Personnel Training — §11.10(i)

Personnel Training and Qualification. All individuals who develop, maintain, or use electronic record and electronic signature systems subject to 21 CFR Part 11 shall be trained and qualified to perform their assigned tasks, in accordance with §11.10(i). The training program shall include: (a) initial training for all new users prior to being granted system access, covering the specific system functionality relevant to their role, data integrity principles, electronic record and signature requirements, and the organization's Part 11 policies and procedures; (b) training on the regulatory requirements of 21 CFR Part 11, including the legal equivalence of electronic signatures to handwritten signatures, the prohibition against falsifying electronic records or signatures, and the consequences of violations; (c) role-specific training for system administrators covering security configuration, user account management, audit trail review, and system maintenance procedures; (d) training for IT personnel and developers on secure system design, validation requirements, and change control procedures applicable to Part 11 systems; (e) retraining whenever there are significant changes to the system, procedures, or regulatory requirements; (f) periodic refresher training at defined intervals, not to exceed two (2) years; and (g) documentation of all training activities, including the training date, subject matter, trainer identification, training method, and evidence of trainee competency assessment (e.g., examination, practical demonstration, or documented observation). Training records shall be maintained for each individual and shall be available for regulatory inspection.