coreason-scribe

The "Compliance Officer in a Box" | Unified GxP Documentation Engine

Executive Summary

coreason-scribe is the GxP documentation automation engine for the CoReason ecosystem. It addresses the "Validation Gap" where documentation inevitably drifts from code.

By treating Documentation as Code, coreason-scribe parses your agent's logic, uses AI to generate human-readable summaries (System Design Specifications), enforces Risk-Based Traceability (Requirements ↔ Tests), and facilitates a rigorous "Draft-Review-Sign" workflow. It ensures that no release is published without a cryptographically signed artifact proving it meets all requirements.

coreason-scribe can operate as a local CLI tool for developers or as a Compliance Microservice (FastAPI) integrated into CI/CD pipelines (e.g., coreason-publisher) and review platforms (coreason-foundry).

Core Philosophy: "Code is Truth. AI Drafts. Humans Ratify. Diffs Reveal Risk."

1. AI as the Drafter: Scans Python AST and generates plain-English business logic summaries.
2. Risk-Based Traceability: Enforces 100% test coverage for High Risk features.
3. Semantic Delta: Surfaces logical drift between versions, not just line-by-line diffs.
4. 21 CFR Part 11 Signatures: Requires cryptographic signatures for release certification.

Getting Started

Prerequisites

• Python 3.12+
• Poetry

Installation

poetry install

Basic Usage

Generate a draft SDS from your source code:

poetry run python -m coreason_scribe.main draft \
  --source ./src \
  --output ./build \
  --version "0.1.0"

Run a compliance check (CI/CD Gate):

poetry run python -m coreason_scribe.main check \
  --agent-yaml ./agent.yaml \
  --assay-report ./assay_report.json

For detailed instructions, see the Usage Guide.

Server Mode (Microservice)

Start the REST API server:

poetry run uvicorn coreason_scribe.server:app --port 8001
# OR
docker run -p 8001:8001 coreason-scribe:latest

Documentation

• Requirements
• Usage Guide
• Product Requirements Document

Development

This project follows a strict iterative, atomic, test-driven development protocol.

• Linting: poetry run pre-commit run --all-files
• Testing: poetry run pytest