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. We assess, stabilize, and govern IT operations for organizations where operational and compliance requirements are inseparable.

Underperforming IT operations create risk through system downtime, compliance gaps, and vendor dependency that the organization does not fully understand. We conduct structured operational assessments that identify the real risks, separate from the perceived ones, and build remediation plans with clear priorities, owners, and timelines.

What you get: IT operational maturity assessment, infrastructure performance and capacity analysis, service delivery evaluation, incident and problem management review, vendor and support contract assessment, remediation roadmap with prioritized actions

Regulated environments require documented IT processes, formal change control, and governance frameworks that produce audit-ready evidence. These are not administrative overhead - they are regulatory requirements under FDA 21 CFR Part 11 and ISO 13485. We design and implement IT governance structures aligned to the regulatory obligations of your specific environment, not generic ITIL templates applied without context.

What you get: IT governance framework design, change management and release management processes, configuration management and asset tracking, IT risk management structure, service level management and KPI development, audit preparation and documentation

Legacy infrastructure in regulated environments creates a specific set of problems: performance bottlenecks that affect manufacturing systems, security risks that violate compliance requirements, and technical debt that makes validation of any system change more expensive than it needs to be. We assess infrastructure against both operational and regulatory requirements and develop modernization strategies that improve capability without creating new compliance risk.

What you get: Infrastructure architecture assessment, cloud readiness evaluation and migration strategy, network architecture optimization, data center consolidation planning, backup and recovery design, capacity planning and performance optimization

Multi-site, multi-country operations require coordinated IT service delivery across time zones, languages, regulatory jurisdictions, and organizational structures that do not always align. We have run global IT operations across the US, UK, Germany, Scandinavia, India, China, and the Caribbean, and we design service delivery models that balance central governance with local operational reality.

What you get: Global service delivery model design, follow-the-sun support strategy, regional IT organization design, service desk and ITSM implementation, vendor consolidation and global contract management, cross-border data management and compliance alignment

Regulatory requirements for business continuity are not optional in FDA and EU MDR environments. Inspectors expect documented recovery objectives, tested recovery procedures, and evidence that the organization has evaluated the impact of system failure on product quality and patient safety. We design and implement BC/DR programs that satisfy compliance requirements and actually protect business operations when tested.

What you get: Business impact analysis and recovery objective definition, disaster recovery strategy and architecture, backup and recovery testing protocols, business continuity plan development, crisis management and communication planning, regulatory compliance validation for FDA and ISO requirements

• 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.