GAMP Design Documents

Comprehensive and clear design documents are the foundation of a successful automation project.  By adhering to the standards defined by GAMP 4/5, G7 Automation is able to implement a design package that is manageable and ensures traceability to the user requirements.

• User Requirements Specification (URS)
• Functional Requirements Specification (FRS)
• System Communication Architecture
• Panel Production Drawings (PPD)
• Instrument Loop Diagrams (ILD)
• Instrument Installation Details
• Field Instrument Design Specification (FIDS)
• Software Design Specification (SDS)
• Computer Systems Design Specification (CSDS)
• Software Factory Acceptance Test (SFAT)
• Panel Factory Acceptance Test (PFAT)
• Onsite System Acceptance Test (SAT)
• Custom User Manuals
• System Standard Operating Procedures (SOP)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Process Qualification (PQ)
• Project Validation Plan (PVP)