Instantly receive feedback where your documentation, oversight, and evidence may fall short under inspection.
A fast, readiness review for MAHs, QPPVs, and Heads of PV or QA
Most pharmacovigilance systems do not fail inspections because something is missing.
They struggle because confidence was assumed long before it was tested. This short checklist helps surface where inspection confidence currently depends on:
They struggle because confidence was assumed long before it was tested. This short checklist helps surface where inspection confidence currently depends on:
- individuals
- preparation
- reassurance rather than system behaviour.
Developed by PV compliance specialists with over 25 years of experience, our approach reflects the latest MHRA/EMA findings and best practices.
DISCLAIMER: The information provided will be shard with SMPV Limited. The content of this scorecard is informational and does not establish guidelines, standards or policies. Nothing in this scorecard should be construed as professional advice. SMPV Limited will not be accountable or liable for any losses or damages from the exposure or usage of this information.
Your Profile: Reviewed Across Three Critical Categories
Inspection readiness
This reflects your organisation’s ability to respond confidently and efficiently during regulatory inspections. Strong readiness minimises disruption, reduces risk of findings, and demonstrates a culture of compliance.
Vendor oversight
This evaluates the strength of your oversight of outsourced PV activities. Effective vendor management safeguards data integrity and compliance, reducing one of the most common sources of regulatory findings.
Leadership & Governance
This measures how effectively PV is managed as a strategic function. Robust governance ensures risks are visible, decisions are informed, and compliance is maintained proactively, not reactively.
Take the MAH PV Inspection Readiness Reality-Check Now
The value of this checklist is not the answers, it is knowing whether those answers are enough to support a confident decision.
What this helps you do
- Identify areas where inspection confidence may be assumed rather than tested
- Surface topics that often drive inspection scrutiny and escalation
- Decide whether current uncertainty is comfortable — or worth discussing further
- Create a shared view before committing to deeper work
Organisations use this as preparation for a short external sense‑check, to confirm whether acting now is justified, or whether waiting is reasonable.
