JAF Consulting offers Quality Assurance as a Service (QAaaS) and is based on the Functional Service Provider (FSP) model, which will benefit organizations by providing increased productivity, flexibility, and scalability of staff, and significant cost savings.

JAF’s team can seamlessly integrate into any organization’s programs as a QAaaS provider. Our team has worked with many different organizations and understands the types of projects we will be called to produce. We have our own internal procedures in which we are trained, or we could utilize your procedures and processes. Our consultants have no less than 10 years of experience as Quality Assurance professionals, we understand compliance and we are able to hit the ground running with any program we are integrated with.

AI/ML Governance, Validation & Regulatory Compliance

Bringing AI Innovation into Regulated Life Sciences with Confidence

Artificial Intelligence and Machine Learning are changing how pharmaceutical, biotechnology, medical device, laboratory, and clinical research organizations operate. However, implementing AI in a regulated environment introduces challenges involving system reliability, data integrity, model performance, human oversight, and regulatory compliance.

JAF Consulting helps organizations evaluate, govern, validate, and maintain AI-enabled technologies in regulated environments.

Our approach combines practical quality assurance experience, risk-based computerized system validation, data integrity principles, and regulatory knowledge to help organizations adopt AI responsibly while maintaining appropriate controls and defensible evidence.

Our AI/ML Consulting Services

AI Governance and Risk Management

• AI governance frameworks, policies, and SOPs
• AI system inventories, classification, and risk assessments
• Defined intended use and accountability
• Human oversight and decision-making controls
• AI supplier qualification and third-party risk management

AI/ML Validation and Assurance

• Risk-based validation and assurance strategies
• Model credibility and performance assessments
• Data quality, provenance, and integrity assessments
• Verification of AI-enabled system functionality
• Monitoring, drift management, and change control

GxP Compliance and Inspection Readiness

• Gap assessments for AI-enabled GxP processes
• Assessment of applicable regulatory requirements
• AI-specific audit programs and supplier evaluations
• Documented evidence of controls and system performance
• Remediation planning and inspection preparation

Generative AI and Enterprise AI Oversight

• Governance of generative AI tools and AI copilots
• Assessment of AI use in quality, regulatory, clinical, and laboratory operations
• Review of AI-generated GxP records and content
• Oversight of AI-supported decisions
• Security, confidentiality, and data integrity risk management

AI Lifecycle and Continuous Assurance

• Governance of model and system changes
• Model performance monitoring and re-evaluation
• Periodic review and continued suitability assessments
• Incident management and escalation
• Training and role-based responsibilities

Supporting Responsible AI Adoption

Whether your organization is evaluating its first AI application or managing multiple AI-enabled GxP systems, JAF Consulting provides independent quality and compliance support throughout the AI lifecycle.

Schedule an AI/ML Compliance Consultation

Discuss your AI implementation, governance requirements, validation challenges, and regulatory risks with JAF Consulting.

When you partner with JAF you receive high-quality services that have earned a reputation for being practical and cost-effective to assist our clients in complying with today’s regulatory requirements.