A C D E F G H I L P Q V
Pre Pro

Predicate Rules

Predicate Rules are the FDA’s actual requirements, such as 21 CFR 211 for pharmaceuticals or Part 820 (the QMSR since 2026) for medical devices. They determine which records must be kept and which signatures must be applied. 21 CFR Part…
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Process

A process is a set of interrelated or interacting activities which transform inputs into outputs.…
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Process Validation

Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes (EU GMP Annex 15). Initial validation establishes this capability; the…
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