Adopt
CI/CD pipeline. Managed infrastructure — no server to validate as a computerised system under 21 CFR Part 11. Every workflow run, step, and artefact produces a native audit trail within GitHub, closing the traceability loop from issue to deployment without additional tooling.
Chosen over Jenkins (infrastructure overhead, requires validation as a computerised system) and Azure DevOps Pipelines (GitHub Actions achieves the same outcome with less context switching). See DEC-002.