IQOQ Meaning and
Definition
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IQOQ refers to the abbreviated term for "Installation Qualification/Operational Qualification" used in validation and quality assurance processes. It is a combined term for two distinct phases of validation typically executed in regulated industries such as pharmaceuticals, healthcare, and manufacturing.
Installation Qualification (IQ) is the initial phase that examines and documents the proper installation of a system or equipment. This involves verifying that all components are correctly set up, calibrated, and adhering to the defined specifications. IQ ensures that the system is installed correctly and meets the manufacturer's requirements.
Operational Qualification (OQ) is the subsequent phase that evaluates and confirms that the equipment or system operates effectively and consistently. OQ establishes evidence to support that the device operates within its defined parameters, performs as expected, and meets the operational requirements. It often involves testing various functionalities, environmental conditions, tolerances, and potential failure scenarios.
Together, IQOQ validates that the equipment or system has been installed correctly and functions as intended, providing assurance to regulatory authorities, stakeholders, and users that the system will duly perform its designated functions. The documentation generated during IQOQ serves as crucial evidence to ensure compliance with industry standards, guarantee the validity and reliability of processes, and mitigate potential risks associated with incorrect installations or operational inadequacies.
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