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Requirement lifecycle

The states a requirement moves through: proposed, analyzed, approved (baselined), allocated, implemented, verified, validated, released; with the side states rejected, deferred, change-requested, superseded and retired. The requirements analyst moves it to analyzed. The business owner (with the PHI owner for PHI scope, and the clinical safety lead for safety-related items) moves it to approved. The architect moves it to allocated and the engineering lead to implemented. A verification lead independent of the implementer moves it to verified, and the business owner with a prescriber representative to validated. The change authority moves it to released, superseded and retired. Nothing is allocated before it is approved.

Nov 5, 2026

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Interim definition. BLORP takes this term over when the global ontology lifts from Phase-0.

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Requirement

A statement of what the system must do, or the constraint it must respect, in the target state. It is written with one "shall", one subject (the system or a role) and one behavior, and carries an id, a type, a level, an owner role, a scope, a rationale, a source, a verification method with acceptance criteria, a priority, a phase and a lifecycle status.

Requirement attribute

A named field every requirement carries: id, title, statement, type, level, owner, scope, rationale, source, priority, phase, status, verification, validation, risk, medical flags, trace, and change history and baseline. Together the attributes are the requirement ontology of the Analysis Document Standard.

Requirement type

The kind of a requirement. One of: business, stakeholder, functional, quality, service-level, security, regulatory, constraint, architecture, interface, data, operation or risk-control.

Requirement level

Where a requirement sits in the decomposition. One of: business, stakeholder, system or software.

Owner role (requirement owner)

The requirement owner is a role taken from the role register, never a person. Every requirement has an owner role, such as the business owner, the PHI owner or the platform owner. A person's name appears only in the role register, as the current holder of the role.

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