UnderFDA 21 CFR Part 11, organizations using electronic systems must ensure thatall system users are trainedto perform their assigned functions before gaining access to the system. The regulation requires documented evidence of training but does not specify how it should be conducted (e.g., exam-based, in person, or language-specific).
TheGCDMP (Chapter: Computerized Systems and Compliance)further clarifies that personnel training should include instruction onsystem functionality, audit trails, data entry procedures, and electronic signaturesto maintain compliance and data integrity. Training must beperformed and documentedbut does not require a specific format or delivery method.
Therefore,option A—Training must be performed—is correct, as it reflects theminimum regulatory expectationper FDA and SCDM standards.
Reference (CCDM-Verified Sources):
FDA 21 CFR Part 11, Section 11.10(i) – Personnel Training Requirements
SCDM GCDMP, Chapter: Computerized Systems and Compliance, Section 5.4 – System Training and Documentation
ICH E6(R2) GCP, Section 2.8 – Qualified Personnel and Training Requirements
