Computer System Validation

 

 

Computer System Validation are categorized as follows:

• Computer Systems Validation Methodology
• Controls / Automation / Integration
• 21 CFR Part 11 Gap analysis / Assessment/ Corrective Action Plans
• System Development Life Cycle Management (SDLC)
• Validation Master Plans
• Factory Acceptance and Site Acceptance Tests (FAT / SAT's)
• User Requirement Specifications (URS)
• Traceability Matrix (TM)
• Functional Specification (FS)
• Design Specification (DS)
• Software Vendor Audit & Report
• IQ, OQ, PQ
• Source Code Review and Testing
• Standard Operating Procedures (SOP's)
• Development Test Plans & Report
• Validation Reports
• Impact Assessment / Risk Management

 

 

DMC Firewall is developed by Dean Marshall Consultancy Ltd