Computer System Validation

Course Design: Computer System Validation (CSV) Course Overview This course is designed to provide a comprehensive understanding of Computer System Validation (CSV) principles and practices. It covers the essential elements of a robust CSV program, including risk assessment, design verification, installation qualification, operational qualification, and performance qualification. Participants will learn how to develop and implement effective CSV strategies to ensure the quality, safety, and compliance of computer systems in regulated industries. Target Audience Quality Assurance professionals Validation engineers Regulatory affairs specialists IT professionals Project managers Anyone involved in the life cycle of computer systems in regulated industries Course Objectives Upon completion of this course, participants will be able to: Understand the regulatory requirements for CSV Perform risk assessments to identify critical system components and processes Develop and execute comprehensive validation plans Conduct effective design verification and installation qualification activities Implement robust operational qualification and performance qualification procedures Maintain and update validation documentation Respond to regulatory audits and inspections Course Outline Module 1: Introduction to Computer System Validation Definition and scope of CSV Regulatory requirements (e.g., 21 CFR Part 11, GAMP 5) Key principles of CSV Benefits of a robust CSV program Module 2: Risk Assessment Risk assessment methodologies (e.g., FMEA, HAZOP) Identifying critical system components and processes Assessing risk levels and prioritizing validation activities Developing risk mitigation strategies Module 3: Validation Planning Developing a comprehensive validation plan Defining validation phases and activities Establishing timelines and resource allocation Creating a validation master plan Module 4: Design Verification Verifying system design against functional and user requirements Reviewing system architecture, software design, and hardware specifications Assessing system security and data integrity controls Module 5: Installation Qualification (IQ) Verifying the correct installation of hardware and software components Testing system connectivity and configuration Ensuring compliance with site-specific standards and procedures Module 6: Operational Qualification (OQ) Verifying that the system operates as intended under defined conditions Testing system functionality, accuracy, and precision Documenting OQ results and deviations Module 7: Performance Qualification (PQ) Verifying that the system performs as intended in a real-world environment Conducting user acceptance testing (UAT) Monitoring system performance over time Module 8: Validation Documentation Creating and maintaining accurate and complete validation documentation Organizing validation records and reports Archiving validation documents Module 9: CSV Lifecycle Management Change control procedures Periodic review and revalidation Retirement and decommissioning of systems Module 10: Regulatory Compliance and Audits Preparing for regulatory inspections and audits Responding to audit findings and corrective actions Maintaining compliance with evolving regulations Delivery Methods Instructor-led training: In-person classroom sessions with hands-on exercises and case studies Virtual training: Live online sessions with interactive elements Self-paced e-learning: Online modules with quizzes and assessments Assessment Knowledge assessments: Quizzes and exams to evaluate understanding of key concepts Practical exercises: Hands-on simulations of validation activities Case studies: Analysis and discussion of real-world CSV scenarios Final project: Development of a comprehensive validation plan for a specific computer system