QMS DOCUMENTATION

Specific documents created by GCI include:

• Qualification / Validation Plans

• Hardware Design Specifications

• Hardware Acceptance Test Specifications

• Software Design and Software Module Design Specifications

• Software Integration Test Specifications

• Instrument Specifications

• Detail Design Documents:

• Plant and Equipment Layouts

• Process and Instrument Diagrams

• Loop or Instrument Schedules

• Process Sequences/Logic/Interlocks

• Interconnection Drawings

• Installation Qualification for Development and Test Environments

• Operational Qualifications for FAT/SAT

• Installation Qualification for Production Environment

• Performance Qualification

• Eventful / Uneventful Testing

• Test Summary Reports

• System Build Checklists

• System Acceptance / Commissioning Reports

• Traceability Matrices

• Business Continuity Plans

• Calibration Reports