Date Published:
Thu, 11/16/2000GMP for API manufacturers. See sections 2.22 (10), 2.23 (8), 5.4, 6.1, 12.1, 12.2, 12.3, 12.6, 13.11, and 13.13 for specific computer and validation requirements. Topics include validation, qualificiation, documentation, security, record protection, record retention, audit trails, change control, SOPs, back-ups, and incident investigation.