Sierra BioSystems offers comprehensive testing and documentation for GMP facilities that require Installation, Operational, and Performance Qualifications to maintain compliance.
Qualification documentation begins with manufacturing compliance follwed by Installation Qualification which is done to check whether the equipment is built and installed in compliance with design specification, Operational Qualification in which the equipment is verified to operate consistently within established efficacy over the defined protocols, and finally, Performance Qualification to demonstrate that the instrument will produce exceptional product consistently under normal operating conditions.
IQ/OQ/PQ inspections include but are not limited to:
- Instrument condition upon arrival
- Correct electrical specifications such as voltage, amperage, etc.
- Calibration and maintenance
- Sensors operating within OEM parameters
- Ancillary equipment evaluation and calibration inspection
- Liquid and gas pathway integrity
- Comprehensive failsafe testing
- Demonstrate end-user defined requirements
- Completed synthesis and analysis of product