Computerized System Validation (CSV)

CSV Strategy & Validation Planning

User Requirements Specification (URS)

CSV Strategy & Validation Planning

A flowchart illustrating the validation process.

 Development of risk-based validation approaches, plans and documentation.

GAMP 5 Risk Assessments

User Requirements Specification (URS)

CSV Strategy & Validation Planning

Person reviewing financial charts on a clipboard.

 Assessment of computerized systems based on intended use, complexity and GxP impact.

User Requirements Specification (URS)

User Requirements Specification (URS)

User Requirements Specification (URS)

Hand in white shirt writing on glass with reflections.

 Preparation and review of user requirements and system specifications.

Validation Testing (IQ/OQ/PQ)

Traceability Matrix & Validation Reports

User Requirements Specification (URS)

Checklist and quality approval icons in a sequence with magnifying glass.

Preparation and execution support for installation, operational and performance qualification.

Traceability Matrix & Validation Reports

Traceability Matrix & Validation Reports

Traceability Matrix & Validation Reports

Diagram showing key aspects of software quality.

 Documentation linking requirements, risks, testing and validation results.

Data Integrity & Electronic Records

Traceability Matrix & Validation Reports

Traceability Matrix & Validation Reports

 Assessment of data integrity controls, electronic records and electronic signatures.