Make your real PV system visible.
2–3 weeks
Deliverables:
- PV System Map (critical handoffs + vendors)
- RACI (lite)
- PSMF alignment snapshot
- Top‑10 micro‑failures
- Prioritised next‑10 actions
Outcome:
Immediate clarity on risk, roles, and operational gaps.
Build predictable control and defensible oversight. 6–8 weeks
Deliverables:
- E2E process deep dives
- Interaction dry‑runs
- Governance cadence (monthly/quarterly)
- Vendor oversight framework
- Inspection playbook + SME coaching
- PSMF update loop
Outcome:
A system that behaves consistently, under pressure and in daily operations.
Prove defensibility before inspectors ask. 3–6 weeks
Deliverables:
- Full E2E stress‑test
- Topic‑based interview rehearsal
- Risk scenario simulations
- PSMF coherence audit
- Opening inspection narrative
Outcome:
A coherent, confident system narrative supported by evidence.
WHAT MAKES US DIFFERENT?
Interaction lens
Interaction lens
Interaction lens
PV–QA–Reg–Medical–Vendors
Governance rhythm
Interaction lens
Interaction lens
Decisions/Minutes/KPIs with narrative
PSMF COHERENCE
Interaction lens
PSMF COHERENCE
Practice ↔ Paper
Why Choose SMPV Limited? The plug-in strategy
SMPV Limited Consulting: Your Partner in Inspection Readiness
We are not a CRO. We don’t offer operational PV, case processing, or QPPV. We partner with your PV vendor and focus MAH‑side governance, oversight and inspection defensibility
- We do not dilute focus with case processing or database hosting.
- We specialise in quality maturity, the foundation of sustainable compliance.
- We plug in without disruption, working alongside your PV operations team.
- Senior PVQA expertise only; no junior auditors
- System‑level clarity, not checklist‑level remediation
- Modular, scalable compliance support that integrates with your operations
- Regulator‑aligned thinking (EMA GVP, MHRA GPvP, FDA expectations)
- Designed for lean teams: predictable, lightweight, high‑impact
- Practical improvements that strengthen governance, oversight, and SME confidence
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.