Work queue · top of the queue
All priority items →| Reg | Citation | Snippet | Verdict | Pri. | Conf. |
|---|
Strengths · top of the QMS
All strengths →| Reg | Citation | What's covered | SOPs | Conf. |
|---|
Regulators · coverage spread
All regulators →—
—
Top risks All priority items →
Enforcement headline FDA · US
Top strengths All strengths →
Regulatory intelligence
Cross-Jurisdiction Readiness Take this QMS to a new market
Device Profile & Precedent Classification · De Novo authorizations
By topic Top 8 of 16
By owner QMS roles
See every regulatory finding, in detail
Every clause scored, with rationale, cited QMS documents, recommended remediation, and FDA enforcement context.
High-priority gaps, in order
Every partial, gap, and missing flagged as high priority, sorted so the most exposing items surface first.
Reference integrity of the QMS
Every internal cross-reference in the uploaded documents, traced and checked that it resolves, surfacing references to a missing document or section, duplicate document IDs, and documents nothing else references. Set arithmetic on the files you provided; regulatory citations (21 CFR, ISO, IEC, MDR) are never counted as a broken reference.
python3 -m src.engine.doc_control against the same dump.
Every regulation & standard, in one place
The complete knowledge base the validator scores against: all five MDSAP jurisdictions (FDA 21 CFR, Health Canada CMDR, Japan PMD Act / MO‑169 / PMDA, Australia TGA, Brazil ANVISA), plus EU MDR/IVDR and the licensed ISO/IEC consensus standards. Open any instrument to read its clauses.
Validation runs
Every validation this tenant has run, newest first. Open one to load its gap report, or start a new validation to score the current QMS.
The whole quality system, organized
Every document uploaded for this tenant, classified on intake and grouped by type — SOPs, work instructions, the quality manual, forms, plans and reference standards. Open any document to read it.
Where the QMS reads strong
Compliant verdicts, ranked by confidence and the breadth of SOPs cited as supporting evidence.
Findings grouped by source SOP
Each SOP rolled up with the regulatory clauses it touches: strengths first, then high / medium / low severity findings.
Findings grouped by accountable role
Each QMS role rolled up with the regulatory clauses it owns: strengths first, then findings by severity.
Every regulatory clause, scored
Each verdict with rationale, cited SOPs, recommended remediation, and FDA enforcement context. Filter by status or jurisdiction.
These clauses were correctly identified by the engine as not imposing direct manufacturer QMS obligations. They are non-normative regulatory text (recitals, definitions, scoping provisions, routing rules, or obligations addressed to the European Commission, Member States, or competent authorities) rather than to medical-device manufacturers.
They are intentionally excluded from the readiness score so the engine neither penalises nor credits the QMS for clauses no manufacturer can act on. Click any row to see the verbatim text and the engine's reasoning.
