During an audit of a manufacturing facility, what is the most appropriate action for a regulatory affairs professional if an auditor requests to be left alone in the records room?

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The most appropriate action is to allow the auditor accompanied access to the room to retrieve the records. In a regulatory context, auditors often need to review records as part of their assessment process. Providing accompanied access ensures that the auditor can effectively perform their duties while maintaining oversight, which also protects the integrity and security of the information.

This approach aligns with standard practices in regulatory audits, where transparency and cooperation are key. By being present, you can also assist the auditor in accessing the specific records they need, potentially speeding up the audit process and ensuring compliance with regulatory requirements.

Denying access altogether or allowing the auditor to be left alone could raise concerns regarding transparency and may lead to complications. It is essential to balance operational confidentiality with the auditors' need to perform their job effectively, making accompanied access the most suitable choice.

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