The pharmacovigilance audit universe consists of 100% of audit targets which will be audited in a span of 2-5 years. This information forms a part of the strategic audit plan that includes the auditing target, risk assessment, frequency and the year when audit will be performed.

Audit targets

These may include distributors, business partners, affiliates and vendors / service providers which may be undergo a pharmacovigilance audit. Besides, critical pharmacovigilance processes, system and even cross-functional departments may be considered as an audit target.

Risk Assessment Vs Audit Universe

Audit universe and risk assessment go hand in hand. While audit universe provides an idea of the audit targets, risk assessments help in determining the frequency of audit.

It is possible that some targets are audited 2-3 times in this timeframe.

It is also possible that a target it not audited in this timeframe due to termination of business relationship or in case of merger or acquisition.

However, that does not mean over-prioritization is done using the risk assessment against the audit universe. Let us learn this with an example. Imagine a company having 100 audit targets and the company has a strategic plan for five (5) years. This would mean a minimum of 20 audits every year. Risk assessment should not be a tool for identifying audit targets from this list of 20.

Frequency of Audit

Low-risk targets may be audited once in three (3) years, medium-risk targets every two (2) years and high risk targets every year. If there are quite a few audit targets, there is no harm in considering an audit once in five (5) years for low-risk targets. The only risk is when there is business termination before five years where you may never get a chance to undertake the audit, unless if audit-based qualification was performed in advance.

For 100% outsourcing model, it may make sense to undertake audit of the service provider every year. A plan can be created, e.g., ICSR management in 2025, PSUR management in 2026, and so on. If there is an adverse inspection outcome in the interim, the frequency and agenda may be tweaked.