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Quality Management > Intermediate
AI-Powered Quality Assurance, Computer System Validation (CSV/CSA), and AI Auditing
A practical guide to quality assurance and computer system validation in an AI-enabled life sciences environment. Covers GxP regulatory frameworks (21 CFR Part 11, GAMP 5, Annex 11), the shift from scripted CSV to risk-based Computer Software Assurance (CSA), auditing AI/ML training data for ALCOA+ integrity and bias, validating and monitoring AI/ML models in production, and governing generative AI with human-in-the-loop controls. Closes with AI vendor qualification, change control, and inspection readiness for AI-enabled quality systems. Built for QA and validation professionals bringing AI into a GxP environment without losing control of it.
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What you'll learn
- Explain core GxP regulatory frameworks (21 CFR Part 11, GAMP 5, Annex 11) and how AI changes the QA landscape
- Apply risk-based Computer Software Assurance (CSA) in place of traditional scripted CSV testing
- Audit AI/ML training data and datasets for ALCOA+ data integrity, bias, and version control
- Validate and monitor AI/ML models in production, including drift detection and retraining triggers
- Govern generative AI use in regulated workflows, including prompt validation and human-in-the-loop gates
- Qualify and audit AI vendors and SaaS providers against GxP requirements
- Manage change control, documentation, and inspection readiness for AI-enabled quality systems
Course content
Welcome and Course Roadmap
Defining GxP in the Era of Artificial Intelligence
The Role of Quality Assurance (QA) in Modern Life Sciences
Core Regulatory Frameworks: 21 CFR Part 11, GAMP 5, and Annex 11
Building an AI-Quality Culture: Mindset over Paperwork
The Limits of Traditional Computer System Validation (CSV)
Requirements
- Basic familiarity with GxP, quality systems, or computer system validation is helpful but not required
- No coding or AI development experience needed
Description
A practical guide to quality assurance and computer system validation in an AI-enabled life sciences environment. Covers GxP regulatory frameworks (21 CFR Part 11, GAMP 5, Annex 11), the shift from scripted CSV to risk-based Computer Software Assurance (CSA), auditing AI/ML training data for ALCOA+ integrity and bias, validating and monitoring AI/ML models in production, and governing generative AI with human-in-the-loop controls. Closes with AI vendor qualification, change control, and inspection readiness for AI-enabled quality systems. Built for QA and validation professionals bringing AI into a GxP environment without losing control of it.
This course is designed for:
- QA, validation, and compliance professionals adapting to AI-enabled systems
- Computer system validation (CSV/CSA) specialists transitioning to risk-based, AI-aware approaches
- Auditors and quality leaders responsible for AI vendor and model oversight
Instructor
SafeMeds Academy
Life-science curriculum specialist
Practical training for pharma, biotech, CRO, regulatory, clinical, PV, market access, medical writing, data, and AI-enabled teams across the globe.
How to earn your certificate
- Watch the lessons. Each lesson is marked complete automatically once you have watched 90% of its video — there is no button to click.
- Reach 100%. When all 42 lessons are complete, the final quiz unlocks in your course player and dashboard.
- Pass the final quiz. 20 multiple-choice questions, 70% to pass (14/20), with unlimited retries.
- Get your certificate. It is issued to your account automatically, emailed to you, and verifiable online.