Delivery Process
Ensuring the facility and systems perfom as specified.
Commissioning:
- Defines and controls all commissioning activities
- Performed for non-GMP systems
- A test manager manages the commissioning activities
Qualification:
- Qualification SOP's
- Validation Master Plan (QMP)
- Design Qualification (Design Reviews)
- Factory Acceptance Testing (FAT)
- Installation and Operation Qualification (IQ and OQ)
- Deviation Handling and Change Control