Artifacts: Version-Controlled Work Products & Deliverables

Last Audited: 2026-08-14
Tier-2 Authoritative
In Plain Language

An artifact is any tangible, version-controlled work product created, modified, or consumed during the engineering process. This includes code, test scripts, architecture decision records, risk management files, and automated compliance logs. In regulated software, artifacts are not optional paperwork—they serve as the primary legal evidence that safety, security, and quality controls were actively followed.

Artifacts as Immutable Evidence

In deterministic and regulated engineering, an artifact is any version-controlled work product that records decisions, defines system specifications, contains executable code, or provides automated test proof. Artifacts serve as both the inputs and outputs of activities, creating an unbroken chain of custody across the software lifecycle.

1. Specification Artifacts

User Needs, Software Requirements Specifications (SRS), and interface contracts defining "what" the system must do.

2. Engineering Artifacts

Source code, Infrastructure as Code (IaC) templates, Dockerfiles, and Architecture Decision Records (ADRs).

3. Verification Artifacts

Automated unit and integration test reports, SAST/DAST security scans, and code review audit records.

4. Governance Artifacts

Design History Files (DHF), Traceability Matrices (RTM), Risk Management Plans (ISO 14971), and SBOMs.

Artifact Input / Output Traceability Flow

Every activity consumes upstream artifacts and produces downstream artifacts, ensuring complete audit traceability:

ActivityInput ArtifactsOutput ArtifactsCompliance Value
Requirements ElicitationUser Needs, Clinical WorkflowsSoftware Requirements Specification (SRS)ISO 13485 Cl. 7.3.3 (Design Input)
Threat ModelingArchitecture Diagram, Data Flow MapsSTRIDE Threat Model Report & MitigationsISO 27001 A.8.25 (Secure SDLC)
Automated VerificationCommitted Code, Test SpecsCI Test Execution Logs, Coverage ReportsIEC 62304 Cl. 5.5 (Software Testing)
Generate Artifact Traceability Checklist

Audit artifact input/output traceability for a medical device software release.

Review the following list of software artifacts for a Class II medical device: - User Needs Document - Software Requirements Specification (SRS) - Automated Unit & Integration Test Reports - Software Bill of Materials (SBOM) - Risk Traceability Matrix (ISO 14971) Generate an audit verification checklist confirming bidirectional traceability from User Needs down to Test Evidence as required by FDA 21 CFR §820.30.

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