Installation Qualification (IQ)
- Delivery description: instrument, components, manufacture, model, serial number, software, etc
- Delivery condition: including inspection of instrument, software, manuals, accessories, etc
- Comparison of equipment, as received, with purchase order
- Unpacking the equipment and checking for any damage or missing
- Verifying environmental conditions
- Installing of equipment and power up
- Check completeness of documentation
- Installation Verification
- Network and Data Storage
Operational Qualification (OQ)
- Checking fixed parameters
- Data storage, Backup and Archiving (if applicable)
- Instrument Function Tests
- Perform initial calibration of equipment
- Document equipment settings
- Adjustment of the instrument will be performed in order to comply with manufacturers specifications (If applicable)
Performance Qualifications (PQ)
- Define performance criteria and test procedures (SOP)
- Select critical parameters
- Define test intervals, e.g. daily, weekly
- Define corrective actions in case of non-conformance
- Performance Verification (PV)
- Define re-qualification activities such as Preventative Maintenance, Calibration, etc.
- Define re-qualification frequency such as annually or semi-annually