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Technical Note No. 2023. Rev. 1.0NucleoCounter NC202Installation and Operation Qualification Instrument and Materials Specifications Purpose: To specify the instrument, test kit and cassettes being

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Who needs installation and operation qualification?

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Anyone involved in the installation and operation of equipment in a regulated industry such as pharmaceuticals, biotechnology, medical devices, or food and beverages.

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What is installation and operation qualification?

Installation and operation qualification (IQ/OQ) is a process that ensures equipment or systems are properly installed and operated according to manufacturer's specifications and regulatory requirements before being put into use.

Who is required to file installation and operation qualification?

Companies in industries such as pharmaceuticals, healthcare, and manufacturing may be required to file installation and operation qualification for certain equipment or systems.

How to fill out installation and operation qualification?

To fill out installation and operation qualification, companies typically follow a protocol provided by the equipment manufacturer or regulatory agency, which includes documenting installation procedures, performing testing, and completing verification reports.

What is the purpose of installation and operation qualification?

The purpose of installation and operation qualification is to ensure that equipment or systems are installed correctly, perform as intended, and meet necessary quality and regulatory standards.

What information must be reported on installation and operation qualification?

Information reported on installation and operation qualification typically includes equipment details, installation procedures, test results, verification reports, and any deviations or corrective actions taken.

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