Newly purchased equipment and devices must first be approved for installation to determine whether these devices can produce a desired and high-quality product. This certificate is created as a document to confirm the device’s ability to meet the user’s needs. The way the device works depends on its installation method. The installation certificate confirms that the tools or equipment are qualified to function based on the manufacturer’s technical specifications or the installation checklist.

For example, a device may need a certain space for installation to avoid impact or damage. IQ ensures that the environment and installation conditions meet the minimum requirements of a device. Based on FDA’s definition, a competency certificate or IQ is defined as follows: The necessary factors for a system as prerequisites depend on the proper functioning of the device.

What does it take to do a successful IQ?

A successful IQ is usually measured by considering that the installation process of devices or equipment follows the manufacturer’s instructions and meets the user’s needs, and usually includes the following:

• Installation location and sufficient space for the device
• Proper packaging and proper unboxing
• Testing all the components of the device to ensure that they are healthy
• Ensuring the power supply of the device
• Installing accessories
• Documenting device serial number and hardware information
• Review of environmental and operational conditions
• Checking the installation and implementation of software systems and people’s access levels
• Record the date of calibration and validation
• Checking all connections and connections of the device

OQ certification will be applicable when all IQ protocols are met. The purpose of OQ is to match equipment performance to user expectations. In practice, it means identifying and checking the technical specifications of the equipment, which can overshadow the final quality of the products.

During the OQ process, all items in the certificate are tested, and their performance and results are documented. Since OQ is a prerequisite for the acceptance of devices, it can be done only after the implementation of IQ. In general, OQ is a detailed inspection of the installation, operation, maintenance, and support of hardware or software (if applicable). It must be shown that the device’s technical specifications are exactly in accordance with the user’s wishes.

As previously explained, OQ is the examination of equipment and its impact on product quality and ensuring their performance, and often includes the following:

• Temperature or humidity control and their changes
• Engine system and device board
• Safety thermostats and supporting systems
• How to distribute temperature or humidity
• The display and operation of the screen controls
• Fan control and its speed
• Temperature and humidity range

Validation or qualification of device performance. At this step, the relevant expert must test the device and compare the results with the user’s request. PQ tests the entire device instead of testing individual components. The quality or validity of PQ largely depends on the quality and manner of testing. The FDA criteria for a PQ protocol are summarized in two elements:

1. Facilities design and qualification of equipment and facilities
2. Device performance qualification during the production process (PPQ)
3.  

PPQ aims to ensure consistent product quality by recording performance over a specific time period for specific products. And generally includes the following:

• A complete list of data to be recorded or analyzed during testing, calibration, and validation.
• Tests to ensure uniform quality throughout the production
• Approval of the PQ protocol by the relevant department, i.e., quality control

FG Company is a manufacturer of laboratory and pharmaceutical equipment, which supplies the products needed for the production of pharmaceutical companies, medical, food, cosmetic, etc. companies. To assure our customers and guarantee our production devices, all IQ certificates/ It provides OQ and the necessary qualifications to take a big step in the health and quality of laboratories.