What Is IQ OQ PQ in Software Validation

If you work in a business regulated by a government agency, once you’ve implemented or upgraded your LIMS, ELN, or CDS, you need to validate it for your intended use. One part of the validation process that often seems confusing to our clients is the IQ, OQ, PQ testing. This blog will demystify these validation protocol test scripts.

When your laboratory operates in one of the regulated businesses, such as pharmaceuticals or food and beverage, it is critical that you validate your lab informatics system to ensure that it is fit for purpose. When a regulatory agency (such as the U.S. Food and Drug Administration or Health Canada) comes to audit your facility, you will need to have the proper documentation that shows you have performed this validation. There is a lot of documentation needed to complete the picture of a validated system; however, when it comes to providing the evidence that your system operates as intended and is fit for purpose, validation protocol test scripts are critical.

What Are Validation Protocol Test Scripts?

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Validation protocol test scripts provide a standard framework for the testing process. Each step in the testing process verifies specific pieces of the planning and specifications that were used to design the system. This is seen in the classic V model that is used in the GAMP guidelines. The left side of the model addresses the requirements and specifications that are required to define and build a system. The right side of the model addresses the associated testing that is required to verify the requirements and specifications.

V Model

What Are IQ (Installation Qualification) Test Scripts?

IQ test scripts ensure that the laboratory informatics system is received and properly installed in your environment based on the vendor installation requirements, and that the environment is suitable for the operation of the laboratory informatics system. The system is usually first set up in a test or validation environment to perform this testing. Vendors often provide IQ test scripts and associated documentation; however, that documentation should be reviewed before it’s executed to make sure there are no changes required to address your specific environment.

What Are OQ (Operation Qualification) Test Scripts?

OQ test scripts demonstrate that the laboratory informatics system will function according to the operational specifications in its final operating environment, based on how it was developed. This testing confirms that all functionality defined in the Functional Requirements Specification is present and working as it should, and that there are no bugs. OQ testing also confirms that design elements not tested during IQ testing, such as configuration and customization, also work as they should. Vendors often provide OQ test scripts and associated documentation for the out-of-the-box functionality of their system, based on how they developed it. However, once installed, if there are any configurations and/or customizations made for your specific intended use, that functionality should also be addressed in supplemental OQ test scripts to verify it meets the functional specifications.

What Are PQ (Performance Qualification) Test Scripts?

PQ test scripts (sometimes referred to as user acceptance testing) demonstrate the overall intended use of the system according to your procedures and processes. They are derived from the User Requirements Specification and should reflect the day-to-day or end-to-end use of the system in your environment. PQ test scripts are executed in an environment that simulates your production environment. PQ testing also verifies that the LIMS, ELN, or CDS is fit for its intended purpose, operates in accordance with defined standard operating procedures, performs according to the user requirements, and complies with 21 CFR Part 11. This testing will also look at the support environment within which the system is to operate, for example training or maintenance. Vendors do not often provide PQ test scripts or associated documentation, as it is based on your intended use, processes, and procedures.

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When and How Should You Perform IQ OQ PQ Testing?

All testing is done after the system requirements have been gathered and the system is ready to be installed. A test plan or validation plan should include the scope of the testing and the testing levels, which are determined by a risk assessment. The test plan also includes staffing and software requirements, roles and responsibilities, and reports and metrics.

The testing itself consists of test cases that are written specifically to address each aspect of the user and functional requirements. The order of testing starts with the IQ, then the OQ, and finally the PQ. It is important that the installation of the system be verified before any functional testing is performed. It is a best practice that any performance testing occurs after operational testing so that any potential issues with basic functionality can be addressed before verifying end-to-end testing of your processes.

Webinar: "Overcoming Informatics Validation Challenges through Proper Planning"

Why Do I Need IQ OQ PQ?

Proper IQ, OQ, and PQ testing is critical to demonstrate to any regulatory body that your LIMS, ELN, or CDS has been properly validated and that it is fit for your intended purpose. This is necessary if your company desires to do business in one of the regulated industries. Failure to properly validate your laboratory informatics system can result in unnecessary rework at best and in an FDA audit or production shutdown at worst.

Understanding the role of IQ, OQ, and PQ testing and how each relates to specific parts of the validation process can help you get the most out of your laboratory informatics investment.


Do you have more specific questions about IQ, OQ, PQ test scripts and how they should be applied in your validation process? If so, share them below.

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7 responses to “What Is IQ OQ PQ in Software Validation”

  1. LEONARD DAVYDOV says:

    Could you recommend software that will help me do those IQ, OQ and PQ validations.
    I am self employed consultant that are looking for simple software to do equipment validations for companies.
    Do you have that software and how much it cost?

    • Thank you for your question. If we understand correctly, you are asking about software that will automatically perform IQ/OQ/PQ on instruments. As far as we know, there isn’t such software; at least not for the instrumentation that we most often work with in our targeted industries. There are applications that can be used to electronically execute test scripts (e.g., HP ALM), but you still have to write the scripts and interact with the systems. We are unaware of the cost for these applications as we don’t have/use any of them. However, if script writing is something you’re in need of, that is a Service CSols offers and can help you with. If you are asking about something else, please let us know.

  2. Kareem Khalil says:

    Thanks for sharing this information.
    I would like to ask about the manufacturer software validation (MSV), is it something can replace the PQ?

  3. ES says:

    How does this model apply when cloud based software are considered by the customers?

    • Megan Cavanaugh says:

      Great question. The basic model of IQ/OQ/PQ still applies to hosted and cloud-based systems. As an end-user of any software in a GxP regulated environment, you are required to show evidence that the system is fit for purpose based on your intended use, and regulatory requirements. The difference with cloud-based systems is that Vendors will often “roll out” system updates to all of their customers automatically. Therefore, you need to be aware of that schedule so you can make sure they are doing their functional testing (OQ) for the update, and you can do any necessary requirements testing (PQ).

  4. MariaS says:

    I am having difficulty organizing my PQ test scripts. What perspective should the scripts be written from and how detailed do the test scripts need to be?

    • The primary purpose of PQ test scripts is to verify your user requirements (how the system is expected to work) based on your internal processes and procedures. They should follow a typical end-to-end process or day-in-the-life perspective of using the system. Frequently, PQ test scripts follow SOPs, test methods, or possibly study protocols.

      The level of detail in PQ scripts should be based on how experienced your testers are with the system and the processes. You don’t necessarily need screenshots and evidence for every step in a PQ script, but you do need to produce evidence when it supports a requirement being verified. Also, it’s an excellent approach to write your test scripts so that they can be re-used later; this means don’t “hard code” information in the scripts that could change with each execution (e.g, sample names, locations, etc.). Use pre-requisite sections to identify master data that needs to be set up or configured to execute the steps.

      If CSols can be of help with your PQ scripts or any other part of your validation efforts, please reach out to us here: https://info.csolsinc.com/lets-talk-more-about-validation

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