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
DefineBusiness Understanding
Scope the problem, screen for regulatory applicability, and commit to a documented business case before any design work begins.
4artifacts
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PrepareData Understanding
Source, assess, and document the data this system will actually run on — quality, bias screening, and lineage, before a single feature is engineered.
2artifacts
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DesignSolution Architecture
Turn the approved business case into an architecture — schematics, tech stack, API contracts, and the human-oversight design that can't be retrofitted later.
2artifacts
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DevelopModel Development
Build, train, and document the model — with a full record of what was tried, what was kept, and why.
4artifacts
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ValidateModel Validation
Independently prove the system works — functional, security, AI/model, and formal GxP qualification testing, all traced back to source requirements.
7artifacts
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DeployDeployment
Go live — cutover, readiness confirmation, and hypercare, approved as one plan before any of it starts.
1artifacts
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Hypercare & Transition to MLOps
The project team stays in product mode through hypercare, sets up the monitoring process and documentation, then formally hands off to steady-state MLOps. This is where the project methodology's scope ends — ongoing monitoring, periodic review, and change control continue indefinitely under MLOps, outside this framework.
3artifacts
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Cross-CuttingNot phase-bound
Governance, risk, and compliance documents that span the whole lifecycle rather than belonging to a single phase — including the recurring MLOps-owned checkpoints (Periodic Review, Change Control) that continue after the project team's handoff, and Retirement, run as its own dedicated track.
23artifacts
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