ICH E6(R3) - Good Clinical Practice 4.3-validation: Own validation status across the life cycle with a risk-based approach that shows completeness, accuracy, reliability and consistent performance, validating before use, after risk-assessed changes, configurations, customisations, interfaces and critical functions, with periodic review, retained documentation and justified unresolved issues

What does 4.3-validation require?

The responsible party owns each system's validation status throughout its life, using a risk assessment of intended use, what the data or records are for and how important they are and the system's potential effect on participants and results. Validation should show that the system satisfies its completeness, accuracy and reliability requirements and performs consistently for its purpose; systems should be validated before use, with later changes validated by risk under change control considering existing and new data, and periodic review where appropriate. Standard functionality and protocol-specific configuration and customisation (including automated checks and calculations) and system interfaces should be validated, with the degree varying for bespoke, configurable or unaltered systems; procedures should run from design and requirements through functional testing, configuration, release, setup and installation to change control and decommissioning; systems developed by others should be shown fit for purpose and documentation kept; validation should define and test requirements, especially for critical functions such as randomisation, dosing and titration and endpoint collection; and unresolved issues should be justified and their risks mitigated.