One of the key aims of an internal auditor is to ensure that any observations or recommendations that are written into the final report are agreed to by the parties that were audited.

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Looking to improve your compliance profile? This is an obvious point, but sometimes the most obvious points are the ones that are most overlooked. Make sure that you understand and refer to the details of the relevant section of the regulations. Most regulations are there because they make sense.

For example, with respect to CAPA management, the FDA QSRs spell out the expectations, and when you think about it, they are very logical with respect to providing a route to achieving the intended outcome (effective corrective or preventive action).

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