IQ, OQ, PQ, DQ Validation
IQ, OQ, PQ, DQ of Laboratory Equipment and Instruments throughout the UK – Equipment Qualification (IQ/OQ/PQ/DQ):
UK lab services is a company providing medical equipment servicing and repair throughout the UK and Europe.
IQ, OQ, PQ, DQ
There are four types of protocol that are used to validate instrument performance and satisfy regulatory requirements.
IQ which refers to Instrument qualification is the pre-installation detail that the equipment, 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 the 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 stands for “Performance Qualification” which means that the application, under real-life conditions, consistently produces products which meet all predetermined requirements. The PQ is the final test before production (potentially the most important test document you will ever run), testing that the solution works fully in the live environment using live data, and should be based back on a workflow model from your User Requirements Specification.
DQ document qualification. 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.
On top of the IQ/OQ/PQ/DQ you should ensure that you have other key documents including The Validation Master. This will form the detail and coverage of the documentation that you need.
UK Laboratory Services is able to customise and carry out all your validation requirements to cover your full range of medical equipment.
- Manage and schedule IQ, OQ, PQ, DQ for all your equipment by request
- Work closely with you to solve problems and adhere to individual requests
- Achieve best practice standards to maintain the highest level of client satisfaction
- Advance notice of all forthcoming IQ, OQ, PQ, DQ visits
- Post customer contact to ensure client satisfaction
Why Choose Us?
- One dedicated point of contact for all your validation requirements
- UK wide coverage for a fast response for all your validation needs
- Annual validation contracts to cover all your equipment requirements
- Intuitive, industry-standard management systems used
- Over 50 years combined experience in IQ, OQ, PQ, DQ