AI BUSINESS FOUNDATION SERVICES

AI programs fail when the data is ungoverned, the processes are undocumented, and the organization has no structure to sustain AI in production. Felaris builds the data management, process optimization, and governance foundation AI requires, or repairs it when an AI investment has already stalled. Twenty-five years of ERP implementations, data migrations, and compliance remediation in regulated industries. The data problems that kill AI programs are the same data problems that kill ERP programs.

Master data management assessment and implementation, data quality measurement and profiling, data lineage and traceability (required for AI auditability in regulated environments), data ownership and stewardship models, data architecture review for AI/ML workloads, and metadata management. Felaris connects AI data governance to existing FDA 21 CFR Part 11, EU MDR, and SOX ITGC compliance obligations.

AI applied to an undocumented, unmeasured process produces unreliable results that cannot be validated in a regulated environment. Felaris maps processes as they actually operate, measures cycle time, error rate, and decision points, standardizes across sites and business units, and identifies AI-suitable candidates: high volume, rule-based decisions, sufficient data, measurable outcomes.

Five-dimension evaluation: data (quality, governance, architecture), process (documentation, measurement, standardization), technology (infrastructure, integration, scalability), people (skills, roles, change readiness), and governance (policies, risk, oversight). Gap analysis, AI use case prioritization, and remediation roadmap.

Same assessment discipline Felaris applies to stalled ERP programs. Root cause analysis across data quality, process misalignment, governance gaps, vendor misfit, and organizational resistance. Recovery roadmap with prioritized remediation and governance to prevent recurrence.

FDA 21 CFR Part 11 data integrity, EU AI Act risk classification, ISO 13485 process documentation, SOX ITGC controls extended to AI-generated outputs, GAMP 5 Category 5 validation for AI/ML in GxP, and NIST AI RMF mapped to existing NIST CSF controls.

Organizations that need executive-level AI ownership alongside foundation work can engage a fractional CAIO to lead the AI agenda at the leadership table. The data governance and process documentation disciplines here are the same disciplines Felaris applies in ERP strategy and implementation.

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

Organizations with $50M to $500M in revenue in regulated industries: medical device, pharmaceutical, CDMO, manufacturing, and distribution. US, Caribbean, or European operations. Companies where AI is on the board agenda and no one at the leadership table owns the answer.