QPPV.COM KNOWLEDGE ASSESSMENT

Audit Programme Management in Pharmacovigilance: Knowledge Assessment

Test your understanding of the concepts covered by Audit Programme Management in Pharmacovigilance.

Question 1 of 10Pass mark: 80%

Question 1 of 10 A high-risk vendor has undergone a major system migration. What is the most appropriate programme response?

Wait for the next routine audit because the vendor was audited previously Remove the vendor from the universe because migration is a project rather than a PV process Update the universe, reassess risk and plan timely targeted assurance, potentially including an interim review Audit only the vendor’s financial controls

Question 2 of 10 Which situation represents a clear independence concern?

An auditor reviews evidence from a vendor managed by another department An auditor audits a process for which the auditor has current operational responsibility An auditor uses specialist technical expertise during a vendor audit An external auditor provides an independence declaration

Question 3 of 10 A company’s new outsourced safety database supports case processing and regulatory reporting. Why should it receive particularly strong audit attention?

Outsourced systems are automatically higher risk under every circumstance A failure could affect critical data integrity, case completeness or timeliness across downstream PV activities Vendor audits focus primarily on procurement savings Database vendors are outside the scope of the PV audit universe

Question 4 of 10 When should the audit universe normally be reviewed or updated?

Only after a regulatory inspection At least annually and whenever the PV system materially changes Only when a high-severity finding is issued Every five years, regardless of organisational changes

Question 5 of 10 Which combination of programme characteristics best indicates maturity?

A high number of audits with no trend analysis or evidence of risk reduction Strict adherence to a fixed schedule even when the PV system changes A clear link from risk assessment to audits, effective CAPAs, trend-based improvement and proactive prevention Reliance on external auditors without internal governance

Question 6 of 10 Which event is most appropriate as a trigger for a reactive audit?

A routine governance meeting with no new information A major vendor SLA breach or serious safety-related incident Completion of an audit with no findings A scheduled annual review of the audit universe

Question 7 of 10 What is the most appropriate interpretation of the impact dimension in PV audit risk scoring?

The number of documents expected to be sampled The potential consequence for patient safety, regulatory compliance or business continuity The number of auditors needed to perform the audit The financial cost of conducting the audit

Question 8 of 10 What is the most appropriate role of the QPPV in relation to audit programme outputs?

To conduct every audit personally To receive outputs, use them in system-wide risk assessment and ensure that necessary action is taken To replace the Head of Quality as owner of audit methodology To approve every sampling decision made by an auditor

Question 9 of 10 Why is effectiveness verification different from simply closing a CAPA task?

Effectiveness verification checks whether the root cause and resulting risk have been addressed, rather than only whether an action was completed Effectiveness verification is an administrative step that replaces root-cause analysis Closing a CAPA task automatically proves the system has improved Effectiveness verification is needed only for minor documentation findings

Question 10 of 10 Which assignment is most appropriate when maintaining an audit-universe entry?

The auditor should own the process and approve its remediation A named process or system owner should be accountable for evidence and remediation, while remaining separate from the auditor The QPPV should personally own every universe item The vendor should own the company’s internal audit-universe record

Audit Programme Management in Pharmacovigilance: Knowledge Assessment

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