LIMS Validation Plan


Many companies purchasing a LIMS in a regulated industry realize Computer System Validation (CSV, or, hereafter, “validation”) will be a major consideration. But many are so consumed with requirements gathering, vendor selection, and negotiation they sometimes set aside, if not overlook, the looming validation issues awaiting them.

Of course, large scientific enterprises, long-accustomed to validating systems, apportion a significant part of their project budget to LIMS validation, perhaps ranging between 20% to 35%. The amount allocated depends on basically two things: experience and risk assumption.

What is LIMS Validation?

If you’re operating a lab, compliance with FDA standards is non-negotiable. That’s why LIMS software validation is crucial. It’s the comprehensive process of scrutinizing your computer system to ensure it meets the necessary guidelines. Sure, you could do it manually, but who has the time and resources for that? Automating the process is the way to go.

Interestingly, the FDA states the requirements, but they don’t necessarily prescribe an exact procedure or level of detail to be able to pass their system audits. Companies may need to establish their own approach. If they do it right, they pass, if not, the FDA will let them know.

The Importance of LIMS Validation

If you’re not validating your LIMS, you’re putting your lab at risk.

“Why should I bother validating my computerized LIMS?” you might ask. Don’t assume that LIMS software validation is only for big pharma and clinical labs. Regardless of your lab’s size or focus, proper validation is a must.

It establishes confidence in the LIMS systems, its data integrity, and the results it generates, which are critical for making informed decisions. Proper validation helps identify and mitigate potential risks, ensures compliance with regulatory standards, enhances data security, and increases overall confidence in the LIMS system. It is an essential step in guaranteeing the integrity, traceability, and reproducibility of laboratory data, ultimately leading to reliable and trustworthy outcomes.

When is LIMS validation required?

Simply stated, many products intended for therapeutic use or diagnoses for which LIMS are used to determine product quality are in the target range. Pharmaceuticals, biologics, anything having to do with blood and blood components, human tissues and cells, and infant formulas are fair game.

While LIMS validation is commonly believed to be a United States FDA-mandated practice, it is sometimes not understood that countries outside of the United States, hoping to market products within the U.S. are also required to validate their systems. In fact, there is an informal cooperation between the U.S. FDA and its Chinese counterpart, the Chinese FDA (or, CFDA) to ensure system conformance.

What is Included in LIMS Validation?

There are many aspects to a LIMS validation. Just as in system selection and planning, detailed system requirements are critical because companies are expected to demonstrate the requirements they initially documented have carried through to system design and operation. This is a simplistic yet accurate explanation of the process at the highest level.

Though there are many constituents of the process, but for brevity, the commonly articulated items are Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

IQ is typically provided (or augmented) by the vendor. The IQ basically verifies the product was installed as it was intended. OQ verifies that the system performs as expected in the user environment. Many LIMS vendors sell “validation packages” which usually consist of template scripts for OQ work. In many cases, these are well worth the money as they can save hundreds of hours of writing. PQ involves rigorous testing of the system with prescribed scripts, and meticulous documentation of the results of each and every test.

A few last words about validation. First, we have not delved into the field of medical devices mentioned above. There are additional requirements for these, not the least of which is a 510(k) technical dossier. Furthermore, companies who are coming from electronic systems or previous LIMS that wish to “import data” from the legacy systems should know that interfaces that push data into systems affecting product quality are themselves required to be validated.

Last, there are a great many validation experts who live and breathe LIMS validation. They are easy to find and may save a company a lot of money in the end. After all, failing an audit causes all sorts of actions to kick into gear, and they cost time, money, and perhaps, reputation.

At CloudLIMS, we’re more than just a lab sample management software provider. We’re committed to providing you with the best-in-class, cloud-based Laboratory Information Management System (LIMS), combined with a deep understanding of your compliance needs. And with our computer system validation plan, you can take control of the process and enjoy the importance of LIMS validation that comes with it.