This AI-based computerized system validation audit checklist provides a structured framework for auditing AI systems in GxP environments. It covers all key areas that auditors should examine and explains how GxP Cellators supports organizations through the audit process.
AI-Based CSV Audit Checklist
1. AI System Inventory and Risk Assessment
- Have all AI applications been identified?
- Is each application documented?
- Has each application been risk assessed?
- Is the risk assessment documented and approved?
2. AI Governance
- Is there a documented governance framework?
- Are roles and responsibilities defined?
- Is there an oversight committee?
- Are AI systems subject to change control?
3. Training Data
- Is training data quality controlled?
- Is training data representative?
- Is there documentation of preprocessing?
- Has training data been reviewed for bias?
4. Model Development
- Is the development methodology documented?
- Are requirements defined and traceable?
- Has the model been validated?
- Are performance metrics appropriate?
5. Model Documentation
- Is the intended use documented?
- Is the architecture documented?
- Are limitations documented?
- Is the version history documented?
6. Human Oversight
- Is there a process for human review?
- Are humans able to override the system?
- Is there documentation of interventions?
- Are personnel trained on AI limitations?
7. Data Integrity
- Are audit trails enabled?
- Are access controls in place?
- Are outputs attributable?
- Are model changes documented?
8. Security
- Is the system protected from unauthorized access?
- Is there protection against adversarial inputs?
- Are security incidents documented?
9. Regulatory Compliance
- Does the system comply with 21 CFR Part 11, where applicable?
- Does the system comply with EU GMP Annex 11, where applicable?
- Is the system compliant with applicable data integrity requirements?
10. Vendor Management
- Has the vendor been qualified?
- Is there a quality agreement?
- Does the vendor provide validation documentation?
- Is there a contingency plan?
How GxP Cellators Supports AI-Based CSV Audits
GxP Cellators provides comprehensive AI-based CSV audit services.
Our AI CSV Audit Services Include
- Full-scope AI-based CSV audits
- Pre-audit readiness assessments
- AI governance framework reviews
- Training data quality audits
- AI model validation documentation reviews
- Human oversight process audits
- Data integrity audits
- AI security assessments
- Regulatory compliance reviews
- Vendor and supplier audits
- Mock AI audits
- CAPA verification and follow-up
Why Choose GxP Cellators?
- Auditors with deep experience in both CSV and AI technologies
- Coverage of FDA, EMA, Health Canada, MHRA, and WHO requirements
- A risk-based approach tailored to your systems
- Practical, actionable reports
- Full confidentiality for your proprietary systems
Frequently Asked Questions
Q1: What should be included in an AI-based CSV audit checklist?
An AI-based CSV audit checklist should cover AI system inventory, governance, training data, model development, model documentation, human oversight, data integrity, security, regulatory compliance, and vendor management.
Q2: How is AI-based CSV different from traditional CSV?
AI-based CSV must address non-determinism, continuous learning, opacity, and data dependency. Traditional CSV focuses on deterministic systems with defined requirements and testing.
Q3: What are common findings in AI-based CSV audits?
Common findings include incomplete AI system inventories, a lack of governance frameworks, inadequate training data documentation, insufficient model validation documentation, and inadequate human oversight.
Q4: How does GxP Cellators support AI-based CSV audits?
GxP Cellators provides full-scope AI-based CSV audits, pre-audit assessments, governance reviews, training data audits, model validation reviews, and mock inspections.
Q5: How do I contact GxP Cellators for AI-based CSV audit support?
You can reach us through our contact page to discuss your AI-based CSV audit requirements.
Contact GxP Cellators
If you need support with AI-based CSV audits, please contact GxP Cellators.
