VALIDAÇÃO DE SISTEMAS INFORMÁTICOS

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Análise dos processos inerentes ao CSV e das novas tecnologias com o novo enfoque GAMP®5 2nd ed. (CSV in cloud solutions, Agile , DevOps, Computer software assurance, AI and Machine Learning in GxP )

Análise das  implicações do processo de CSV com a garantia de qualidade e fabrico ,tendo em consideração as guidelines de qualidade e/ou legislação aplicáveis

PROGRAMA

Overview of Computerized System Validation (CSV)

Regulatory framework for CSV ACTIVITIES

• Autoridades e organizações
• EUDRALEX Volume 4
• Key concepts
• Chapter 1. Pharmaceutical Quality System
• Chapter 5. Production
• Annex 11. Key concepts. Updates and Statements
• Risk Management
• Personnel
• Suppliers ans Service providers
• Validation
• Data
• Accuracy checks
• Data Storage
• Printouts
• Audit trails
• Change and configuration management
• Periodic evaluation
• Security
• Incident management
• Electronic signature
• Batch release
• Business continuity
• Archiving
• Annex 15 . Qualification and Validation
• FDA 21 CFR Part 11
• Implement a QMS compliant with Part 11

GAMP®5 2nd edition risk-based approach

• Key concepts
• Process and product understanding
• Life Cycle Approach within a QMS
• Software/system categories; Hardware categories
• Multi-category System
• Science-based Quality Risk Management
• Leveraging supplier involvement
• Life cycle Phases
• Risk Assessment
• Failure mode and effects análisis
• The V-Cycle
• Validation activities and Documentation
• Incident management and CAPA process
• Business continuity vs Disaster Recovery
• Audit Trail and review process
• Records management process
• Data integrity compliance

Overview of new technologies in highly regulated enviroment

The use of technology and new approach following GAMP®5 2nd ed.

• Data Integrity by design
• CSV in cloud solutions
• Modern Software engineering ( Agile ; DevOps )
• Computer software assurance
• AI and Machine Learning in GxP

An industry perspective