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.