Regulatory gap analysis for controlled documents
A regulated-industry client was spending weeks manually cross-referencing controlled documents against FDA requirements. We built a system that turns unstructured policies into a structured regulatory gap analysis — with evidence and remediation guidance for every finding.
Why the client needed more than enterprise search
Repeatable review
The same checklist, the same assessment criteria, every time. Eliminates reviewer-to-reviewer variability and ensures complete coverage.
Evidence-backed findings
Every assessment cites specific policy language and regulatory text. Findings are defensible because the evidence trail is explicit.
Faster throughput
What takes a team days or weeks of manual review runs in minutes. Human reviewers focus on judgment calls, not document hunting.
Auditable trail
The structured output shows exactly what was checked, what evidence was found, and how each assessment was reached. Ready for audit review.
The system we built
Load requirements checklist
The system loads a structured checklist of 37 discrete requirements from FDA 21 CFR Part 11, organized by category (audit trails, access controls, electronic signatures, etc.).
Retrieve policy evidence
For each requirement, semantic search finds the most relevant sections from your policy documents. Related requirements are batched together for efficiency.
Assess coverage
An LLM evaluates whether the retrieved policy language adequately addresses each requirement. Every assessment must cite specific evidence — no unsupported claims.
Cross-document analysis
A second pass analyzes findings across the full document set, identifying contradictions between policies, references to documents not in the set, and requirements whose coverage is split across multiple documents.
Structured report
Results are delivered as a structured dashboard — not a chat response. Each finding includes the regulatory requirement, policy evidence, assessment rationale, and specific remediation guidance.
What we learned
The client had already evaluated Microsoft 365 Copilot and Box AI. Those tools are strong at finding and summarizing documents — but they couldn't replicate the structured gap analysis their compliance team needed: check every regulatory requirement against their controlled documents, cite specific evidence, flag what's missing.
This is a pattern we see often. The question isn't whether enterprise AI platforms are capable — it's whether your specific workflow needs a custom build on top of them, or alongside them.
We help clients figure that out — and when a custom build is the answer, we build it.
Your framework, your documents
Try the demo with sample policies, or talk to us about building regulatory gap analysis for your framework and controlled documents.
Same architecture, adapted to your specific requirements and workflow.