2021 Guide to LIMS Software Validation

Posted by ApolloLIMS on Jan 15, 2021

LIMS Validation

Clinical laboratories are often uncertain about the requirements for validation across the Laboratory Information Management System (LIMS) lifecycle. After your laboratory adopts a new LIMS, you must perform a full LIMS validation prior to using the system for patient specimens. This full validation is necessary to ensure your laboratory’s requirements are met, but it is a labor- and time-intensive endeavor.

A complete LIMS validation is typically not required for routine LIMS upgrades, such as improving performance, releasing new functionality, and fixing bugs. However, to be certain, your CLIA laboratory needs to work with your LIMS partner to fully understand the scope of the upgrade, perform a risk assessment of the proposed changes, and develop a roll-back plan if needed.

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Understand the Scope of the Change

An important first step in evaluating the level of validation activities your laboratory will need to plan and conduct is to encourage your team to review the LIMS release notes in order to fully understand the scope of the change. Most importantly, your LIMS partner should contact your laboratory well in advance of the release to notify you of the planned changes, answer questions your team may have, and give you ample time to prepare. The best LIMS partner will work with your laboratory in advance to inform your team of the scope of the change and its potential impact. Most LIMS changes can be classified generally as major, moderate, and minor. For example:

  •  Major LIMS changes might include user interface changes and/or the addition of new functionality with changes to the underlying database. LIMS vendors typically indicate a major software change by increasing the software version number from 1.0.0 to 2.0.0.
  • Moderate LIMS changes might include the addition of new functionality with no change to the database and/or less significant changes to the user interface. These moderate LIMS changes will result in a change from version 1.0.0 to version 1.1.0.
  • Most minor LIMS changes include only bug fixes and are communicated in a version update from 1.0.0 to 1.0.1.  

Perform a Risk Assessment

Once your laboratory understands the scope of the LIMS change, your team should perform a risk assessment, ideally with your LIMS partner. In the assessment, make sure your team considers the changes to your LIMS in light of the entire workflow. You’ll need to perform validation of any potential impact to your lab’s workflow. Portions of the workflow where no impact is expected will not require validation. Your laboratory may choose to monitor the areas in which no validation is required for a period of time. If your team identifies an area of uncertainty as you assess potential risks, speak with your LIMS partner to evaluate the risk and define validation (or monitoring) requirements. This risk assessment will allow your team to confidently define the scope of the validation that will be necessary for meeting regulatory requirements and preventing issues following deployment of the LIMS update.

In general, it is rare for a LIMS upgrade, even a major upgrade, to result in a full LIMS validation that’s on par with the full-scale validation your laboratory performed when the LIMS was adopted. Often, when functionality is added to a LIMS, it is done so as a module of functionality and code. In this case, your laboratory may be able to perform validation of just the new functionality and any updated interfaces rather than performing a full validation of the entire LIMS system.

Develop a Roll-back Plan

It’s important to note that accepting any scale of upgrade and performing any level of validation comes with risks. One way to mitigate those risks is to develop a roll-back plan. Your LIMS partner should work with your laboratory team to ensure your roll-back plan can be executed quickly in case unanticipated issues arise following the upgrade or validation.

Work with LIMS Experts

To ease uncertainty around LIMS validation processes and requirements, reach out to a team of experts in laboratory diagnostics, like ApolloLIMS. We would be happy to work with your team to optimize how your laboratory operates and ensure its success. Contact us to learn more about the Apollo Alliance.

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Topics: LIMS

Further Reading
LIMS readiness assessment