As Thermo Fisher Scientific designs and produces Applied Biosystems, Invitrogen and Ion Torrent instruments, it understand the system better than anyone. Users can be certain that the instruments are mounted, running and functioning according to the manufacturer’s requirements while using the instrument qualifying services.
To check instrument performance, the manufacturer-trained and qualified field service engineers (FSEs) will undertake complete testing of the instruments utilizing verified tests, certified tools and defined standards. To help users meet regulatory requirements and industry regulations, the designers provide audit-style documentation.
Users must entrust the vendor that created the system with the hardware qualifications. Science absolutely cannot wait for noncompliant instruments.
What are instrument hardware qualifications (IQ/OQ/PQ or IPV)?
With the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) or instrument performance verification (IPV) services, users can ensure that their instrument meets manufacturer performance criteria.
- IQ: Provides proof and confirmation that the instrument was supplied and fitted in accordance with the manufacturer’s requirements.
- OQ: Gives verifiable proof that the instrument subsystems are functioning properly. Checks if an instrument’s functioning fulfills the manufacturer’s operational criteria.
- PQ or IPV: Provides written proof that the instrument system can perform efficiently and consistently within performance parameters. Assists in maintaining assurance in results by ensuring that an instrument’s accuracy and consistency are retained.
- Re-qualifications (OQ or OQ/PQ or OQ/IPV): Provide verified proof that the instrument appears to function as the manufacturer intended. Yearly, or according to the user’s SOP needs, once an initial IQ, OQ, PQ, or IPV has been accomplished.
*IQ: Installation Qualification, OQ: Operational Qualification, PQ: Performance Qualification, IPV: Instrument Performance Verification.
Video Credit: Thermo Fisher Scientific Applied Biosystems, qPCR