Change control is the formal process for evaluating, approving, and documenting modifications to validated GxP systems to protect product quality and compliance status.
Definition
Change control in a GxP environment is the formal process for evaluating, approving, and documenting any modification to a validated system, process, or facility. Every change must be assessed for its impact on product quality, regulatory compliance, and validated state before it's implemented. In MES environments, even a minor configuration change , a user permission update, a workflow tweak , can require a formal change control record and potentially revalidation.
What this means when you're hiring
Change control discipline is what separates engineers who've worked in genuinely regulated environments from those who haven't. I ask candidates to describe a change they managed through formal change control. The quality of that answer tells me whether they understand the full process , impact assessment, QA approval, implementation verification, and validation impact assessment.
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