Our AI auditing services
Our AI auditing and assurance services help life sciences organizations adopt and govern AI with confidence. We provide independent, risk-based assessments tailored to the intended use, complexity, and regulatory impact of each AI application.
Assess & Prepare
- AI Governance Readiness Assessment
- AI Governance Gap Analysis
- ISO 42001 Readiness
- AI Regulatory & Inspection Readiness
Audit & Assure
- AI Vendor Oversight Audit
- AI Assurance & Auditing
- AI Risk Assessments
- AI Continuous Monitoring & Periodic Review
Build & Enable
- Responsible AI Framework Design
- AI Validation & CSA Evidence Pack
- AI Governance Training
AI Governance Readiness Assessment
An independent review of your AI governance framework to evaluate organizational readiness for the compliant deployment and oversight of AI within GxP-regulated environments.
AI Governance Gap Analysis
A structured assessment of existing AI governance arrangements to identify gaps, prioritize remediation activities, and support the development of a fit-for-purpose governance framework.
AI Vendor Oversight Audit
A risk-based evaluation of AI suppliers, including their governance, quality management systems, and controls, to strengthen oversight beyond traditional vendor qualification practices.
AI Validation/CSA Evidence Pack
Development of a structured validation and assurance package demonstrating that AI technologies have been appropriately assessed, validated, and controlled in line with risk-based validation principles and Computer Software Assurance (CSA) expectations.
AI Assurance and Auditing
An independent assessment of AI systems, supporting processes, and governance controls to evaluate compliance, quality, transparency, and operational effectiveness. The review provides objective evidence that AI technologies are deployed, managed, and monitored in accordance with GxP expectations and risk-based quality principles.
ISO/IEC 42001 Readiness Assessment
An evaluation of your AI management system against the requirements and principles of ISO/IEC 42001, identifying opportunities to strengthen governance, accountability, and continual improvement.
AI Regulatory & Inspection Readiness
Preparation for regulatory inspections and internal audits through assessment of AI governance, model transparency and explainability, vendor oversight, data lineage, performance monitoring, and human oversight controls.
AI Governance Training
Practical training programs designed to build awareness and competence across operational, quality, and leadership teams, helping them understand AI governance principles, emerging regulations, and industry expectations.
Responsible AI Framework Design
Design and implementation of practical governance frameworks that support the safe, transparent, ethical, and accountable use of AI across its lifecycle.
AI Risk Assessments
Independent, risk-based assessments of AI applications to identify quality, compliance, operational, and business risks, enabling informed decision-making and proportionate control strategies.
