Change Control and 21 CFR Part 11

Change control is a critical process for organizations that operate in regulated industries, particularly those adhering to 21 CFR Part 11. This regulation governs the use of electronic records and electronic signatures, requiring that organizations maintain a rigorous framework for controlling changes to critical systems and processes. Change control ensures that any modifications made to systems, procedures, or data are carefully managed, documented, and approved to maintain the integrity, authenticity, and security of electronic records. This article explores the importance of change control under 21 CFR Part 11, its key requirements, and best practices for effectively managing changes in a compliant manner. What is Change Control? Change control refers to the systematic approach used to manage modifications to systems, equipment, procedures, and software in regulated environments. In the context of 21 CFR Part 11, it ensures that any changes made to systems handling electronic records and signatures are properly reviewed, approved, and documented to maintain the accuracy, reliability, and security of the records. The change control process helps prevent unintended consequences or errors that could affect data integrity, compliance, or product quality. Effective change control provides traceability and accountability for every change, making it easier to demonstrate compliance during audits or inspections.