Glossary
Change control
The formal process that decides whether a change to a validated system is allowed, what testing it needs, and who approves it.
Validation proves a system correct at a moment in time. Change control is what keeps that proof meaningful afterward: every modification, from a patch to a workflow redesign, passes through an assessment of what it could break and what evidence is needed before it goes live.
Good change control is proportionate. A like-for-like server replacement does not deserve the same ceremony as a new calculation in a LIMS. Writing that proportionality into the procedure, rather than treating every change as maximal, is what separates workable systems from ones teams quietly route around.
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