Trust Your Instrument Qualification to the Company That Designed Your System

Receive Audit-Quality Expert Support, Maximize Your Uptime, and Attain Cost-Effective Compliance


“A properly planned and scoped compliance initiative and validation engagement costs less and is more flexible than a reactive compliance engagement. ”

In regulated industries, compliance with government and international standards requires documented verification that your systems are installed and functioning according to their manufacturer’s intended use. Whether you need Installation Qualification and Operation Qualification (IQ/OQ) or Instrument Performance Verification (IPV), our qualification services provide audit-quality data to share with your regulated body and verify that your instrument is working according to manufacturer’s specifications. This is also a valuable service for laboratories that are not in regulated environments, as it provides added peace of mind that your instruments are working appropriately and producing high-quality data.

 

 

 

All qualification services provide you with a comprehensive package that includes rigorously executed protocol documentation as well as all data collected during the execution of the protocol. Installation Qualification and Operation Qualification (IQ/OQ) and Instrument Performance Verification (IPV) provide:

  • Audit-Quality Expert Support—Life Technologies™ trained-and-certified Field Service Engineers (FSEs) have unmatched experience and knowledge on our Applied Biosystems™, Invitrogen™, and Ion Torrent™ platforms. In addition, they participate in a re-certification process every two years and receive full technical support from both our factory and the trained experts in the Technical Assistance Center (TAC). When your instruments are serviced by best-in-class engineers, you are guaranteed that the work is done to Applied Biosystems™, Invitrogen™, and Ion Torrent™ instrument specs, resulting in increased peace of mind.

  • Maximize Uptime—our experienced FSEs are available and ready to perform verification immediately after installation. Depending on the system or instrument, the service takes less than two days and reduces laboratory start-up time (or downtime after repairs or scheduled maintenance) so that your lab can get back to work without unnecessary downtime.

  • Cost Effective Compliance—our qualification services are a predictable expense for your laboratory, not only reducing your in-house verification time but also the costs associated with burdening in-house technical resources.

 

Validation: Proving suitability for intended use

Computer System Validation; IQOQ is a start point

Method validation

Standard operating procedures (SOPs)

People

Maintaining Validation: Proving ongoing suitability

Re-Qualification Flexible maintenance plans

Limit of Detection

 

Installation Qualification (IQ)

The IQ procedures ensure that instrumentation is delivered and installed according to the stringent specifications set by Life Technologies, which include documenting the shipment integrity, the system components, and compatibility with the system configuration.

We recommend that you have an IQ service performed at the following times:

  • At the time of instrument installation

  • When an instrument is moved to another location or laboratory

  • After functionality is added to the system, such as a hardware or software upgrade

  • After components are added to the system

  • Before a previously installed system will be used in a regulated test environment for the first time (e.g., an instrument used for basic research transitions for use in clinical trials testing)

Operation Qualification/Instrument Performance Verification (OQ/IPV)

The OQ/IPV service verifies and records the instrument’s ability to meet specified performance criteria after installation, repetitive use, relocation of the instrument, or major service events. The OQ/IPV service involves comprehensive testing of the complete system using established conditions and known sample characteristics.

A key benefit of the OQ/IPV is to ensure the accuracy and precision of the instrument. Instruments should be regularly tested to confirm high-quality performance and identify possible problems due to normal wear or inadequate user maintenance.

We recommend that you have an OQ/IPV service performed at the following times:

  • At instrument installation

  • On a periodic basis in accordance with your standard operating procedures

  • After a major repair

  • After relocating an instrument to another laboratory

  • After functionality is added to the system, such as a hardware or software upgrade

  • After any software change that affects system security, data integrity, or administrative controls

  • Before a previously installed system will be used in a regulated test environment for the first time (e.g., an instrument used for basic research transitions for use in clinical trials testing

 

What are Qualification and Validation?

Analytical Instrument Qualification Computer System Qualification

Non-method specific test(s) based upon accepted parameters such as:

  • Precision

  • Detector linearity

  • Accuracy

  • Temperature accuracy and linearity
 

System tests based upon laboratory requirements such as:

  • Security settings

  • Audit trails

  • User/System configuration

  • Change control

  • User training

 

Complete List of Instruments Serviced

Customer has the sole responsibility to ensure that Life Technologies and/or its affiliate(s) products and services, including but not limited to qualification and validation, are adequate to meet customer’s own regulation, certification and other requirements.