Regulatory mapping · The requirement translation · Element
The evidence requirement
What must exist to demonstrate the requirement was met.
The part
What it is
For regulatory purposes, something done without evidence is close to something not done.
Deciding what the evidence is at translation time is what allows it to be produced automatically rather than assembled before an audit.
The smallest level
The attributes it carries
Each attribute is one of the framework’s shared types. What a date is, and how it is written, is defined once for the whole model — the note here says what it means in this particular place.
The other elements in the requirement translation
The requirements
What must actually be done, in operational language.
LearnThe owners
Who is accountable for each requirement being met.
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