QPPV.COM KNOWLEDGE ASSESSMENT

Computerised System Validation Plan Knowledge Assessment

Test your understanding of the concepts covered by Computerised System Validation Plan.

Question 1 of 10Pass mark: 80%

Question 1 of 10 What is the main value of a Traceability Matrix?

It records only system installation activities It demonstrates relationships among requirements, risks, specifications, validation activities, evidence and approved changes It replaces the need for acceptance criteria It serves as the organisation's cybersecurity policy

Question 2 of 10 Which content would generally be inappropriate for the main body of a Validation Plan?

The approach to risk-based testing Roles and approval responsibilities Detailed technical instructions for configuring a database field The strategy for maintaining the validated state

Question 3 of 10 Why should interfaces be explicitly included in system scope and risk assessment?

Interfaces are always managed entirely by the primary application Interface failures can affect data integrity and regulated processes beyond the primary application Interfaces are non-regulated by definition Including interfaces removes the need to test end-to-end workflows

Question 4 of 10 For a SaaS pharmacovigilance platform, which responsibility normally remains with the regulated organisation?

Maintaining the supplier's data-centre hardware Developing the supplier's core application code Defining intended use, validating local configuration and workflows, and assessing supplier releases Performing the supplier's internal software-development audits

Question 5 of 10 Which situation best demonstrates that validation planning is driven by intended use?

Testing every available software feature to the same depth Selecting validation activities based on the regulated pharmacovigilance processes the organisation will perform Using the supplier's marketing description as the organisation's requirements Limiting validation to installation because the software is commercially available

Question 6 of 10 What is the most appropriate use of quality risk management in validation planning?

To eliminate testing for functions that are difficult to validate To determine where validation effort, evidence and lifecycle controls should be concentrated To ensure that all functions receive exactly the same documentation To transfer responsibility for validation decisions to the supplier

Question 7 of 10 Which approach best reflects appropriate use of supplier validation evidence?

Accept all supplier evidence without review because the supplier developed the system Reject all supplier evidence and repeat every supplier test locally Evaluate supplier evidence for applicability and use it to complement, but not replace, validation of organisation-specific configuration and workflows Use supplier evidence only for unrelated administrative functions

Question 8 of 10 A significant system change expands a safety database from case processing to support a new aggregate reporting process. What should be assessed first?

Whether the existing intended use, requirements, risks and validation scope remain adequate Whether the supplier's user interface uses the same colour scheme Whether all historical test scripts can be discarded Whether the QPPV should execute the configuration personally

Question 9 of 10 Which statement best characterises inspection readiness in the context of validation planning?

Inspection readiness is a separate exercise performed only after an inspection is announced Inspection readiness is supported by maintaining consistent, current and retrievable evidence throughout the lifecycle Inspection readiness depends mainly on having a large number of test scripts Inspection readiness requires excluding supplier activities from the Validation Plan

Question 10 of 10 Which deliverable normally provides the formal conclusion and production-release recommendation after validation activities are completed?

Risk Assessment Configuration Specification Validation Report User Requirements Specification

Computerised System Validation Plan Knowledge Assessment

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