QPPV.COM KNOWLEDGE ASSESSMENT

Business Continuity and Disaster Recovery in Pharmacovigilance

Test your understanding of the concepts covered by Business Continuity and Disaster Recovery in Pharmacovigilance.

Question 1 of 10Pass mark: 80%

Question 1 of 10 During continuity mode, a team focuses first on serious and deadline-sensitive cases. Which additional control best ensures that prioritisation does not become loss of oversight?

Keep the remaining workload visible with status, owner, received time, deadline or due date, next action and escalation status. Remove routine cases from the log until capacity returns. Record only the number of cases deferred, not their individual status. Allow each processor to decide independently whether lower-priority items remain in scope.

Question 2 of 10 When reviewing its continuity framework, an MAH asks whether EU rules prescribe a single recovery time objective and exercise frequency. What is the most accurate response?

EU rules prescribe the same recovery time and exercise frequency for all MAHs. The MAH must provide appropriate instructions for urgent processes, including business continuity, while setting implementation choices through risk-based planning. A recovery time objective is mandatory only if the MAH operates its own safety database. The MAH may omit continuity instructions if its critical vendor has a disaster-recovery plan.

Question 3 of 10 An exercise meets its planned schedule but misses the objective of reconciling every test item. What is the best next step?

Record the exercise as successful because it was completed as planned. Assess the result against the objective, identify the cause of the gap, assign corrective action and retest the affected capability. Remove reconciliation from future exercise objectives. Repeat the same exercise without documenting the missed objective.

Question 4 of 10 A technical failover test succeeds, but no PV staff tested intake, triage or backlog reconciliation. What conclusion is justified?

The end-to-end continuity capability is proven because the system recovered. All PV obligations can be met because a technical target was achieved. The test provides evidence about technical recovery, but not whether PV processes and work reconciliation will function. The test is invalid because technical recovery should never be tested separately.

Question 5 of 10 What is the most appropriate way to reconcile work performed during downtime with a restored safety system?

Transfer the temporary records, link their temporary identifiers to permanent records, check duplicates and attachments, and resolve discrepancies against a defined reconciliation population. Compare only the total number of temporary records with the total number of restored cases. Delete the temporary log once records have been entered, without retaining transfer evidence. Reconcile only serious cases because other records do not affect continuity.

Question 6 of 10 After a system is technically restored, which action best supports its safe return to regulated PV use?

Rely on the vendor's statement that the infrastructure is online. Resume all processing once users can log in, without checking interfaces or records. Perform checks appropriate to the service, such as access controls, data integrity, audit trail, interfaces and representative processing, and apply change control or validation if needed. Wait until the next routine audit to determine whether the system is fit for use.

Question 7 of 10 During an inspection, which evidence most convincingly demonstrates that continuity is an operational capability rather than only a policy statement?

A policy that states the organisation has business continuity arrangements. A vendor contract containing a general commitment to restore services. A statement that the organisation has never experienced a major outage. A connected evidence trail including the impact assessment, procedures and roles, exercise or incident records, downtime handling, recovery checks, reconciliation and corrective-action closure.

Question 8 of 10 An outage affects an electronic reporting channel. Which communication approach is most appropriate?

Assume that every outage must be notified to every competent authority immediately. Create a new submission route to the authority without checking its instructions. Treat the outage as automatically exempting affected reports from submission. Assess notification under applicable rules and procedures, consult the channel owner's current official instructions, and avoid inventing an alternative route.

Question 9 of 10 A service has an RPO that could leave several hours of new intake absent from the last recoverable database copy. What additional control is most directly needed?

A decision to extend all case-reporting timelines by the RPO. A controlled alternate intake route that captures reports received during the potential data gap. A rule to re-enter reports using the date the database is restored. A technical failover test that does not involve PV staff or intake records.

Question 10 of 10 A team has transferred most downtime items but cannot match one report to a restored record. What should it do?

Treat the item as reconciled if the overall case count matches. Investigate the unmatched item individually and document the impact assessment and disposition. Assign it the next available case number and close the incident. Remove it from the temporary log to prevent a duplicate.

Business Continuity and Disaster Recovery in Pharmacovigilance

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