Auria Consulting Group offers specialized services in data integrity and AI integration to help pharmaceutical and life sciences companies modernize their quality systems while maintaining robust regulatory compliance. As agencies heighten expectations around data governance and digital technologies reshape GxP environments, we guide clients through the twin imperatives of compliance and innovation. Our data integrity solutions focus on identifying system vulnerabilities—whether in paper records or electronic platforms—and implementing remediation strategies that strengthen controls, promote accountability, and align with global standards. In parallel, we support the compliant adoption of AI and digital tools, helping organizations leverage automation, predictive analytics, and intelligent systems within validated, auditable frameworks. From assessing risks to enabling digital transformation, we ensure clients advance with both confidence and control.

Our data integrity and AI integration capabilities include, but are not limited to:

• Data integrity audits across digital and paper-based systems

• Gap assessments aligned with FDA, EMA, and MHRA expectations

• Remediation planning and execution for ALCOA+ compliance

• Governance frameworks for data integrity monitoring and oversight

• Training programs to promote awareness and accountability

• Risk-based validation and lifecycle management of digital tools

• Strategy development for GxP-compliant AI implementation

• AI readiness assessments and use case prioritization

• Documentation and support aligned with GAMP 5 principles

• Oversight of AI model transparency, auditability, and performance monitoring

We help you modernize with purpose—balancing innovation and compliance to build systems that are both future-ready and regulator-trusted.