Prototype — this is a working draft, shared for feedback and discussion. Not a finished, certified, or officially adopted framework. Scope — not intended for use as, or in the development of, a regulated medical device.
Home / Key Artifacts Matrix / Define
Phase 1

Define · Business Understanding

Scope the problem, screen for regulatory applicability, and commit to a documented business case before any design work begins.

4Artifacts
2Word
2Excel
Business Case & Project Charter
Word
9 sections incl. regulatory screening; high-level cost summary table
↓ Download Template
Solution Cost Estimate
Excel
66 line items across 14 categories; live formulas; Benefits Quantification + automatic ROI/payback calculator
↓ Download Template
Compliance Analysis
Word
Product-level living document; GxP×EU AI Act×data-sensitivity matrix
↓ Download Template
Requirements & User Story Backlog
Excel
Requirement → user story → acceptance criteria chain; MoSCoW priority
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