System Access Logs and 21 CFR Part 11

System access logs are an essential component of data management and security in regulated environments, particularly when dealing with electronic records and signatures under 21 CFR Part 11. This regulation outlines the requirements for the management, integrity, and security of electronic records, ensuring that they are trustworthy, accurate, and accessible throughout their lifecycle. System access logs provide a detailed record of who accessed a system, when, and what actions were taken, offering crucial insight into data access, user behavior, and compliance with regulatory standards. In this article, we will explore the importance of system access logs in ensuring compliance with 21 CFR Part 11, how they contribute to security and data integrity, and best practices for maintaining effective access logs in regulated environments. What are System Access Logs? System access logs are records that document who accesses a system, what actions they perform, and when they do so. These logs capture critical information such as: User Identification: The unique ID of the person accessing the system. Timestamp: The exact time and date of system access. Actions Performed: Details about what the user did while logged into the system (e.g., viewed, edited, or deleted records). System Events: Any system events, errors, or security breaches that occurred during the session. Under 21 CFR Part 11, these logs serve as an audit trail, helping organizations demonstrate that their systems and processes are compliant with regulatory requirements related to data integrity, security, and access control.