Computer Software Validation (CSV)

We can assist you with your IQ/OQ/PQ validation for your computer systems so it will meet FDA requirements and industry standards.

• LIMS
• MES/Electronic Batch Records
• SCADA (Supervisory Control and Data Acquisition)
• Environmental Monitoring
• Laboratory Equipment
• SAP and ERP systems
• Training Systems (e.g. ComplianceWire)
• Electronic Document Management Systems (Documentum)
• Sales Force Automation
• Clinical Research applications
• Change Control Systems
• Investigation Systems (TrackWise, ETQ)
• Manufacturing Automation (WonderWare)

We can develop computer validation documents necessary to complete your validation package such as:

• Validation Plans
• 21 CFR Part 11 Assessments
• Risk Assessments
• IQ/OQ/PQ Test Scripts
• Disaster/System Recovery
• User Requirements
• Functional Requirements
• Traceability Matrix
• Technical Architecture Documents
• Design Documents
• Configuration Specifications
• User Guides
• SOP Development and Business Process Improvement
• Adequate deviation documentation and resolution