room logistics and request tracking

Ready teams answer from controlled records, not memory. Viltis helps you enter the audit knowing your real strengths and residual risks, with owners assigned for anything that still needs a plan. After the audit, we can help translate observations into CAPA that fixes the process rather than producing cosmetic documents. If the audit date is close, we prioritize high-visibility samples, SME readiness, and open CAPA hygiene so the team is not inventing answers under pressure.