Countess® IQ/OQ Test Procedures

Countess® IQ/OQ Certification

Compliance with government and international standards recommends documented verification that your instruments are installed and functioning according to the manufacturer’s specifications. Installation Qualification/Operational Qualification (IQ/OQ) procedures are critical to that process. Invitrogen now offers the test procedures necessary to support the IQ/OQ being performed by your own staff.

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What is IQ/OQ ?

The Installation Qualification/Operational Qualification (IQ/OQ) testing helps ensure that:

  • The instrumentation is installed and is operating according to Invitrogen’s documented specifications
  • Shipping is complete and all of the components of the system have been received
  • The instrument–intended purpose meets expectations (determined following a  comprehensive suite of tests using established conditions and expected results)

Who Needs it?

Customers who require verification in quality management systems such as GCP, GLP, GMP or ISO standards.

  • In regulated industries, compliance with government and international standards involves obtaining documented verification that the instruments are installed and functioning according to the manufacturer’s specifications. The process can be complex, time-consuming, and costly.
  • When you use our Qualification Procedures as part of your overall system validation, you save the time and effort of writing test procedures and performing the steps to ensure that the instrumentation meets its intended purpose.

What is Included?

The IQ/OQ service package includes:

  • A bound, printed copy of test procedures necessary to support the IQ/OQ being performed by your own staff. 
  • The package does NOT include consumables required to perform the procedures.

What Instrument is Supported?

We supply IQ/OQ procedures for the following:

  • Countess™ Automated Cell Counter (Cat Nos: C10227, C10310, and C10311)

IQ/OQ Recommendations

To help maximize the effectiveness of your IQ/OQ procedure, we recommend you do the following prior to the procedure:

  • Review and approve the procedures in accordance with your organizational requirements
  • Ensure that order and user documentation is available
  • Ensure that your laboratory meets Invitrogen’s site preparation requirements

IQ/OQ Procedures Included

Our comprehensive IQ/OQ procedures include the following:

  • Order and System Verification to verify that the instrumentation ordered was received and fully documented
  • User Documentation Verification to verify documentation is recorded
  • Installation Verification to verify the installation and configuration meets specification
  • Firmware and Optional Software Identification Verification to document current versions and verify compatibility
  • Record that instrument is installed in a suitable environment for operation
  • Power Cycle Verification
  • Background Calibration Verification
  • Sample Preparation Verification
  • Instrument Performance Verification

Recommended Times for IQ/OQ

To help ensure optimal performance of your systems and to support compliance, we recommend that you have an IQ/OQ performed at the following times:

  • At instrument installation (if applicable)
  • On a periodic basis in accordance with your SOPs
  • After major relocation of an instrument to another location or laboratory
  • After functionality is added to the system, such as firmware or software upgrade
  • 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 is transitioned for use in clinical trials research)

The IQ/OQ service should be performed by a qualified member of your staff. Upon completion of the service, you should have recorded evidence that the system meets specified performance criteria, traceable and revision-controlled test procedures.