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IQ/OQ of Monitoring Equipment

Performing IQ/OQ of your monitoring equipment is critical for success within FDA regulated environments. And while IQ/OQ’s can be tedious, we have a solution.

Ellab has staff ready to be deployed to help with the installation and qualification of your Ellab monitoring equipment. With general procedures in place and vast experience performing IQ/OQ’s, we stand ready to ensure full functionality and compliance.

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Valsuite-Validation software

Our Experiences Include

  • Documentation written in alignment with GAMP 5 life cycle guidelines
  • Qualification of monitoring hardware and software
  • Qualification of transmitters, receivers, repeaters and other communication modules in accordance with GDP criteria
  • Ensuring that alarm functionalities work between the hardware and software
  • On-site as well as off-site options
  • Time-saving procedures through dedicated and experienced staff

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Hardware Installation Qualification (IQ)

During the IQ phase, Ellab staff records all the equipment present, serial and part numbers, location and the individuals conducting the tests. We then ensure that your monitoring equipment is properly installed, configured and communicating with the EMS monitoring software.

IQ of Monitoring Equipment Includes:

  • Checking power supply connectivity – internal, external or both
  • Testing network connectivity – hard-wired ethernet or Wi-Fi
  • Device mounting for optimal wireless performance
  • Providing calibration certificates (if necessary)
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Hardware Operational Qualification (OQ)

For the OQ phase, Ellab staff verifies that all hardware works as intended to support the critical parameters of your system. Ensuring that data comes through and is shown accurately, and alarms go off when required.

OQ of Monitoring Equipment Includes:

  • Checking power backup functionality
  • Ensuring stable data transmission
  • Ensuring a live data view
  • Checking data graphs
  • Qualifying alarm functionality
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Need IQ/OQ of Your Monitoring Software?

Ellab also performs IQ/OQ of our software to ensure all-around compliance and functionality

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