Compliance - Equipment Qualification (IQ/OQ/PQ & DQ)

Microlab Technologies Equipment Qualification Services provide, at your location, the most efficient way to achieve and maintain compliance. In addition, we will provide full documentation by supplying reports on installation, of the operational and performance qualification of your equipment.

Your advantages:

• Issue of all certificates and documentation, 100% traceable
  (click here to view a report specimen)
• Test instruments qualified by UKAS accredited laboratories
• Compliance with GLP/GMP requirements
• Microlab Technologies risk Assessment

IQ, OQ, PQ & DQ
There are three types of protocol that are used to validate instrument performance satisfies regulatory requirements.
IQ which refers to Instrument qualification is the pre-installation detail that the equipment, its component parts and location, are fit for the purpose and satisfy the objectives of the user to carry out the intended function to expected standards.
The IQ qualifies the equipment is installed correctly with tubing, fittings, syringes and valves connected appropriately
This Pre-qualification checks that all appropriate consumables relative to the agreed use, manufacturer’s documentation, conformity and calibration detail is present. Upon delivery the engineer will:

• Confirm all components are delivered as ordered.
• Review  hazard and safety precautions for area of use including materials that may come into contact with the instrument and personnel
•  Install hardware including all tubing’s, syringes and valves.
•  Configure and install program application functions.
•  Conduct leak test.

OQ which refers to Operations Qualification carried out by the manufacturer or supplier at installation or service interval to verify the performance criteria presented by the manufacturer, to confirm the instrument satisfies its agreed metrics, is valid in the working environment by verification against traceable references.
The engineer will:

• Assure the system is functioning to acceptable limits by testing relevant instrument specification parameters and ranges as determined by Microlab Technologies Instrument Performance Validation protocol.
•  At the completion of the OQ all of the operational tests are documented, results validated, all relevant certificates completed and signed.
•  Once completed the engineer will provide instrument familiarisation training to confirm you are ready to run the instrument with confidence
• The scheduling of service and calibration intervals which are then diarised automatically to assure testing at next interval

PQ which refers to the test or validation protocol carried out by the user, offering documentary evidence that the instrument is maintaining the agreed values.

DQ  or Document Qualification should comprehensively describe:

• The complete maintenance history, system history and inventory of components and documentation
• Verification of components’ installation.
• Performance verification of laboratory equipment for routine R&D, QA/QC, EPA, FDA and client compliance.