Introduction
AI software compliance audits must address three critical areas: data integrity, validation, and documentation. This blog explains each area in detail and explains how GxP Cellators supports pharmaceutical companies through the audit process.
Data Integrity for AI Software
Data integrity is the foundation of GxP compliance. For AI systems, data integrity applies to both training data and operational data.
Training Data Integrity:
- Is training data sourced from reliable sources
- Is training data representative of intended use
- Has training data been assessed for completeness
- Is there documentation of data preprocessing
- Has training data been reviewed for bias
Operational Data Integrity:
- Are audit trails enabled for AI inputs and outputs
- Are access controls in place
- Are model changes documented and approved
- Are AI outputs attributable
- Is data legible, contemporaneous, original, and accurate
Validation for AI Software
Validation ensures that AI software is fit for purpose.
Validation Requirements:
- Define intended use and requirements
- Document model development methodology
- Validate against predefined acceptance criteria
- Test with independent validation data
- Document model limitations and assumptions
- Implement ongoing performance monitoring
Documentation for AI Software
Documentation is essential for regulatory acceptance and ongoing maintenance.
Key Documentation:
- System requirements specification
- Validation plan and report
- Model development documentation
- Training data documentation
- Risk assessment
- Standard operating procedures
- User manuals and training materials
- Change control records
- Audit trails and access control records
How GxP Cellators Supports AI Software Compliance Audits
GxP Cellators provides comprehensive AI software compliance audits covering data integrity, validation, and documentation.
Our AI Software Compliance Audit Services Include:
- Data integrity audits for AI systems
- Validation documentation reviews
- AI model validation audits
- Training data quality audits
- Documentation completeness reviews
- Regulatory compliance reviews
- Mock AI audits
- CAPA verification and follow up
Why Choose GxP Cellators:
- Auditors with deep experience in GxP and AI technologies
- Coverage of FDA, EMA, Health Canada, MHRA, and WHO requirements
- Risk based approach tailored to your AI applications
- Practical, actionable reports
- Full confidentiality for your proprietary systems
Frequently Asked Questions
Q1: What is data integrity for AI software?
Data integrity for AI software means that data used to train and operate AI systems is accurate, complete, and protected from unauthorized changes. It applies to both training data and operational data.
Q2: What validation is required for AI software?
Validation for AI software includes defining intended use and requirements, documenting model development, validating against acceptance criteria, testing with independent data, documenting limitations, and implementing ongoing performance monitoring.
Q3: What documentation is required for AI software compliance?
Required documentation includes system requirements, validation plan and report, model development documentation, training data documentation, risk assessment, standard operating procedures, user manuals, change control records, and audit trails.
Q4: How does GxP Cellators support AI software compliance audits?
GxP Cellators provides data integrity audits, validation documentation reviews, model validation audits, training data quality audits, and documentation completeness reviews.
Q5: How do I contact GxP Cellators for AI software compliance audit support?
You can reach us through our contact page at /contact/ to discuss your AI software compliance audit requirements.
Contact GxP Cellators
If you need support with AI software compliance audits, please contact GxP Cellators.
Contact: /contact/
