Organizational Chart and Job Descriptions
Elena opened the first binder. Thus began her journey through the hierarchy of QA documents—the hierarchy that keeps patients safe.
A strategic document outlining how and when validation activities (process, cleaning, equipment) will occur. 2. Standard Operating Procedures (SOPs)
These define what "good" looks like.
The goal is not volume—it is completeness . A missing cleaning log or an unsigned change control form is a common FDA 483 observation.
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