Inspect the method before you engage ClinicOps.
Everything here runs in your browser; nothing you enter or import leaves it. One main application, a few focused utilities, and sanitised specimens of the delivery format.
Elsewhere in this market, a "gap analysis tool" is usually a lead form for a paid checklist or a sales call. These run the actual check — in your browser, free, before you talk to anyone.
Not sure where to start? Use the Regulatory Integrity Scanner. The utilities below are specialist checks for narrower questions.
The main application
Regulatory Integrity Scanner
Two modes, one discipline. Single change: anchor an approved source, declare the downstream records that should reflect it, compare deterministically, export the exception queue. Portfolio scan: import a CSV, XLSX or JSON export, map columns to regulatory objects (saveable mapping profiles), and review missing-field, duplicate, check-digit and conflicting-value findings in a filterable exception workbench with owners, review states and exports.
Interactive Integrity Specimen
Walk a synthetic register row by row: reference evidence, deterministic signal, human decision. See also the Class III transition map sample.
Focused utilities
Identifier Check
Screen Basic UDI-DI, UDI-DI and SRN structure, including common actor-role shapes. Structure only: it does not verify current status or compliance.
Regulatory Change Integrity Check
The deep single-change packet: reference provenance, downstream observations, evidence completeness, SHA-256 fingerprint and JSON re-import.
Change Surface Mapper
List the systems, records, documents and owners one change may touch, before deciding whether a review is needed.
Regulatory Change Impact Mapper
Pick a generic category of EU regulatory change, answer six portfolio questions, and get a deterministic impacted-surface checklist with an evidence-review queue. Sanitised prototype.
Technical File Consistency Check
Paste the same key fact — name, UDI-DI, intended purpose, shelf life, software version — as it appears in up to five document sources and get a deterministic, severity-banded divergence report. Sanitised prototype.
Readiness & economics
Two aids for scoping conversations: the Transition Readiness Score and the change-review cost calculator.
Pharmacovigilance utilities
For PV teams covering Denmark from a global hub, and for anyone renegotiating agreements under Commission Implementing Regulation (EU) 2025/1466. Each runs in your browser, cites its sources and carries a documented-tool assessment.
Danish Local-Literature Source Register
Fourteen Danish periodicals and regulator outputs with ISSN, cadence, audience and indexing status verified at source, plus a journal-list justification memo and weekly screening-log generator for GVP Module VI (VI.B.1.1.2).
SDEA / PV Agreement Clause Checker
Thirty-five cited rules — the Article 6(3)–(4) clause set in force from 12 February 2026, Article 13 audits, Directive timelines and GVP expectations. Keyword scan, manual review, gap report by severity, reconciliation-log template.
Danish DHPC Submission Checker
The Danish Medicines Agency's documented DHPC process as a 26-item checklist: submission pack, format, plain-Danish translation rules, multi-MAH coordination, evidence — with Nordic notes for Norway, Sweden and Finland.
From free structure to paid evidence work
When a free tool shows unresolved ownership, missing evidence or reconciliation work across systems, the paid formats take it from there: the Portfolio Integrity Scan and the flagship Regulatory Change Integrity Review.
Inspect the review formatScope a review