Get documentation of instrument compliance with regulatory requirements and industry standards.
We know Applied Biosystems, Invitrogen, and Ion Torrent instruments better than anyone, because we design and manufacture them. With our instrument qualification services, you can be confident that your instruments are installed, operating, and performing according to manufacturer’s specifications.
Our manufacturer-trained and -certified field service engineers (FSEs) will conduct comprehensive testing of your instruments using verified tests, certified tools, and developed standards to verify instrument performance. Reliable, audit-style documentation is provided to help you meet regulatory requirements and industry standards.
Trust your hardware qualifications to the company that designed your system. Request your quote for qualification services today—because science can't wait on noncompliant instruments.
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Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) or instrument performance verification (IPV) services verify and document your instrument’s ability to meet manufacturer design specifications for performance.
IQ—provides documented evidence and verification that the instrument has been delivered and installed according to manufacturer’s specifications
OQ—provides documented verification that the instrument subsystems are operating as designed. Verifies that the functionality of an instrument meets the manufacturer’s operational specifications.
PQ or IPV—provides documented verification that the instrument system can perform effectively and reproducibly within performance specifications. Helps ensure confidence in results by verifying that the accuracy and precision of an instrument is maintained.
Re-qualifications (OQ or OQ/PQ or OQ/IPV)—provide documented verification that the instrument continues to operate as specified by the manufacturer. Typically performed annually after an initial IQ, OQ, PQ, or IPV has been completed, or according to user’s SOP requirements.
* IQ: Installation Qualification, OQ: Operational Qualification, PQ: Performance Qualification, IPV: Instrument Performance Verification.
Qualifications (IQ/OQ/PQ or IPV) are required for laboratories that operate within a quality management system, comply with global standards (e.g., GLP, GCP, GMP, ISO 17025, and ISO 15189), and/or follow country-specific regulations (e.g., US FDA 21 CFR Part 11, CLIA, and CAP). Qualifications provide documented verification that laboratory instruments are installed and operating according to the manufacturer’s performance specifications. Performing these tests on your own can be complex, time-consuming, costly, and challenging to complete.
A properly planned and scoped qualification service is more flexible than a reactive engagement due to non-compliance. By providing peace of mind through testing and documentation to help ensure that instruments and equipment are working appropriately and producing high-quality data, qualifications are important to every laboratory, even those not operating in a regulated environment.
IQ/OQ/PQ or IPV qualification services include comprehensive testing of the instrument system using verified tests, certified tools, and developed performance standards. Whether you require IQ, OQ, PQ or IPV, our qualification services provide audit-style documentation that can be shared with your regulating or certifying body to verify that your instrument is operating within the manufacturer’s design specifications.
Instruments should be regularly tested to confirm high-quality performance and to identify possible performance problems due to normal use or potential component failure. Events requiring service include:
|Description||Check points||Services included|
|IQ/OQ/PQ or IQ/OQ/IPV*|
|Complete qualification service||When are qualification services recommended?||Comprehensive audit style documentation for:|
|OQ/PQ or OQ/IPV*|
|Post-installation qualification service||When are qualification services recommended?||Comprehensive audit style documentation for:|
A properly planned and scoped qualification service is more flexible than a reactive engagement due to non-compliance.
To maintain a qualified system, the following Applied Biosystems, Invitrogen, and Ion Torrent instruments† should receive regular qualification services to confirm high-quality performance and to identify possible problems due to normal wear or potential component failure:
Instrument qualification services performed by Thermo Fisher Scientific provide you with a comprehensive documentation solution that includes rigorously tested protocols executed by a certified field service engineer. These services feature:
For Research Use Only. Not for use in diagnostic procedures.