LIMS Validation: What is IQ, OQ, PQ?

admin — Wed, 12 Jan 2022 09:09:47 +0000

Laboratory Information Management Systems (LIMS) are becoming an integral part of laboratories. While all LIMS are used primarily to improve laboratory productivity, efficiency, and compliance. It is important that the systems are properly validated and correct. Errors can occur in terms of tracking data associated with samples or tests, or acceptance/refusal criteria can be assigned to the wrong sample, causing varying degrees of inconvenience to the laboratory. To avoid these errors, a LIMS can be validated through a process called the 3Q approach for “IQ, OQ, PQ“. Discover now what it means.

The 3Q approach

Validation of software before its use is essential to guarantee the quality of data processing. In the context of software, the 3Q approach is followed in the process of validation.

Overall, the goal of performing IQ, OQ and PQ is to ensure that the software can be implemented successfully and that all functionalities can be used without any problems.

These 3 steps should generally be done in order. Once the installation is complete, the functionality can be tested, and the performance measured.

The 3Q approach: IQ, OQ, PQ

Installation Qualification (IQ)

Installation Qualification (IQ) is the validation process to verify that the supplied software can be successfully installed on the specified environment, with the specified configurations.

Operational Qualification (OQ)

Operational Qualification (OQ) includes all the tests to be performed in order to verify that the software is operationally ready to be deployed to customers. The key functionalities of the software are verified in this validation process. The team of testers is in charge of this step and all the tests performed and the results must be provided in a document for the customer.

Performance Qualification (PQ)

This key step is the Performance Qualification (PQ) to ensure that the software, when installed on the final system, can handle the real load, respect the expected response time and does not fail in case of high demand or spike in use when connecting users simultaneously.

Validate a LIMS for better performance!

The success of the IQ-OQ-PQ validation process is a very important step for all the actors. It not only gives confidence in the software, but also gives peace of mind to the customer and the vendor’s team. This validation makes it possible to meet the compliance requirements set by the FDA (FDA 21 CFR Part 11) or ISO.

Performing IQ-OQ-PQ also reduces the risk of a live deployment and eliminates failure.

LabCollector’s teams help you from start to finish! If you need to validate the system to meet the demands of certification bodies, we will perform the IQ, OQ, PQ process for you. Don’t hesitate to contact us for more information.

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