Computer System Validation
By operating in accordance with existing laws and guidelines in the field (GAMP, PIC / S Guidance, FDA 21 CFR Part 11, etc.), CSV Life Science can provide the following services:
• Quality system outline
• Policy outline
• Computer system validation
• VMP and VP of computerized systems
• User requirements outline and project documents reviews
• Suppliers audits
• Risk analysis-based approach
• Support to development and testing
• GAP analysis of existing systems and corrective action plans (CAPA plan)
• Validation and validation reports
• Administrative SOPs definition
• Training on rules and guidelines
