Employee Competency Management

Employee Competency Management is the system to ensure that all your personnel are qualified, trained, and competent to perform tasks that affect product quality and compliance. 
 
FDA 21 CFR 211.25 requires employees to have adequate education, training, and experience, with training in CGMP documented. ISO 13485 and ISO 9001 require organizations to define competence requirements, provide training, evaluate effectiveness, and maintain records. 
 
Why it matters: because unqualified personnel are a common root cause of deviations, data integrity failures, and inspection findings.