Validation is creating an evidence trail to show that an action, method, or system leads to a consistent and reproducible result. Validation is the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process or components of a process can consistently deliver a quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process.
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Stage 3 Process Validation: Applying Continued Process Verification Expectations
This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and…

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