Operational qualification of equipment takes place in two separate phases. The first phase is Factory Acceptance Testing that is typically conducted in conjunction with the customer to ensure the equipment is operating according to the manufacturer’s standards. Site acceptance testing is a verification of the factory acceptance test and often takes place after the equipment has been installed and verifies that nothing has changed since the equipment was tested at the factory.
Phases of Operational Qualification
Phase 1: Factory Acceptance Testing
Conducted in conjunction with the customer & ensures the equipment is operating according to the manufacturer’s standards.
Phase 2: Site Acceptance Testing
Verification of the factory acceptance test & often takes place after equipment installation. Verifies nothing has changed since the equipment was tested at the factory.
- Onsite Training
- On SOP Usage with Operator Certification
Standard Operating Procedures
- Operations of Equipment
- FAT (Operational Qualification)
- SAT (Installation Qualification)
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- GMP Equipment Commissioning and Training shall not exceed three days and is for one piece of equipment. If the commissioning and training exceeds this time frame, there will be additional costs per day of training.
- Additional training will be charged $2500 USD per day (Part #80-9614)
- Commissioning & Training is available for extraktLAB equipment only.
- The customer is responsible for preparing the site and all personnel in advance of training start
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