Computer System Validation and Regulatory Readiness Advisory

Felaris Global provides executive advisory and Virtual Chief Compliance Officer (vCCO support) to organizations aligning systems and business processes with FDA, ISO 9001, ISO 27001, ISO 13485, and EU MDR requirements. We help leadership teams develop scalable, risk-based approaches to Computer System Validation (CSV), regulatory readiness, and audit preparation without disrupting business progress.

Our work spans digital systems, quality processes, and vendor oversight, guiding clients through the strategy, governance, and internal alignment needed to support compliant operations in regulated industries.

• Compliance and readiness strategy development
• Risk-based CSV planning for enterprise and cloud systems
• Governance design across IT, Quality, and Regulatory functions
• Assistance with implementation of QMS and ISMS applications and processes
• Partner and vendor validation oversight
• Audit preparation and documentation gap analysis
• Executive coaching on regulatory impact and prioritization

• Manage compliance programs 
• Conduct risk assessments
• Develop policies and procedures
• Ensure adherence to legal and regulatory requirements for organizations

These offerings are often embedded in ERP, QMS, and digital transformation programs, especially for growth-phase or globally expanding organizations preparing for inspections and market entry.

Felaris Global helps ensure compliance becomes a strategic advantage, not an operational burden.