GxP Computerized Systems Validation
Explore the critical concepts of Computerized Systems Validation (CSV) in regulated life sciences industries, including pharmaceuticals and medical devices. Delve into essential aspects like system lifecycle, risk assessment, and regulatory requirements such as FDA’s 21 CFR Part 11. The module covers how to ensure computerized systems remain ‘fit for use’ to uphold product quality, patient safety, and data integrity.
Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.
Duration: 30 Mins
Grade: Core Library
Description
- Robust Understanding of Computerized Systems in Regulated Environments: Develop a foundational comprehension of computerized systems, including their role and impact in GxP regulated environments.
- Facilitate Compliance with Industry Regulations: Learn practical methods for validating systems in line with crucial regulations such as 21 CFR Part 11 and understand the consequences of non-compliance, including regulatory audits and potential penalties.
- Proficiency in CSV Risk Management and Lifecycle Approaches: Acquire the skills to evaluate risks associated with computerized systems and integrate validation into the system’s lifecycle, ensuring consistent compliance and operational integrity.
- Practical Knowledge of CSV Implementation and Documentation: Gain insights into planning, specifying, configuring, and verifying computerized systems. Recognize the importance of complete and accurate documentation to ensure system reliability and regulatory proof during inspections.
Learning Objectives
- Define ‘computerized system’.
- Explain the purpose of computerized system validation.
- Explain the purpose of the 21 CFR Part 11 regulation.
- Define ‘risk’ as it relates to computerized systems.
- Describe how software in computerized systems is categorized.
- Explain the purpose of incorporating CSV into the system life cycle approach.
- Describe the activities involved in the project phase of CSV.
- Explain why risk management must be done throughout the operating phase of a computerized system.
Keywords
- Computerized Systems Validation (CSV)
- Data integrity
- FDA 21 CFR Part 11
- Good Clinical Practices (GCP)
- Good Laboratory Practices (GLP)
- Good Manufacturing Practices (GMP)
- GxP regulations
- Risk assessment
- System lifecycle
- Validation documentation
Module Features
Animations
Voice Over
Knowledge Checks
Assessments
SCORM/AICC compatible
Full Screen