Always‑Ready PV Framework
A Modern Approach to Pharmacovigilance System Governance
1. What the Always‑Ready PV Framework Is
The Always‑Ready PV Framework is a structured approach to pharmacovigilance system governance designed to ensure year‑round inspection readiness through clarity, control, and confidence.
2. What Regulators Expect
Regulators increasingly assess whether organisations understand how their PV system operates in practice, can demonstrate clear ownership and escalation, maintain consistent oversight across vendors, and document decisions coherently.
3. Common Weaknesses We See
Across inspections, we routinely see fragmented governance, unclear delegated responsibilities, mismatch between documented and operational systems, scattered evidence, and PSMFs that do not reflect reality.
4. What the Framework Delivers
Clear system maps and RACIs, predictable governance cadence, aligned vendor oversight, coherent inspection narratives, and sustainable, defensible compliance
Our Services
We offer services based on your journey. Discover our services based on your needs and inspection status (whether announced/confirmed or not).
Inspection Readiness
A Complete Guide for EMA, MHRA & FDA Expectations
1. What Inspection Readiness Means in Practice
Inspection readiness means being able to explain, evidence, and defend how the PV system works — without disruption — when challenged by EMA, MHRA, or FDA inspectors.
2. What Inspectors Actually Assess
Inspectors focus on governance effectiveness, decision‑making and escalation, MAH oversight of vendors, PSMF accuracy, and consistency across interviews, documents, and systems.
3. Typical Inspection Failure Patterns
Common findings include inconsistent SME answers, undocumented decisions, vendors operating outside defined controls, reactive oversight, and PSMFs disconnected from day‑to‑day practice.
4. How SMPV Limited Supports Readiness
SMPV supports inspection readiness through inspection‑style stress testing, interview rehearsal, evidence retrieval testing, governance stabilisation, and narrative alignment.
Our Approach
Whether you are expecting an inspection or not, inspection readiness starts with you. From process and system designs to improvements, evaluate your level of compliance now.
Vendor Oversight & Governance
How to Build a High‑Control, Low‑Friction Oversight Model
1. Why Vendor Oversight Fails
Oversight failures rarely result from intent; they arise from weak governance, over‑reliance on vendor reporting, unclear escalation rules, and misalignment between contracts, SOPs, and practice.
2. What Regulators Expects from MAHs
Regulators expect MAHs to retain demonstrable control, actively monitor delegated activities, identify and act on risks, and evidence oversight decisions.
3. Common Oversight Weaknesses
Collected KPIs not acted upon, subcontractor arrangements not fully understood, governance meetings without follow‑up, and oversight records that do not support inspection narratives.
4. SMPV Limited’s Oversight Model
SMPV Limited supports MAHs through structured governance design, escalation clarity, KPI frameworks, vendor alignment reviews, and inspection‑focused evidence optimisation.
5. Outcomes
- Reduced inspection risk
- Predictable vendor performance
- Transparent accountability
- Stronger MAH control
- Clear, defensible evidence trails
Control review
End-to-end process review allows a holistic evaluation of your system for strong governance and compliance.
PSMF Guide
Clarity, Coherence & Operational Reality
1. Why PSMFs Become Inspection Risks
Many PSMFs fail because they describe intended processes rather than real ones, lag behind system changes, under‑describe governance, and omit how decisions are made.
2. What a Coherent PSMF Looks Like
A strong PSMF accurately reflects operational practice, clearly describes governance, aligns vendor roles with MAH oversight, and supports consistent inspection narratives.
3. Common PSMF Issues We See
Outdated vendor lists, unclear delegation rules, missing governance documentation, contradictory process descriptions, and weak linkage to evidence.
4. SMPV Limited’s PSMF Coherence Review
Our review focuses on system mapping, governance reconciliation, operational alignment, inspection‑style challenge, and practical recommendations for sustainable updates.
Be Ready
Start with a quick snap shot review of the document to assess areas of improvements and risks straight away.
Take your inspection readiness to the next level.
Complete the scorecard to assess your readiness and have an immediate feedback on areas to improve.
The Plug-In Strategy.
Compliance That Fits, Confidence That Lasts.