QPPV.COM KNOWLEDGE ASSESSMENT

PSMF Oversight

Test your understanding of the concepts covered by PSMF Oversight.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which approach best supports oversight of a critical PV vendor such as a safety database provider?

Rely solely on the vendor's reputation and avoid auditing it Maintain contractual PV obligations, SLAs or KPIs, due diligence, periodic oversight, escalation arrangements and continuity evidence List the vendor in the PSMF but exclude its responsibilities to protect confidentiality Allow the vendor to determine the MAH's PV responsibilities

Question 2 of 10 An MAH has updated its safety database but has not reviewed the PSMF. What is the principal oversight concern?

The PSMF may no longer accurately describe a critical PV system and its validation, interfaces or continuity arrangements The PSMF can only be changed after the next annual review date Only the product list is affected by a safety database change The change is relevant only to IT and does not require QPPV involvement

Question 3 of 10 Which KPI would most directly measure the organisation's ability to respond to a remote inspection request?

Number of medicinal products in the portfolio Time taken to assemble the remote inspection pack or provide requested PSMF evidence Number of pages in the organisational chart Percentage of employees with non-PV training

Question 4 of 10 Which information belongs primarily in the organisation and personnel section of the PSMF?

A list of all product marketing authorisation numbers The PV organisation chart, roles, deputies, local PV leads and competence-management approach The complete text of every individual case safety report Only the names of external auditors

Question 5 of 10 A vendor hosts PV data outside the MAH's primary country. Which PSMF oversight approach is most appropriate?

Ignore the hosting location because the vendor owns the infrastructure Document hosting and transfer arrangements, relevant data protection agreements and controls supporting confidentiality and data integrity Remove the vendor from the PSMF to avoid regulatory attention Document only the vendor's invoicing arrangements

Question 6 of 10 Which statement best explains why archived PSMF versions should be retained?

They are useful only for preparing marketing materials They provide an auditable history of what the PV system description contained and why changes were made They allow obsolete procedures to remain operational They eliminate the need to document current approvals

Question 7 of 10 What is the appropriate minimum expectation for periodic PSMF review described in the article?

A complete review at least annually, supplemented by risk-based targeted reviews or trigger-based updates A complete review only when an inspection is announced A review every five years regardless of system changes A review only when the QPPV changes

Question 8 of 10 What is the principal value of a cross-reference table linking PSMF sections to SOPs, annexes and system records?

It allows supporting evidence to remain unapproved It provides inspectors and internal reviewers with a quick, traceable route from system descriptions to evidence It removes the need for document version control It ensures that all PV activities are performed by one department

Question 9 of 10 What governance model best supports accurate and sustainable PSMF maintenance?

A single document administrator working without input from other functions A designated owner or governance committee with defined contributions from PV, QA, Regulatory Affairs, IT, Legal and local or commercial functions A vendor-controlled model in which the MAH reviews the PSMF only after inspections A model in which the QPPV performs every update personally

Question 10 of 10 What is the main purpose of documenting interfaces with Regulatory Affairs, IT, Legal, Clinical and Commercial functions in the PSMF?

To demonstrate how PV responsibilities and dependencies operate across the wider organisation To replace all cross-functional procedures To show that those functions are legally responsible for the entire PV system To limit the PSMF to activities performed by the central safety department

PSMF Oversight

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