Document Control and Records Management

This 60-minute module introduces the document control and records management practices required for an effective laboratory Quality Management System. It explains how to distinguish controlled documents from records, manage the eight-stage document lifecycle, apply version control and retention requirements, and use electronic systems securely. Learners will review common audit non-conformities, complete a knowledge assessment, and carry out a practical document-control audit with CAPA effectiveness checks and an audit-ready evidence log aligned to ISO 15189.