Validation

We follow GAMP5 and Specialize in Controls and Computer Systems Validation

Documents we have and can generate:

• Validation Master Plans
• Requirements Definition
• Detailed Design Specifications
• Test Plans
• Traceability Matrix
• Generate Standard Operating Procedures (SOPs)
• Generate Installation Qualification Protocols (IQ)
• Generate Operational Qualification Protocols (OQ)
• Generate Performance Qualification Protocols (PQ)
• Perform Protocol Execution
• Perform Validation Support
• Perform Retrospective Validation
• CFR Part 11 Compliance and Validation
• Generate Summary Reports