Configuration Management and Design Transfer#

Document Control#

Document ID

DHF-009

Version

1.0

Date

2026-03-22

Author

pacs008 Engineering

Status

Released

ISO 13485 Clauses

7.3.8 (Design and Development Transfer), 4.2.3 (Control of Documents)

1. Version Control#

1.1 Repository#

  • System: Git

  • Hosting: GitHub

  • Repository: pacs008 (private)

  • Default branch: main

1.2 Branching Strategy#

  • main — Production-ready code. All CI checks must pass before merge.

  • feature/ — Feature development branches. Created from main, merged back via pull request.

  • fix/ — Bug fix branches. Created from main, merged back via pull request.

All branches must pass the full CI pipeline before merge. Direct pushes to main are prohibited.

2. Commit Policy#

2.1 Signed Commits#

All commits must be cryptographically signed using GPG or SSH keys. This provides:

  • Authentication: Verifies the identity of the committer

  • Integrity: Guarantees the commit has not been tampered with

  • Non-repudiation: Creates an auditable chain of authorship

Unsigned commits are rejected by repository policy.

2.2 Commit Message Format#

Commits follow conventional commit format:

<type>(<scope>): <description>

[optional body]

[optional footer]

Types: feat, fix, docs, style, refactor, perf, test, build, ci, chore

Examples:

feat(xml): add pacs.008.001.13 support with expiry datetime
fix(validation): correct IBAN checksum for edge case
test(gold-master): add v13 reference fixture

3. Pre-commit Hooks#

The .pre-commit-config.yaml file defines 13 hooks that run before every commit:

#

Hook

Purpose

1

trailing-whitespace

Removes trailing whitespace from all files

2

end-of-file-fixer

Ensures every file ends with a single newline

3

check-yaml

Validates YAML file syntax

4

check-json

Validates JSON file syntax

5

check-toml

Validates TOML file syntax

6

check-merge-conflict

Detects unresolved merge conflict markers

7

check-added-large-files

Rejects files larger than 500 KB

8

mixed-line-ending

Enforces LF line endings (--fix=lf)

9

detect-private-key

Prevents accidental commit of private keys

10

ruff (lint)

Code linting with auto-fix (--fix)

11

ruff-format

Consistent code formatting

12

black

Code style enforcement (line-length=79)

13

mypy

Static type checking (strict mode, pacs008/ only)

4. Configuration Items#

Item

Type

Location

Source code

Python

pacs008/ (43 modules in 14 packages)

Test suite

Python

tests/ (36 test files, 1,417 test cases)

Jinja2 templates

XML

pacs008/templates/pacs.008.001.XX/template.xml (13 files)

XSD schemas

XML Schema

pacs008/templates/pacs.008.001.XX/pacs.008.001.XX.xsd (13 files)

Reference XML

XML

pacs008/templates/pacs.008.001.XX/pacs.008.001.XX.xml (13 files)

Project metadata

TOML

pyproject.toml

CI pipeline

YAML

.github/workflows/ci.yml

Pre-commit config

YAML

.pre-commit-config.yaml

Dockerfile

Dockerfile

Dockerfile

Documentation

RST

docs/ (Sphinx source)

Changelog

Markdown

CHANGELOG.md

DHF documents

RST

docs/dhf/ (9 files, this document set)

5. Baseline Definition#

Baseline: v0.0.1 (2026-03-21)

This baseline represents the initial release of the pacs008 library with the following verified characteristics:

Characteristic

Value

pacs.008 versions supported

13 (001.01 through 001.13)

Test count

1,417

Branch coverage

100%

Bandit SAST findings

0

mypy strict errors

0

ruff/black violations

0

Pre-commit hooks

13 (all passing)

CI matrix configurations

14 (12 test + 1 lint + 1 security)

Python versions

3.9, 3.10, 3.11, 3.12

Operating systems

Linux (Ubuntu), macOS, Windows

Data source formats

5 (CSV, JSON, JSONL, SQLite, Parquet)

Risk mitigations

12 (all verified, all residual risk Low)

The baseline is tagged in Git as v0.0.1 and represents a complete, verified, and traceable release.

6. Release Process Checklist#

Before any release, the following steps must be completed:

#

Step

Verification

1

All CI pipeline jobs pass (test, lint, security, smoke)

GitHub Actions green status

2

Branch coverage >= 99%

--cov-fail-under=99 in pytest output

3

Bandit SAST reports zero findings

CI security job output

4

mypy strict reports zero errors

CI lint job output

5

All 13 gold master tests pass

test_gold_master.py output

6

All pre-commit hooks pass

pre-commit run --all-files

7

CHANGELOG.md updated with release notes

Manual review

8

Version number updated in pyproject.toml

Manual review

9

DHF documents updated if requirements, architecture, or risks changed

Manual review

10

Git tag created and signed

git tag -s vX.Y.Z

11

Package built and tested locally

poetry build && pip install dist/*.whl

12

Package published to PyPI

poetry publish

13

Docker image built and tested

docker build -t pacs008:vX.Y.Z .

14

Release notes published on GitHub

GitHub Releases page

7. Deployment Architecture#

The pacs008 library is distributed through three channels:

7.1 PyPI Package#

  • Build: poetry build produces source distribution and wheel

  • Publish: poetry publish uploads to PyPI

  • Install: pip install pacs008

  • Dependencies: Resolved from pyproject.toml at install time

7.2 Docker Container#

  • Base image: python:3.12-slim

  • Build: docker build -t pacs008:latest .

  • Port: 8000 (REST API via uvicorn)

  • User: appuser (non-root)

  • Health check: HTTP GET to /api/health every 30 seconds

  • Startup: python -m uvicorn pacs008.api.app:app --host 0.0.0.0 --port 8000

7.3 Source Installation#

  • Clone: git clone <repository>

  • Install: poetry install

  • Verify: poetry run pytest

  • Usage: Import pacs008 directly or run CLI/REST API

On this page
Show Source