What does the control of documents and records ensure in regulatory affairs?

The control of documents and records in regulatory affairs is crucial for ensuring the standardization of operational procedures. This involves maintaining a systematic approach to creating, reviewing, approving, and distributing documents. Standardization helps ensure that all stakeholders in the organization follow the same procedures, leading to consistency in processes and compliance with regulatory requirements.

By having controlled documents and records, organizations can implement standardized practices that comply with regulations and ensure that employees are following the latest approved protocols. This consistency is vital for maintaining quality, safety, and efficacy of products, especially in highly regulated industries such as pharmaceuticals and medical devices. The standardization also facilitates training, as all personnel can refer to the same up-to-date documents for guidance in their roles.

In summary, the correct answer emphasizes how controlled documentation underpins best practices in regulatory affairs by promoting a uniform approach to procedures and helping organizations remain compliant with regulatory guidelines.