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Installation Qualification (IQ)

Documents which establish that the critical components of a system are installed correctly and in accordance with the design documentation requirements.

Becky Whitney - Job Role

Installation Qualification (IQ) is a crucial step in the validation process, particularly in industries such as pharmaceuticals, biotechnology, medical devices, and manufacturing, where the precision and reliability of equipment are essential. IQ is part of a broader validation process and ensures that equipment and systems are installed correctly and meet the required design specifications.

Key aspects if Installation Qualification

Here are key aspects of Installation Qualification:

Documentation Review

Before the installation process begins, all relevant documentation, including equipment specifications, user manuals, and installation procedures, is reviewed to ensure compliance with the intended use.

Site Preparation

The installation team ensures that the installation site is properly prepared to accommodate the equipment. This includes verifying that the environmental conditions, such as temperature and humidity, meet the equipment’s requirements.

Verification of Components

All components and parts necessary for the equipment installation are checked for completeness and accuracy. This includes confirming that the equipment received matches the specifications outlined in the purchase order.

Equipment Installation

The equipment is physically installed at the designated location according to the manufacturer’s instructions and any applicable industry standards. This includes proper placement, electrical connections, plumbing, and structural support.

Calibration and Testing

Once installed, the equipment undergoes calibration and testing to ensure that it functions as intended. This includes verifying that the equipment’s measurements and performance meet the specified criteria.

Documentation and Records

Detailed records of the installation process, including photographs, checklists, and test results, are maintained. These records serve as evidence that the installation was carried out correctly.

User Training

Personnel who will operate or maintain the equipment receive training to ensure they understand its operation, maintenance requirements, and safety protocols.

Change Control

Any deviations from the installation plan or unexpected issues that arise during the installation process are documented and evaluated for their impact on the equipment’s functionality.

Final Review and Approval

After completing the installation and associated testing, a final review is conducted to confirm that the equipment is installed as per specifications. Approvals from relevant stakeholders are obtained.

IQ Report

A comprehensive IQ report is generated, summarising all aspects of the installation process, including deviations, corrective actions, and approvals. This report serves as a critical document for regulatory compliance and quality assurance.

The role of Installation Qualification

Installation Qualification is typically the first step in a series of validation activities, followed by Operational Qualification (OQ) and Performance Qualification (PQ), which further assess the functionality and performance of the equipment during actual operation. Together, these validation activities ensure that equipment and systems operate reliably and consistently, meeting the required quality and regulatory standards.

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