Change Happens: Documenting Your Evolving LIMS

By Chris Casper

Laboratories never stand still. They constantly adapt to internal and external forces of change. Lab managers must anticipate and plan for organizational change to guide their labs’ long-term growth. Equally important but not as appreciated are the changes that regularly happen on much smaller scales.

Rounding Out Your LIMS with LabLynx Services discussed the change control services LabLynx clients may use to document changes in their laboratory information management system (LIMS) software. This blog post will review all the ways your LabLynx ELab LIMS can track changes in your lab.

Modifying test procedures

How laboratories conduct their tests can change daily within the scope of established methods. Over more extended periods, those laboratory methods can also evolve. In either case, a LIMS plays a vital role in documenting modifications to test procedures.

Analysts adjust sample sizes, reagent quantities, temperatures, and other variables from project to project. They make these adjustments within limits set by the test’s standard operating procedure (SOP). Your LIMS includes these values in permanent records of the testing process. Should you need to investigate anomalous results, query tools let you measure the contribution of test execution.

Eventually, your laboratory’s test methods may change. Perhaps more effective reagents allow faster sample preparation procedures. Or standards organizations like ASTM update their methods based on the latest research. Your staff can easily reconfigure methods and workflows in your LIMS to modify the test procedures. The system will save these changes with unique version numbers. Your LIMS will associate records for all subsequent tests with the new versions.

Good laboratory practice requires thorough SOP documentation of routine testing activities. You will build many of these procedures into the method configurations of your LIMS, ensuring proper and consistent execution. Other procedures happen outside the LIMS software, so making SOPs accessible can help laboratory staff follow approved procedures. You can keep electronic versions of your SOPs in your LIMS so anyone can access the most current versions.

What’s more, the file management system in your LIMS goes beyond SOP storage and retrieval. Your LIMS saves each update to an SOP with a new version number, letting you track the history of your lab’s documentation. This ability to instantly retrieve a current SOP and its previous iterations is particularly helpful during ISO/IEC 17025 audits.

Evolving technology

Whether or not you’re all-in on Lab 4.0, there’s no denying that laboratory technology is getting more connected. Robotic systems automate routine operations to accelerate throughput and free up technicians for higher-level work. Networked instruments eliminate thumb drives for data transfers. Sensors and other industrial Internet of Things technologies deliver more information about, and control over, your lab.

However, technology’s growing role creates new challenges. An instrument’s firmware updates may trigger new validation cycles that disrupt daily operations. Maintenance of high-tech equipment is more complex. To cap it off, labs must track any changes in this equipment to meet regulatory and other compliance requirements.

LabLynx ELab LIMS integration services simplify technology management. The metadata associated with each instrument lets you track firmware and software updates. Monitoring instrument performance and utilization rates makes scheduling calibration, maintenance, and validation events easier.

Replacing laboratory consumables

A LabLynx ELab LIMS solution can include inventory management capabilities. Your LIMS will track reagents, culture media, and other consumables. Knowing test by test how much your lab consumes makes it easier for your lab’s administrators to keep supplies stocked while minimizing inventory costs.

Besides inventory quantities, a LIMS’ inventory management system will record the source, catalog ID, batch number, arrival date, and other metadata for each item entering your lab’s inventory.

Having this information in your LIMS can improve laboratory safety. Your LIMS can track the age of each consumable and flag items for disposal after their expiration date. In addition, your LIMS can combine inventory information with data from environmental sensors or refrigerated storage systems. If any supplies become exposed to out-of-spec temperatures, the LIMS can generate alerts to prevent the spoiled supplies from impacting test results.

Inventory metadata in your LIMS can also generate insights into your lab’s testing performance. For example, you can evaluate the performance of a new supplier’s products. Querying your LIMS for test results using the new and old products lets you make quick side-by-side comparisons.

Consider the scenario of molecular diagnostic labs during the COVID-19 pandemic. Soaring demand for reagents and supply chain disruptions sent labs scrambling to find alternative suppliers. With thousands of swabs arriving every day, there was little time to conduct full due diligence. Querying results and metadata in the LIMS could show whether the new reagents caused variances in their testing.

Updating LIMS code

You can also use your LabLynx ELab LIMS to track changes to the LIMS itself. We touched on this when discussing modifications to your lab’s methods and workflows, but LIMS change control goes beyond feature configurability.

Other aspects of LIMS change management happen behind the scenes. Our developers keep detailed records of every change to our cloud informatics platform’s code. These change logs are available through LabLynx change control services for clients in highly regulated industries.

Clients who ask for customizations of our LIMS software often use our change control services. These customizations create new capabilities uniquely tailored to the client’s operations. Any client requests go through a formal scoping, approval, development, testing, and documentation process. Clients may receive the detailed records to fulfill their internal change control requirements.

Take control of change in your laboratory

Properly harnessed, change can become your lab’s competitive advantage. Use your LIMS to eliminate disruptions, embrace technologies, and improve compliance. In turn, your staff will have more time for more productive work while increasing your lab’s testing capacity.

Read Rounding Out Your LIMS with LabLynx Services to learn about other ways LabLynx enhances our LIMS solutions. To see how a LabLynx LIMS can transform your lab, contact LabLynx’s change management experts.

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