We built this for a client spending
weeks on manual compliance reviews
A regulated-industry client needed to review controlled documents against FDA 21 CFR Part 11 — a process that took their team weeks of manual cross-referencing. We built an AI-powered regulatory gap analysis system that does it in minutes, with evidence-backed findings and specific remediation guidance.
Try it yourself with sample policy sets below. This is the same architecture we deploy for client engagements.
Acme Pharma
MatureEstablished pharmaceutical company with a comprehensive but aging policy framework. Good coverage in most areas with specific gaps in open system controls and electronic signature linking.
Documents (3)
GlobalMfg
MixedGlobal manufacturing company with strong validation and change control practices but significant gaps in electronic signature controls and inconsistent terminology.
Documents (2)
Startup Bio
Early StageEarly-stage biotech with a single combined policy document. Basic data integrity principles but significant gaps across most Part 11 requirements. Demonstrates high volume of actionable findings.
Documents (1)
What we learned building this
Enterprise platforms like Microsoft Copilot and Box AI are excellent at search and summarization. But regulatory gap analysis requires structured assessment of controlled documents — checking every requirement, citing specific evidence, and flagging what's missing. That's a custom build.
Structured gap analysis, not Q&A
Reviews every regulatory requirement systematically against your controlled documents — no questions to ask, no prompts to write.
Evidence-backed findings
Every assessment cites specific policy language and regulatory text. No unsupported claims.
Cross-document reasoning
Detects contradictions, broken references, and coverage splits across your controlled document set.
Actionable remediation
Each gap comes with specific guidance on what your policy should address — not generic advice.
Sample policies are synthetic controlled documents. This is the production architecture — your regulatory framework, your documents.