Which documentation is essential for maintaining compliance in regulatory affairs?

Standard operating procedures (SOPs) are essential for maintaining compliance in regulatory affairs because they provide a written framework for processes that must be followed to meet regulatory requirements. SOPs ensure that all activities are conducted consistently and in accordance with laws, regulations, and industry standards. They serve as a critical reference for staff and help organizations demonstrate adherence to regulatory expectations, reducing the risk of non-compliance and associated penalties.

SOPs cover a wide range of operational aspects, including quality management, safety protocols, and data handling, all of which are vital for maintaining compliance in industries such as pharmaceuticals, medical devices, and biotechnology. This documentation is particularly important during inspections and audits, as it evidences the organization's commitment to regulatory compliance and showcases the processes in place to uphold those standards.

While other documents like marketing plans, financial reports, and human resources policies are important for a business’s functionality, they do not specifically address the regulatory compliance process in the same comprehensive manner as SOPs do. Thus, they do not serve the vital role that SOPs play in ensuring ongoing compliance in regulatory affairs.