What is the function of a document control system in regulatory affairs?

A document control system plays a crucial role in regulatory affairs by managing critical documents in a way that ensures compliance with applicable regulatory standards. This involves not just storing documents, but actively maintaining them, updating them when necessary, and ensuring that the correct versions are accessible to relevant stakeholders at all times.

The function of managing documents effectively includes identifying which documents are essential for compliance, establishing procedures for revision and approval, and maintaining audit trails to demonstrate adherence to regulatory requirements. This systematic approach is fundamental in industries that are heavily regulated, such as pharmaceuticals and medical devices, where accuracy and up-to-date information are essential for product safety and efficacy.

While some might consider archiving documents permanently, this does not align with the primary goal of a document control system. Additionally, monitoring employee performance regarding documents, or eliminating the need for retention policies, strays from the core function of ensuring document compliance and accuracy. The focus is primarily on governance and management to uphold regulatory integrity, making the correct answer the most aligned with the principles and practices in regulatory affairs.