Qualification

N-Wissen GmbH

Laboratory & Industrial Solutions

N-Wissen GmbH

Service > Qualification

The 3Q Service

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