Independent Pharmacovigilance Audits Independent assurance.

We audit PV systems, processes and third parties to help senior PV leaders understand:

• Where risk and exposure sit
• Whether controls work in practice
• Whether documented processes reflect what is actually happening
• Where leadership attention could make the greatest difference

An audit should do more than produce findings.

It should give you a clearer understanding of your PV system and confidence in what needs attention next.

You may be:

• Delivering your approved PV audit programme
• Assessing an internal PV system or process
• Selecting or overseeing a third-party provider
• Responding to concerns about performance or compliance
• Following significant organisational, system or vendor change
• Reviewing whether previous corrective actions have been effective
• Seeking independent assurance before regulatory scrutiny

Whatever the trigger, the audit should be designed around the risks, responsibilities and decisions that matter to your organisation.

SMPV Limited provides independent audits across the pharmacovigilance system.

PV system audits

Independent assessment of how the PV system operates across processes, functions, interfaces and third parties.

The audit considers whether responsibilities, controls and evidence support the organisation’s regulatory obligations in practice.

PV process audits

Focused assessment of a defined PV process or risk area.

The scope is agreed around the organisation’s responsibilities, known concerns and intended audit outcome.

PV vendor and service provider audits

Independent assessment of outsourced PV activities and the controls supporting them.

The audit looks beyond vendor performance in isolation to consider the organisation’s oversight, decision-making, escalation and continuing accountability.

Targeted and risk-based audits

Focused audits where a particular concern, change, signal or emerging risk requires independent examination.

This can help leadership determine whether the issue is isolated or points to a wider system weakness.

Audit follow-up and CAPA effectiveness reviews

Independent review of whether corrective and preventive actions have addressed the underlying issue and are working as intended.

Senior PV quality expertise throughout

Your audit is led and delivered using senior pharmacovigilance and quality expertise.

You are not commissioning a generic audit approach applied to a specialist PV system.

More than checklist compliance

Regulatory requirements provide the foundation.

But an effective audit also needs to examine how responsibilities, decisions, oversight and controls operate in practice.

System-level thinking

An individual observation may be a symptom of something wider.

A documentation issue may point to unclear ownership.

A vendor issue may reveal an oversight weakness.

A recurring corrective action may indicate that the underlying cause has not been addressed.

SMPV considers what individual observations may reveal about the wider PV system.

Findings that support decisions

The objective is not to create the longest possible findings list.

It is to provide clear, evidence-based conclusions that help leadership understand:

• What matters
• Why it matters
• What requires attention
• Where wider investigation may be justified