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.
Frequently asked questions
What does Compliance Copilot do?+
It ingests controlled documents — policies and procedures — and produces a structured gap analysis against a regulatory framework, with the supporting evidence and remediation guidance attached to each finding. It turns weeks of manual cross-referencing into a reviewable report a human signs off on.
Can AI really be trusted for regulatory and compliance review?+
It's built as decision support with a human in the loop, not an autonomous approver. Every finding cites the specific document passage behind it, interactions are logged for audit, and a reviewer keeps sign-off authority. The value is removing the slow, error-prone hunting while keeping accountability with a person.
Does it work with our framework and our documents?+
Yes. The demo runs on sample policies, but the same architecture adapts to your specific regulatory framework and your controlled-document set. Discovery maps your requirements and documents before any build.
How is this different from keyword search over our policies?+
Keyword search finds documents that mention a term; it doesn't tell you whether a requirement is met or where the gap is. Compliance Copilot reasons across the document set, identifies gaps and conflicts, and shows the evidence for each conclusion — answering 'are we compliant and where aren't we,' not just 'which files mention this.'
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.