Medical Devices: Software Build Pipeline Toolchain (ALM/CI/CD) Supporting Design Controls
What we succeed?
As a result of the partnership we established with Validfor, our testing, approvals, documentation, repository in one platform and standardized workflows and centralized validation knowledge
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The Problem
Unvalidated CI/CD Toolchain Undermining Traceability and Integrity of Device Software Outputs
An organization uses CI/CD pipelines and automated test runners to build and test device software — but without validated toolchain integrity, the quality of tool outputs cannot be assured. Medium risk arises from the direct influence these tools have on product software quality and the criticality of artifact traceability under design controls.
Tool outputs influencing product software quality without validated integrity controls
No verified build reproducibility or test execution consistency across pipeline runs
Pipeline script changes uncontrolled — no change control or review process in place
Artifact traceability gaps preventing complete design control documentation
The Strategy
Toolchain Validation Covering Output Integrity, Traceability, and Pipeline Change Control
The validation scope covered toolchain integrity, traceability, access control, audit trails where applicable, and change control of pipeline scripts — with testing focused on reproducibility and attributability of tool outputs to ensure the CI/CD toolchain reliably supports design control requirements.
Validate tool outputs: build reproducibility, test execution integrity, and artifact traceability
Access control and configuration management validation for pipeline definitions
Change control process established for all pipeline script modifications
An indispensable tool for managing the software validation life cycle. Comprehensive and structured, ensuring compliance throughout every phase.
Principal Validation Consultant
30+ Years Experience
The Solution
Validated Toolchain Delivering Reproducible, Attributable Outputs Under Design Controls
Tool outputs are reproducible and attributable across all pipeline runs. Changes to pipeline definitions are controlled and reviewed before deployment — ensuring the CI/CD toolchain operates as a trusted, validated component of the device software development process.
Tool outputs reproducible and attributable; consistent across all pipeline executions
Changes to pipeline scripts controlled via change control and subject to review before deployment
Artifact traceability confirmed end-to-end, supporting design control documentation requirements
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