Instrument Hardware Qualification Services

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:

• At installation
• After a move
• After additions, changes, or upgrades to the system
• After planned maintenance (PM)
• After a critical repair
• For a scheduled OQ site requirement
• Before a previously installed system will be used in a regulated test environment for the first time

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:

• Experienced technical support—our trained and certified field service engineers (FSEs) have unmatched experience and knowledge of our Applied Biosystems, Invitrogen, and Ion Torrent platforms. All FSEs participate in rigorous technical training in our global training centers, and receive field support from trained professionals in our R&D, manufacturing, and technical assistance centers (TAC). When your instruments are serviced by our certified engineers, you’ll gain confidence and peace of mind knowing that the work is performed to Applied Biosystems, Invitrogen, and Ion Torrent instrument specifications.
• Helps increase uptime—our experienced FSEs are available and ready to perform Thermo Fisher qualification protocols developed for your instrument. Qualification services typically take less than one day to complete and help reduce laboratory start-up time (or downtime after repairs or scheduled maintenance) so that your lab can get back into production without unnecessary delays.
• Cost-effective compliance—our qualification services are a predictable expense for your laboratory, reducing development and verification time and costs associated with burdening in-house technical resources to document instrument performance.