Areas of Specialty

• Computer System Validation
• Process Validation
• Equipment Qualification
• Cleaning Validation
• IT Infrastructure Qualification
• Facility/Utility Commissioning and Qualification
• Analytical and Microbiological Methods Validation
• Specific Service Offerings
• Validation Program Development
• Validation Planning
• Vendor Auditing
• Risk Assessment and Mitigation
• User Requirements Gathering and Documentation
• System Design Documentation (FRS, DS)
• Qualification Protocol (IQ, OQ, PQ) Development
• Qualification Protocol Execution
• Validation Reporting
• Traceability Matrices
• SOP Development and Review
• Validation Project Management
• Validation Gap Analysis and Remediation