Change Control Management

Change Control Management is the formal process to evaluate, approve, implement, and document changes that may impact product quality, safety, or compliance. 

FDA 21 CFR 211.100 requires written procedures for production and process control, and that changes are reviewed, justified, and approved before use. ISO 13485 and ISO 9001 require organizations to control changes to processes, documents, equipment, and quality system elements to prevent unintended impact. 

Why it matters: uncontrolled changes are a common root cause of deviations, audit findings, and recalls.