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- Operation & Maintenance - Responsibilities and Definition
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Design
- C&Q planning
- Estimating and scheduling
- User requirement specification
- Project change Management
- cGMP design reviews and design qualification
- System boundary definition
- System and component criticality assessments
- Equipment/automation service provider procurement
- Construction & vendor quality control plans
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Construction
- Commissioning test document/protocol/procedure development
- Qualification protocol preparation
- Construction Quality Control
- Equipment and automation factory acceptance testing
- Material receiving checks
- Installation verification
- Walkdowns, punch listing and mechanical completion sign off
- Documentation assembly and turnover
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Commissioning & Qualification
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Operation & Maintenance
