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In a GxP environment, an audit refers to a systematic and independent on-site examination conducted to ensure that all processes, systems, and procedures comply with applicable regulations and quality standards. Audits aim to guarantee the integrity and quality of products by identifying weaknesses and risks and assessing the effectiveness of quality control measures. Audits can be performed by various entities, both internally and externally, such as by customers. Distinct in terminology, yet with the same underlying purpose, is an inspection, which may only be conducted by the relevant regulatory authorities.

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