What is validation and Qualification,capa,IR

Question

Accepted Answer

Validation and qualification are processes used in manufacturing to ensure that equipment, processes, and systems meet predefined standards and requirements.

Validation is the process of establishing documented evidence that a system or process consistently produces results that meet predetermined specifications.
Qualification is the process of demonstrating that an equipment or system is properly installed, operates correctly, and produces the expected results.
CAPA stands for Corrective and Preventive Actions, which are measures taken to identify, investigate, and address the root causes of non-conformities or deviations.
IR refers to Investigation Report, which is a document that outlines the findings and conclusions of an investigation into a specific issue or incident.
Validation and qualification are essential in industries such as pharmaceuticals, where strict regulatory requirements must be met to ensure product quality and patient safety.

Accepted Answer

Qualification is related to instruments and equipment. Meaning, instruments and equipment tend to qualify. Validation is related to processes. Meaning, the processes tends to validate.

Accepted Answer

Validation is consistency of equipment or product specification results and methods

What is validation and Qualification,capa,IR

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