Rationale

Reasoning behind decisions

Rationale is defined as a set of reasons or a logical basis for a course of action or a particular belief. Any time there is an evaluation or risk assessment, rationale (or justification) should be included to support the pathforward. Rationale is required when determining worst-case product, equipment grouping, and sampling plans. Changes to the validated cleaning process must also have the rationale included in the writeup (FDA Process Validation: General Principles & Practices).