Getting Lab Data Closer to the Decision Point Keeps Product Release on Track

Since 2022, FDA has issued more than 600 warning letters for violations of GxP requirements (1). Regardless of the origin—poor documentation, incorrect data collection, or incomplete training—the cost of a warning letter for non-compliance can derail a manufacturing operation.

In the lab, leaders are laser-focused on maintaining compliance. With existing complex system infrastructures and heavy reliance on manual test execution, the manufacturing lab has an opportunity to streamline operations for reduced risk and increased efficiency. Positive change is underway as the industry moves to improve lab processes and enable more connected, seamless, and automated ways of working.

Three pillars that can increase lab efficiency include bringing test execution and sample management data onto a single digital platform, improving right-first-time by having procedure documents and execution in the same system, and enabling review by exception. These advancements can drive productivity while making lab data available much faster, improvements that can keep product release on track.

Bringing together test execution and sample management is possible

Using one system to execute tests and manage sample workflows is possible. However, the typical quality control (QC) lab infrastructure, which is complex and siloed, is a significant barrier to change. Many are working to shift the data captured during QC processes from paper to modern digital tools.

To execute tests digitally, organizations are turning to electronic lab notebooks (ELN) and adding them to existing laboratory information management systems (LIMS). The approach helps lab staff move from capturing test data manually to an electronic application, but it doesn’t address the problem to the core. Staff will have to work through two separate systems for test execution and sample management, increasing the risk that data are incorrectly entered or lost throughout the process. This approach also requires repetitive work across different tools to review, load, and distribute the latest approved procedures.

When evaluating how to improve QC lab processes, one must consider the downside of bringing an ELN to existing infrastructure. ELNs are typically difficult to configure, take a long time to implement, and can require significant resources, especially since many aren’t good manufacturing practice (GMP) compliant and require additional validation.

A LIMS can enable lab staff with test execution and sample management in one solution. Analysts can pull up the latest approved processes, capture test data, and complete sample workflows while referencing procedure documents in a single system.

Using one application to manage key processes simplifies the workflow for staff and removes the need to manage multiple tools and logins. Accessing information and executing critical processes within the LIMS can be a game changer for lab productivity and efficiency.

These efforts can deliver significant benefits beyond the lab. Adopting a LIMS with open APIs makes connecting data across the enterprise easier, bringing together quality assurance (QA) and QC data and content with the company’s manufacturing execution system (MES) or enterprise resource planning (ERP) systems. The increased transparency can help identify risk areas and allow teams to take proactive action to ensure product release remains on track.

Ensuring right-first-time takes science and execution

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 because 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.

Enabling speed and efficiency with review by exception

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.

Determining the best path forward to accelerate product release

An advanced LIMS system can digitize processes, improve right first time, and speed up exception reviews so that products can be shipped to market faster. Evaluating LIMS thoroughly and carefully for current capabilities and scalability is vital. One must keep an open mind during the evaluation phase if a system does not have all these capabilities in one package. This can drive unexpected collaboration with providers to address long-standing industry challenges.

Manufacturing labs have required turnaround times to complete rework from exceptions or failed procedures, and an advanced LIMS can alleviate this pressure while significantly impacting effectiveness and speed. A solution that unifies QA and QC can reduce overall turnaround times and shorten review cycles, getting companies closer to real-time batch release.

If a company has a legacy LIMS, it must evaluate whether it is worth keeping that system within a fragmented technology landscape. To make meaningful advancements in right first time, review by exception, and batch release, the company should consider moving forward with a solution that can execute these processes in a single system. It could enable end-to-end execution, real-time access to procedures, and easy employee qualification. With a single system, batch information can be reviewed, analyzed, and released faster to get them quickly into the hands of doctors and patients.

Reference

1. FDA. Warning Letters (from 2022-2024), 2024. FDA.gov (accessed July 19, 2024).

About the author

Jason Boyd is senior director, Vault LIMS, Veeva. Jason has more than 20 years of experience with laboratory enterprise solutions. He can be reached at jason.boyd@veeva.com.