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Overview
Key module objectives
Being able to explain how a computerized systems is validated, and how it is maintained in a validated state.
Target audience
Employees or newcomers in pharmaceutical or chemistry or biotechnolgies industries
Operators, techniciens and Managers from production areas and IT support
Technicians and Managers from Quality Control laboratories
Quality Assurance personnels
Module Overview
Activity #1: Basics of validation of computerized systems
• The perimeter
• Validation
• Validation Master Plan
• Computerized system
Activity #2: Specification steps of validation of computerized systems process
• V-Cycle
• User Requirment Specification
• System Criticality Assessment
• Supplier Audit and Qualification
• Validation Plan
• Functional Specifications - Design Specifications
• Traceability Matrix
• Design Qualification Report
• Functional Risk Assessment
• Build Phase
Activity #3: Validation of computerized system: verification phase
• Installation Qualification in Test Environment
• Operational Qualification in Test Environment
• Installation Qualification in Production Environment
• Authorization for Use
• Performance Qualification
• Validation Report
Activity #4: Maintaining a computerized system in a validated state
• Incident Management, Change Control, and Business Continuity Plan
• Periodic Review
• Audit Trail Review
• Data Integrity Risk Assessment (DIRA)
Prerequisites
No prerequisites
Learning mode
Remote
Digital modalities
Activity 1: E LEarning / Activity 2: Serious Game 2D / Activity 3: Serious Game 2D / Activity 4: Serious Game 3D
Evaluation procedures
• A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one (no limit of attempts, 80% of correct answers required).
• Trainees enrolled in the whole curriculum have the possibility to assess and set their new knowledges and skills via an anchoring quiz between modules.
Required equipment
Recommended equipment for an optimal experience : PC computer, with the last version of web browsers Chrome/Firefox/Microsoft Edge, and an internet connection of 8 Mb/s or more.
Face to face training
Some activities on this curriculum must be done within an Immerscio Training Center. Please consult the available Immerscio Training Centers and the onsite reservation modalities HERE.Â
Contact for any question
Module Version Level & Date
Advanced level, Gold Version from 29/06/2024
Accessibility & Disability
The courses of this Module meet WCAG standards with the exception of contents in 3D. For those contents, alternatives can be proposed to the Trainee. For any questions or additional information, please contact support@immerscio.com.
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