# Executive Summary for Sponsors

## What this system does for you

This system exists to give sponsors **confidence**.

Confidence that:

- the software you are relying on does what it claims,
- requirements are explicit and testable,
- changes are controlled and reviewable,
- and evidence can be produced when needed—without delay or reconstruction.

It is designed specifically to support **regulated clinical and research workflows**, including FDA 21 CFR Part 11–adjacent use cases, without imposing heavyweight operational burden on study teams.

## Why it matters to sponsors

Sponsors are accountable for:

- data integrity,
- system validation,
- and regulatory submissions.

This framework provides:

- a clear chain from intent → requirement → implementation → verification,
- documented rationale for design decisions and accepted risks,
- and traceable evidence suitable for UAT, validation packages, and audits.

You are not asked to trust undocumented engineering judgment.  
You are given **structured, inspectable evidence**.

## Comparison to common approaches

### Vendor validation binders / static documentation

#### Similarities

- Formal, reviewable artifacts
- Supports validation and traceability expectations

#### Differences

- Evidence is continuously maintained, not assembled after the fact
- Artifacts remain consistent with the deployed system
- Change impact is surfaced automatically

### Traditional ALM tools (e.g., Jama, DOORS)

#### Similarities

- Formal requirements
- Traceability and change control

#### Differences

- Lower friction for development teams
- Stronger semantic guarantees
- Validation evidence is intrinsic to development

## Bottom line for sponsors

This system reduces sponsor risk by:

- simplifying validation,
- aligning engineering rigor with regulatory expectations,
- and ensuring deployed software matches approved intent.
