ChiefTrace Whitepaper

How TSE + CAL deliver audit-ready compliance, real-time traceability, and explainable risk scoring for regulated industries.

Executive Summary

ChiefTrace combines an append-only change ledger (CAL) with a graph-based impact engine (TSE) to automate traceability, generate sealed audit evidence, and quantify risk with transparent factors. The result: fewer surprises, faster approvals, and confident releases — from MedTech to DoD/FAA.

Immutable change history: cryptographic hash chaining for tamper-evident records
End-to-end traceability: requirements ⇄ design ⇄ tests ⇄ SOPs ⇄ CAPAs
Explainable risk: CIS/SID with factor breakdown (B, C, P, R, A, D)
Audit-ready exports: signed bundles aligned to FDA 21 CFR Part 11 & ISO 13485
Integration-first: CSV, webhooks, Jira/Git/DOORS-ready approach

What’s Inside

Architecture

Core services, data model, and integration pathways for TSE + CAL.

CAL: hash-chain structure, record schema
TSE: graph model, link semantics, traversal
APIs: ingest/export patterns

Compliance Mapping

How audit trails, signatures, and traceability align to FDA/ISO/IEC/HIPAA.

Part 11 expectations
ISO 13485 & 14971 hooks
62304 lifecycle trace

Risk & Integrity

Explainable scoring and health metrics with configurable weights.

CIS formula (B×C×P×R×A×D)
SID health trends
Governance controls

Operational Playbook

Deployment options, roles and responsibilities, and validation artifacts.

Roles & RACI
Validation package
Security baseline

Download the Whitepaper

Get the full technical brief (PDF). We’ll also send you a link by email.

PDF • ~18–25 pages • diagrams & evidence examples
No fluff, just engineering detail

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