Global IT Operations and Governance

Regulated manufacturing and medical device organizations require IT operations that meet a higher standard than uptime and response time. Change control, audit trails, access management, disaster recovery, and service delivery governance are all areas an FDA inspector or EU MDR auditor will examine. Felaris assesses, stabilizes, and governs IT operations for organizations where operational and compliance requirements are inseparable, across the US, Caribbean, and Europe.

Underperforming IT operations create risk through system downtime, compliance gaps, and vendor dependency the organization does not fully understand. Felaris conducts structured assessments covering infrastructure performance, service delivery, incident and problem management, backup and disaster recovery, change control, security and access control, and compliance posture. The output is a remediation plan with clear priorities, owners, and timelines.

When IT operations management practices are ad-hoc and reactive, risk accumulates. Felaris establishes IT operations maturity: service delivery framework and SLA definition, change control and configuration management, incident and problem management, disaster recovery planning, governance structure, service delivery metrics, and vendor oversight aligned to regulatory requirements.

Infrastructure and cloud platform decisions impact scale, cost, and compliance. Felaris evaluates on-premise versus cloud infrastructure, assesses platform options (AWS, Azure, GCP), plans migration and consolidation, and develops disaster recovery and business continuity plans with defined RTO and RPO for all systems.

User access control, audit trails, and vendor performance oversight are regulatory requirements in FDA and EU MDR environments. Felaris implements identity and access management, multi-factor authentication, privileged access management, security monitoring, vendor evaluation frameworks, contract governance, and cost optimization.

IT operational maturity directly affects AI readiness. Endpoint management, identity governance, and data infrastructure are prerequisites for any AI deployment. See AI Business Foundation Services.

• FDA Requirements: 21 CFR Part 11 (Electronic Records and Signatures), 21 CFR Part 820 (Quality System Regulation), FDA guidance on computer software assurance
• ISO Standards: ISO 13485 (Quality Management System for Medical Devices), ISO 22301 (Business Continuity Management), ISO 9001 (Quality Management)
• Data Protection: GDPR, data residency and sovereignty requirements across US and European operations
• Industry Frameworks: ITIL service management, COBIT governance framework

Medical device manufacturing, pharmaceutical and life sciences, regulated manufacturing, warehouse and distribution, industrial manufacturing, growth-stage companies

• IT operations struggling with recurring downtime, performance issues, or compliance audit findings
• Regulated environment requiring documented IT governance, change control, or ITIL-based processes
• Legacy infrastructure creating bottlenecks, validation overhead, or unsustainable technical debt
• Multi-site or global operations lacking coordinated service delivery and consistent governance
• Business continuity or disaster recovery program failing to meet FDA or ISO 22301 requirements
• Post-acquisition environment requiring IT infrastructure assessment and operational stabilization

For cybersecurity program development, vCISO services, and security risk management in regulated environments, see our Cybersecurity for Regulated Industries page.