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Validation Testing in Pharmacovigilance: IQ, OQ, PQ and User Acceptance Testing

Test your understanding of the concepts covered by Validation Testing in Pharmacovigilance: IQ, OQ, PQ and User Acceptance Testing.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which scenario is most suitable for PQ of a pharmacovigilance system?

Checking the installed middleware version Testing a single mandatory field in isolation Processing a partner-transferred case through triage, medical review, quality review, regulatory submission and acknowledgement handling Reviewing the supplier's generic release notes

Question 2 of 10 Which test best represents challenge testing of a critical access control?

Logging in with an authorised account and opening the home page Recording the application version in the installation record Attempting to access regulated safety data using a role without the required privilege Asking users whether they find the access process convenient

Question 3 of 10 Which statement best distinguishes PQ from UAT?

PQ focuses on technical installation, whereas UAT focuses on database configuration PQ demonstrates effective performance of the integrated operational process, whereas UAT documents business acceptance of the solution PQ is always performed by suppliers, whereas UAT is always performed by inspectors PQ uses no realistic data, whereas UAT must use production data

Question 4 of 10 Which feature most improves the scientific defensibility of predefined acceptance criteria?

They are measurable, objective and directly linked to approved requirements They are drafted after the tester observes the system behaviour They allow the tester to decide subjectively whether the outcome is acceptable They describe only the purpose of the test without specifying an expected outcome

Question 5 of 10 When is regression testing most appropriately considered after a validation deviation?

When a correction or change could affect previously validated functionality Only when the original test had no acceptance criteria Whenever a user requests a cosmetic interface change, regardless of impact Never, because retesting the failed step is sufficient

Question 6 of 10 A failed validation test is repeated until it passes, with no deviation recorded. Why is this practice unacceptable?

A failed test automatically proves the supplier is noncompliant The original unexpected result may indicate a defect, process problem or unreliable evidence that requires investigation Retesting is prohibited in validation Only successful results are relevant to patient safety

Question 7 of 10 An organisation implements a commercial safety database with local workflows, custom partner interfaces and organisation-specific reporting rules. How should supplier evidence be used?

It should replace all local testing because the product is commercial It should be ignored because only internally generated evidence is valid It may be leveraged for applicable generic capabilities, while local configuration, interfaces and workflows are verified separately It should be copied without review to preserve supplier consistency

Question 8 of 10 A new MedDRA version is introduced into a validated system. What is the most appropriate validation response?

Perform no testing because dictionary changes are never regulated Repeat the entire original validation package regardless of risk Perform targeted, risk-based testing of affected coding, workflows, reports and interfaces Test only whether users can log in after the update

Question 9 of 10 Which activity most directly belongs to Installation Qualification?

Confirming that a serious case can proceed through medical review and reporting Verifying that the supported database version, certificates and required software components are installed Confirming that business users accept the workflow for production Demonstrating that a complete partner case exchange works end to end

Question 10 of 10 What is the primary purpose of User Acceptance Testing?

To verify infrastructure installation To provide formal business confirmation that the implemented solution is suitable for routine use To replace OQ testing of configured functionality To prove that no software defects remain

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Validation Testing in Pharmacovigilance: IQ, OQ, PQ and User Acceptance Testing

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