- 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
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- 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
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