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Engineering Service

  • Documentation Support
  • Comprehensive Work Instructions
  • Operation Manuals
  • Calibration Guides
  • Maintenance Guidelines
  • Engineering Drawings
  • Assembly Layouts
  • Bill of Materials
  • Controls Schematics
  • Spare Parts Recommendations
  • User Requirements Specification Development
  • General Equipment Specification Development

  • Project Management Services
  • Defined project objectives/deliverables
  • Work Breakdown Structure
  • Integrated Project Plans
  • Defined Critical Path
  • Project Risk Analysis
  • Short Term and Long Term Objectives Update
  • Qualification
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Installation and Operation
  • Qualification (IQ/OQ)
  • Process Validation (PV)
  • Software Validation (SV)
  • GAMP 4

  • Regulatory Compliance Support
  • CE marking
  • FDA regulation