Computerized System Validation (CSV)

• 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
   

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.

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

• 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