AI Regulatory Compliance Document Processing Agent

How Cassidy automates regulatory compliance using AI

Step 1: Ingest regulatory documents

The Workflow triggers when new regulations, standards, or guidance documents are added—whether from FDA, ISO, EU MDR, or internal uploads. Cassidy normalizes the content and tags it with jurisdiction, applicability, and version metadata.

Step 2: Extract and structure obligations

Cassidy's Knowledge Base and AI Agents parse the regulatory text to identify specific obligations, conditions, timelines, and citations. Each requirement is added to a centralized obligation register with owner assignments and due dates.

Step 3: Map to controls and SOPs

The Workflow matches extracted obligations against your existing control library and SOPs using semantic similarity. Cassidy flags gaps where no control exists and surfaces conflicts or overlaps requiring SME review.

Step 4: Generate gap analysis and remediation tasks

Cassidy produces a prioritized gap report with risk scoring and automatically creates change control tasks in your connected QMS or project management system, assigning owners and deadlines.

Step 5: Draft SOP updates

For identified gaps, Cassidy generates redlined SOP language aligned to specific regulatory clauses—ready for SME review, approval workflows, and version-controlled document management.

Step 6: Harvest and link evidence

Cassidy integrates with your ERP, MES, LIMS, and QMS to pull timestamped evidence artifacts. Each piece of evidence is linked to specific controls and time periods, maintaining ALCOA+ data integrity.

Step 7: Compile audit-ready binders

On demand or on schedule, Cassidy assembles complete audit packages—traceability matrices, control narratives, validation documentation, and linked evidence—with full provenance and approval history.