QPPV.COM KNOWLEDGE ASSESSMENT

Pharmacovigilance Audits: Knowledge Assessment

Test your understanding of the concepts covered by What Is a Pharmacovigilance Audit?.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which planning activity most directly supports independence before fieldwork begins?

Increasing the number of interview questions Completing conflict-of-interest checks and defining reporting lines Requesting only documents that support the expected conclusion Allowing the auditee to approve the final findings

Question 2 of 10 What is the appropriate interpretation of audit closure?

Closure automatically proves that the risk has been eliminated Closure means the report has been issued, regardless of CAPA status Closure should depend on meeting verification criteria and retaining objective evidence Closure is achieved when the auditee disagrees with the finding

Question 3 of 10 When auditing electronic safety-system data, which additional information is particularly important for evidentiary reliability?

The auditor's preferred software brand System user, timestamps, export parameters and filters used The number of pages in the final audit report The personal opinions of system users

Question 4 of 10 What is the most important distinction between a pharmacovigilance audit and a regulatory inspection?

Audits assess only vendors, whereas inspections assess only internal activities Audits are organisational assurance activities, whereas inspections are regulatory oversight activities Audits are always continuous, whereas inspections are always remote Audits have no compliance focus, whereas inspections have no improvement focus

Question 5 of 10 Which audit programme characteristic would most concern a regulator?

The programme uses risk assessments and inspection history to set priorities The QPPV receives audit outcomes through governance reporting Repeated findings occur without evidence of systemic corrective action Audit records contain indexed evidence and verification documentation

Question 6 of 10 Which practice provides the strongest support for an evidence-based audit conclusion?

Relying on the auditor's professional impression of the process Recording evidence using unique identifiers and retaining original extracts Accepting verbal assurances without documenting interviews Reporting a deficiency based only on an isolated assumption

Question 7 of 10 Why should a case-processing sample include both closed and recently processed cases?

To avoid reviewing cases that contain source documentation To assess both completed outcomes and current process performance To ensure that only the oldest cases are included in the audit report To eliminate the need for population-based sampling

Question 8 of 10 Why is trending audit findings across multiple audits important?

It allows the organisation to replace individual finding investigations It identifies recurring or systemic themes that may require broader action It ensures that every audit receives the same finding grade It demonstrates that the audit programme has produced a high number of findings

Question 9 of 10 Which audit scope would most directly evaluate whether delegated safety responsibilities are being controlled effectively?

Vendor oversight and third-party management Office space utilisation Corporate branding review General employee engagement

Question 10 of 10 Which finding classification is most appropriate for a deficiency that creates a significant immediate risk to patient safety or regulatory compliance?

Observation Minor Major Critical

Pharmacovigilance Audits: Knowledge Assessment

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