Validation Center™

GCP for pharmaceuticals. See sections 1.22, 4.9.3, 5.5.3, and 6.4.9 for specific computer and validation requirements.  Topics include audit trails, system validation, system SOPs, and back-ups.

GMP 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.