Computerized systems validation: a mandatory condition for Data Integrity

This activity defines the scope of computerized system validation and presents the associated documentation requirements, such as the Validation Master Plan.It introduces fundamental concepts including computerized systems, system lifecycle, and critical systems.

This activity explores the left side of the V-cycle.It details key steps such as user requirements definition, system criticality analysis, supplier audits, and expected deliverables such as the traceability matrix, design qualification report, and functional risk analysis.

This activity covers the right side of the V-cycle, corresponding to the verification and execution phases.It describes qualification tests (IQ-Installation Qualification, OQ-Operational Qualification, PQ-Performance Qualification), compliance requirements to be validated, and the deliverables required prior to system authorization.

This activity presents the measures required to maintain a computerized system in a validated state.It is based on four real-life cases illustrating the appropriate responses to critical situations or identified deviations.