Publications

QMS‑integrated trace‑fusion format with a monotone logit model for auditable QA/QMS risk monitoring.

• QMS-integrated quantitative risk transfer framework with monotone constraints for audit-friendly risk monitoring.
• Focuses on traceable inputs, clear scope, and decision-support outputs (probability-like score; not a calibrated clinical probability).
• Published as a minimal preprint artifact; supplementary packages can be released as later Zenodo versions.

A quantitative, auditable risk-control framework that turns drift monitoring into regulator‑ready triggers.

• Outcome-focused drift governance: define triggers that can be defended under audit.
• Separates early warning from execution decision to reduce panic-driven changes.
• Designed to integrate with QMS / change control narratives (implementation remains shared privately).

A maturity ladder mapped to GMP/quality system concepts to make readiness measurable and comparable.

• Makes readiness measurable: a common language for prioritization and planning.
• Turns gaps into action-oriented work packages and review checkpoints.
• Provides an evidence-first narrative for stakeholders (implementation details shared privately).

Stakeholder-ready overview deck for industry use cases: compares RRL‑P and RRL‑QMS; no enabling implementation details.

• Stakeholder-ready overview deck: high-level comparison of RRL‑P and RRL‑QMS.
• Clarifies purpose, interpretation, and boundaries without exposing implementation mechanics.
• Useful as a kickoff artifact before a readiness assessment and stakeholder alignment.

Manuscript (PDF) with method and references.

• Defines a staged nine‑level QMS readiness ladder mapped to regulatory expectations.
• Connects readiness level to approval probability via a calibrated logistic regression model (method described).
• Includes a references section anchored on primary regulatory and standards sources.

Comparative table appendix (PDF).

• Outcome-focused comparison table for stakeholder alignment (not implementation guidance).
• Positions RRL‑QMS relative to common maturity frameworks, with clear scope notes.
• Detailed mappings and operationalization are shared privately.