Computer System Validation

• Computer System Validation Strategy
• Best Practices for Cost Saving & Quality of 21 CFR Part 11 Compliance Strategy
• Validation Templates and System Specific Packages
• Ongoing Adaptation of Risk Based Computer Validation Approach to Current Regulatory Expectations
• Computer Validation of Global and Local IT Systems (e.g. ERP, MES)
• Laboratory & Process Control Systems Validation
• CSV Best Practices
• User Requirements and Process Mapping
• Data Migration Verification Strategy and Execution
• System Testing (Unit & Integration Tests, UAT)
• Validation Test Planning, Execution & Documentation
• Best Practices Procedures to Maintain the Validated Status
• Change Management & Periodic Review
• 21 CFR Part 11 & EU GMP Annex 11 Assessments
• Risk-prioritized & Turnkey Remediation Projects
• 21 CFR Part 11 Inspection Readiness Projects