WPR2864-Showcase

Get documentation that supports regulatory requirements and industry standards for instrument compliance

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: Instrument 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:

  • 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
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:
  • Verifies and documents: 
  • - That all instrument components and accessories match the order invoice and shipping manifest
  • - That the customer site meets the requirements for instrument installation
  • - The configuration of all components of the instrument system, including software and computer
  • - That upon installation, the instrument system is able to meet all performance specifications; comprehensive sub-system testing is included in the verification
  • Establishes the initial accuracy and performance of the instrument
  • At installation
  • After a move requiring re-installation
  • After major additions, changes, or hardware/software upgrades that require capturing the instrument configuration during re-installation
  • Installation verification
  • Order and system verification
  • Calibrated tools certification
  • Component verification
  • Customer training verification
  • Documentation verification
  • Hardware operation verification
  • Maintenance verification
  • Software verification
OQ/PQ or OQ/IPV*
Post-installation qualification service When are qualification services recommended?  Comprehensive audit style documentation for: 
  • Verifies and documents: 
  • - The configuration of all components of the instrument system, including software and computer
  • – The operational performance of all relevant sub-systems using comprehensive testing
  • – That the instrument system is able to meet all performance specifications after critical service or planned maintenance events
  • Helps ensure the continued accuracy and precision of the instrument
  • After planned maintenance (PM)
  • After a critical repair
  • After minor additions, changes, or hardware/software upgrades
  • According to SOP or site quality requirements
  • Before a previously installed system will be used in a regulated test environment for the first time
  • Calibrated tools certification
  • Component verification
  • Customer training verification
  • Documentation verification
  • Hardware operation verification
  • Maintenance verification
  • Software verification
  • System performance verification
* IQ: Instrument Qualification, OQ: Operational Qualification, IPV: Instrument Performance Verification, PQ: Performance Qualification.

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 type

  • Capillary electrophoresis (CE) instruments
  • Cell imaging instruments
  • DNA/RNA purification instruments
  • Flow cytometers
  • High content screening (HCS) systems
  • Imaging and microscopy instruments
  • Laser capture microdissection instruments
  • Microarray systems
  • Microplate dispensers, washers, & readers
  • Next-generation sequencing (NGS) instruments
  • PCR instruments (thermal cyclers)
  • Protein electrophoresis and western blotting instruments
  • Real-time PCR instruments
  • Sample card processing instruments
  • Instruments other than Applied Biosystems, Invitrogen, or Ion Torrent brands†
†Please note, our qualification services are available exclusively for instruments and equipment manufactured or available through Thermo Fisher Scientific. For qualification services on instruments and equipment other than Applied Biosystems, Invitrogen, and Ion Torrent brands, please see Thermo Scientific qualification services for lab equipment.

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.

Resources

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