Harness Evidence Worksheet for AI Supplier Assessment

A fillable worksheet for locating evidence about the harness component of an AI validation boundary during supplier assessment in regulated life sciences.

Existing supplier questionnaires and management-system standards cover model provenance, vendor governance, change control, and security attestation. They say comparatively little about the engineered layer around the model — retrieval and context assembly, orchestration and tool routing, model invocation, output validation, telemetry, and failure response — where much of a probabilistic system's behavior is determined.

The worksheet has five parts. The sponsor first declares the context of use, the model and how it is supplied, the configuration under assessment, and the human-in-the-loop arrangement. A standalone question set is then issued to the vendor. Responses are recorded in a grid of harness elements, each assigned an ownership state: sponsor, vendor, split, unassigned, or not applicable.

The worksheet locates evidence and records ownership. It does not assess sufficiency, verify vendor claims, or constitute validation evidence. It covers the harness in depth and assumes the other three boundary components are declared, not assessed.

Intended users: procurement, IT/data science, process owners, validation and quality.

Two documents: Worksheet and Supplier Worksheet (the worksheet, and a standalone question set to issue to the vendor)