Détails de la formation

Computerized System Validation (CSV)

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Objectifs

  • Identify applicable regulatory requirements and guidelines, including GAMP 5 and 21 CFR Part 11

  • Explain the complete lifecycle of a computerized system in the pharmaceutical industry

  • Apply a risk-based approach to structure a compliant validation strategy

  • Develop the main CSV deliverables (URS, risk analysis, IQ/OQ/PQ protocols, validation report)

  • Implement best practices for the operational management of computerized systems and data integrity
     

Public cible

Staff involved in the validation of computerized systems in a pharmaceutical environment, including QA, IT, automation engineers, qualification and validation specialists, process owners, and production managers.

Conditions de participation

Basic knowledge of the pharmaceutical environment and quality processes is an asset.

Programme

  • Introduction to Computerized System Validation

    • Role of computerized systems in pharmaceutical development and production

    • Types of systems: equipment, automated systems, and infrastructure

    • Fundamental principles of computerized system validation

  • International Regulations and Standards

    • Main regulations and guidelines applicable to CSV

    • GMP requirements and their impact on computerized systems

    • Health authorities’ expectations regarding IT compliance

  • Data Integrity and CSV Fundamentals

    • ALCOA+ principles and data integrity requirements

    • Lifecycle stages of a computerized system

    • Fundamentals of GAMP®5 and the risk-based approach

  • Case Study: Design Phase

    • Structuring a CSV project and defining roles and responsibilities

    • Design and specification documents: URS, FS, and DS

    • Risk analysis and validation planning

  • Case Study: Validation and Qualification Phase

    • Documentation and testing best practices

    • IQ, OQ, and PQ activities within a CSV project

    • Validation report preparation according to regulatory expectations

  • Operational Phase and Decommissioning

    • Change management, deviations, CAPAs, and periodic reviews

    • Continuity, security, and records management

    • Decommissioning and data migration of computerized systems