Keep your lab data close to your product release decision points

In the United States, the US Food and Drug Administration has issued more than 600 warning letters for GxP (good practice) violations since 2022, often due to poor documentation, incorrect data collection, or incomplete training.

Non-compliance can disrupt manufacturing operations, making it critical for labs to maintain compliance. However, the complexity of existing infrastructures and reliance on manual processes present opportunities to streamline operations, reduce risk, and improve efficiency.

As the industry embraces more connected, automated ways of working, labs can focus on three key areas to improve efficiency: unifying test execution and sample management, improving right-first-time procedures, and enabling review by exception. These advancements can boost productivity and help ensure products are released on time.

Unifying test and sample processes

Many labs rely on disconnected systems to execute tests and manage samples, leading to inefficiencies and errors. While electronic lab notebooks (ELNs) are commonly used alongside laboratory information management systems (LIMS), this approach often requires working through two separate platforms, increasing the risk of data entry mistakes and redundant tasks.

A LIMS offers a solution by unifying test execution and sample management in one system. This

allows lab staff to access approved procedures, capture test data, and manage workflows within a single platform. By eliminating the need for multiple tools and logins, labs can simplify workflows, improve accuracy, and enhance productivity.

A LIMS with open APIs can further extend these benefits across the enterprise, connecting quality assurance (QA) and quality control (QC) data with other systems, such as a company’s MES or ERP. This increased transparency helps identify risks earlier and ensures product release remains on track. 

‘Right first time’ takes science

If a company can maximize right first time, it can drive speed, effectiveness, and cost savings. The metric is a leading key performance indicator (KPI), and the industry is evaluating options to improve it while providing a seamless experience for staff.

Right first time focuses on ensuring the lab has the proper, approved, compliant procedure to test a product and capturing the outcomes in an execution system. Because of the increased risk of executing these processes on paper, companies are adding standalone tools that offer a modern guided experience for users. This might simplify the specific process but increases the complexity of the lab, adding yet another system and login that users will need to learn and manage. If lab staff accesses a system and works off the wrong process, it creates another workflow to correct the error that can impact manufacturing and batch release times downstream.

Some might consider an ELN to address this challenge, establishing a plan to copy text from one system into another. By duplicating the document and manually configuring the process into an ELN, companies are increasing the cost of ownership and overall risks. An ELN drives consistency in the instruments used, ensuring consumables aren’t past their effective date, but is the trade-off in cost and compliance worth it?

Even the best-laid plans can lead to expensive, less-than-expected results. Developing and maintaining test methods takes time, and costs add up quickly. Realistically, using an ELN and replicating or developing procedures likely isn’t a viable alternative for most companies who want to improve right first time.

Using a LIMS that unifies QA and QC provides a single system to access a procedure and record results and observations. This allows procedural documents to always be up to date and qualified since the latest document is available for access in the lab as soon as an approval workflow is completed. The approach doesn’t require reproducing test methods, which can lower costs and save time and effort.

A LIMS with QA and QC data can block unqualified users from conducting a test they aren’t trained to do. This can save the trouble of the completed test being found invalid, requiring a new test to be performed. If the system can also allow for instrument selection and effective date filters, LIMS could deliver a one-stop-shop solution for most critical lab needs.

Fast and efficient

Lab data review has traditionally been an exhaustive and tedious process. The industry is looking toward technology to complete as much data review as possible without increasing risks. With all the tests conducted, labs have vast amounts of data to sift through and investigate where deviations occurred. The implications for the business are costly, and finding a solution for exception review is an industry-wide priority. 

Data collection happens daily, but deviations are rare and not always obvious. With the disconnected lab landscape, exception review happens across instrument systems, LIMS, ELNs, MES, and paper documents. Companies can’t ship their product until a qualified person completes the review. Many have audit trail reviews to look for exceptions not reported by the operator, but it isn’t enough to streamline the process. 

A LIMS with exception, detection, and identification can help address some of the time required to conduct data reviews. By using a system that can manage end-to-end review by exception while automating processes, companies can save significant effort and shift the focus to high-value activities.

Accelerating product release

An advanced LIMS can significantly improve lab efficiency by unifying test execution and sample management, enhancing right-first-time performance, and enabling review by exception. Labs that adopt such systems can digitize processes, reduce errors, and speed up product release timelines.

When evaluating whether to invest in a LIMS, consider its scalability and ability to integrate with other enterprise systems. If your lab is working with a fragmented technology landscape, transitioning to a unified solution could lead to substantial improvements in productivity, compliance, and product release speed.

Jason Boyd is senior director, Veeva Vault LIMS

References: 

1. FDA, Warning Letters (from 2022-2024), 2024