HELIOS
Genomics pipeline audit and validation framework: signed audit trails, machine-readable evidence, compliance-oriented checks, and exports (JSON, PDF, RO-Crate).
Apache-2.0 core · commercial support & dashboard hosting
What HELIOS is
HELIOS is a technical framework for capturing how pipelines actually ran: inputs, containers, references, and checks—so labs can build reproducible, reviewable evidence. It integrates with common workflow engines and is designed for teams that must show traceability and validation discipline without pretending a tool replaces accreditation or legal sign-off.
How we offer it
Core framework: open source under Apache License 2.0. You can adopt the CLI and libraries in your own environment, inspect the code, and extend checks—same spirit as our other Apache-2.0 tooling.
Commercial: Synaptic Four offers paid support (onboarding, prioritised fixes, integration help) and optional hosted dashboard operations for organisations that want a managed UI and service-level expectations. Details are agreed per engagement; the public repository remains the source of truth for the OSS core.
Price band (orientation)
The OSS core (CLI, library, Apache-2.0) is free and stays free.
| Service | Guide |
|---|---|
| Support package (onboarding + 12 months prioritised support) | from €3,600/year |
| Dashboard hosting (managed, incl. updates) | from €350/month |
| Integration support (project-based) | on request after an initial call |
All figures net; VAT extra. Exact terms after a needs discussion.
Who it fits
- Clinical genomics and high-throughput labs documenting validation and software controls (e.g. themes aligned with ISO 15189:2022—still your QMS and your accreditation path).
- Teams that already use GA4GH-oriented stacks and want audit exports and reference integrity checks that interoperate with broader ecosystem expectations.
- Programmes that need technical documentation and data-governance artefacts in EU AI Act conversations (Articles 10/11 themes)—engineering evidence, not a legal verdict.
Standards alignment (orientation)
HELIOS is built to produce evidence that maps to common regulatory and interoperability narratives. It does not certify your lab or replace qualified sign-off.
- ISO 15189:2022 — themes such as software validation traceability, controlled changes, and reportability of pipeline outputs (implementation remains your responsibility).
- GA4GH — reference integrity, transcript-style evidence, Crypt4GH-oriented handling where configured; alignment with interoperable genomics practice.
- EU AI Act — support for technical documentation and data-lineage style exports where your components fall in scope (legal classification stays with you).
What HELIOS is not
- Not a certification, accreditation, or regulatory approval by itself.
- Not a substitute for your quality manager, notified body, or counsel when those roles are required.
- Not a promise that any specific checklist item is “done”—it produces structured evidence you still must interpret in your QMS.
Install the open-source package from PyPI
pip install helios-audit Package name on PyPI is helios-audit. Version and API surface evolve with the repository README and docs.