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Overview
Key module objectives
Being able to recognize Data Integrity governance, roles and methodology, and to apply ALCOA+ principles.
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: Application of ALCOA+ principles
• Attributable
• Legible
• Contemporaneous
• Original
• Accurate
• Available
• Complete
• Consistent
• Enduring
Activity #2: Methodology: how to apply the Data Integrity requirements?
• Top Management awareness
• Data Integrity Governance
• Data Integrity Risk Assessment (DIRA)
• Data Integrity and remediation
• Monitoring indicators
Activity #3: Data Integrity implementation challenges and associated solutions
• Electronic case
• Audit Trail challenges
• Rights Matrix challenges
• Other challenges
• Paper case
• Controlled forms management
• Rounding rules
• Archiving of paper records
Prerequisites
No prerequisites
Learning mode
Remote
Digital modalities
Activity 1: E Learning / Activity 2: Serious Game 2D / Activity 3: Serious Game 2D
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
N/A
Contact for any question
Module Version Level & Date
Advanced level, Gold Version from 10/06/2024
Accessibility & Disability
The courses of this Module meet WCAG standards.
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