Pharmacovigilance Audits Knowledge Assessment

Inspections never consider audit results. The organisation's primary objective is sustainable assurance, risk control and patient protection; inspection readiness is an important consequence, not the sole purpose. Audits and inspections are legally identical activities. Inspection readiness requires avoiding documentation of weaknesses.

The process is effective because its SOP is complete. The process cannot be assessed because sampling was used. The process design may be adequate, but operating effectiveness and remediation sustainability are not demonstrated. The findings should be excluded because they relate to historical cases.

A formatting inconsistency in an audit checklist A critical patient safety risk or systemic failure in expedited reporting A report issued one working day later than the internal target A minor observation with no impact and an accepted action plan

One minor observation in a single audit A declining number of completed audits caused by an approved programme change Recurring findings involving the same control across multiple audits or periods A single auditor taking one additional day to issue a draft report

It guarantees that every process will be audited exactly once every three years. It allows balanced coverage, repeat and follow-up audits, and adjustment for emerging risks over time. It eliminates the need for annual risk assessments. It prevents auditors from changing the schedule when significant risks arise.

Marketing materials, product labels and sales forecasts Validation records, role-based access documentation, change-control records and audit-trail review evidence The auditor's travel records and interview invitations Only the current database user manual

A routine annual update to an audit checklist with no process change A significant organisational change affecting responsibilities, reporting lines or the pharmacovigilance system The completion of an audit with no findings A change in the font used in audit reports

Copy all identifiable patient information into every working paper. Avoid retaining any evidence, even where it is necessary to support a finding. Retain necessary evidence with appropriate redaction or anonymisation of patient identifiers and comply with applicable privacy requirements. Send unredacted records to all members of the audit steering committee.

The audit frequency is too high because signal management should only be reviewed after an inspection. A fixed cycle is always prohibited for pharmacovigilance processes. The schedule does not demonstrate risk-based prioritisation or responsiveness to emerging risk. Signal management should be audited only by the QPPV.

Only whether the affiliate uses the same office procedures as headquarters Whether local responsibilities, reporting timelines, training, records and escalation align with both local requirements and global expectations Only whether the affiliate has received a recent corporate presentation Whether the affiliate has the same number of staff as other regions