QA/AI & ML Compliance Services

Comprehensive Support Across Your AI & ML Compliance Journey

Quality & Compliance Interconnected services are designed to ensure compliant, validated, and high-performing digital ecosystems

AI Strategy Development, Readiness & Implementation

Strengthening the foundation for AI success through structured readiness, governance, and implementation support that aligns with business and regulatory objectives.

• Supporting clients on AI adoption and process enhancement
• Enabling faster, smarter decision-making through integrated data and automation
• Building internal AI capability and readiness
• Proactively managing compliance and regulatory expectations

• AI Readiness & Maturity Assessment
• Digital Blueprint Development & Implementation
• High-Impact AI Opportunity Identification
• AI Partnership & Vendor Selection Support
• AI Implementation Support (Business Process Optimization, OCM)
• Governance & Performance Monitoring Frameworks
• AI Compliance & Validation Plan

AI Validation, GxP Compliance & Governance

Ensure your AI/ML tools and algorithms meet stringent GxP, EMA, and FDA regulatory expectations through structured validation and compliance governance.

• Validation of AI/ML applications in GxP processes (Manufacturing, QC, Clinical, etc.)
• Assessment of algorithm training data integrity, bias, and traceability
• Regulatory alignment verification for AI/ML systems in development and manufacturing

• Validation Protocols & Reports
• Algorithm Risk Assessments
• AI/ML Lifecycle SOPs
• Compliance Roadmaps for AI Use Cases

Data Integrity (DI) Compliance Assessments

Safeguard data trustworthiness and compliance during your digital transformation. Our DI experts assess, align compliance, and enhance your data integrity practices across systems and operations.

• End-to-end DI audits for digital systems and applications
• Evaluation of ALCOA+ principles, system controls, audit trails, backup/recovery
• Map gaps vs. FDA/EMA DI guidelines and best practices
• Development of upgrade and remediation strategies

• Current-State DI Maturity Scorecard
• Gap Analysis & Risk Matrix
• Prioritized Remediation Plan
• Updated DI SOPs
• Support for Remediation Execution

Cybersecurity Readiness Audits (GxP Focused)

Identify and mitigate cybersecurity risks in GxP-critical digital systems to protect data integrity, ensure operational continuity, and align with global regulatory expectations.

• Assessment of GxP digital systems (eQMS, eTMF, LIMS, MES, SCADA)
• Evaluation of vulnerabilities and data protection measures

• Cybersecurity Audit Report
• GxP-Specific Cyber Risk Remediation Plan