Smart Infrastructure is Key for QA/QC

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Courtesy of Poplar Solutions, LLC

Paperless, or more accurately integrated, labs enjoy streamlined operations with better data, while minimizing costs, validation and maintenance.

Laboratories responsible for QA/QC are a sum of many parts, but no part is more important than data. Data is THE product, and the integrity of that data is more than critical to today’s pharmaceutical laboratories. So what happens when processes on which labs rely on to generate data break down? Inaccurate or inefficiently collected results can become common, resulting in product release delays or even product recalls. This leads to time-consuming rework, reduced productivity and lost revenue. This may seem like a thing of the past, but today’s laboratories are often more oriented around yesterday than today, given the amount of manual or paper-based processes that still dominate even in the most sophisticated of environments.

Walking around a modern laboratory, it is always impressive to see how far laboratory technology has come. Advancements in ubiquitous techniques like chromatography and mass spectroscopy have impacted almost every industry and application—companies have changed dramatically this past decade to fulfill a mission to make the world a healthier, cleaner and safer place. However, in these modern laboratories, you can still find scientists next to an instrument, copying the results from the instrument data system into a paper notebook. Why, when we spend so much effort to ensure that we execute the best scientific process and use the most advanced equipment to create our scientific data, do we treat the data so archaically? Cutting and pasting within Excel or manually entering data into a PC that’s not connected to the instrument is as yesterday as it gets.

Industry analyst Michael Shanler from Gartner highlights this trend in his report, “Product Innovation Requires Laboratory Informatics Systems to Transcend Phases.” He observes that today’s laboratories “are, for the most part, disconnected.” As such, he recommends that manufacturers “prioritize end-to-end informatics investments and align metrics for innovation, domain expertise, operational efficiencies and quality.”

It is easy to think of the lab as a self-contained island and to measure its success by its efficiency. The reality is that in a manufacturing or QA/QC environment, the lab is actually judged by the value it provides to the business as a whole. To that end, labs must adopt a smart informatics infrastructure that drives the flow of information, not only in the lab, but throughout the organization. An integrated informatics solution can turn a laboratory into an engine that goes beyond ensuring product quality and delivering business transformation and a culture of continual process improvement.

The key to an efficient lab that provides reliable data is simple: integrating many smart instruments and systems within a smart infrastructure. Today, that smart infrastructure exists within a proven enterprise-level laboratory information management system (LIMS), where many instruments—from the benchtop balance to chromatography and spectroscopy data systems—are tightly integrated. The smart lab is made smarter when that LIMS is built with embedded method execution capabilities (Lab Execution System [LES]) so that workflow is predetermined and productivity from processes, as well as accuracy of results, is guaranteed. A smart LIMS will also have the ability to manage raw instrument data (often done separately with a scientific data management system or SDMS), so that archiving, retrieving and viewing instrument data is automated. This greatly enhances the ability to meet any regulatory audit requirements or do customer reporting while dramatically improving efficiencies in the lab. And, finally, this smart infrastructure becomes even more valuable to the organization when the LIMS is fully integrated with existing enterprise systems, such as ERP, MES or PIMS, so that management at any level has access to data being generated in the lab. Once an organization achieves this, the lab can become truly paperless, where automation reduces transcription errors and saves time, and lab data is accessible enterprise-wide in real-time. In this environment, data is reliably collected, managed and applied to the business for maximum benefit.

Today’s LIMS can go far beyond just the management of samples, tests and results. It also provides resource management, allowing organizations to forecast fewer sample volume and resource needs. It provides dashboard views that allow organizations to see how their lab is operating and identify any data that are trending toward warning or failure limits. These lab management activities are essential, but organizations need to be able to drive the day-to-day operations of the laboratory as well. Some LIMS go beyond lab management and also provide simplified user interfaces that step technicians through the execution of a lab method or process from start to finish, integrating not only the final result, but also the actual scientific data and any ancillary information associated with the sample.

Many laboratories are looking to become “paperless labs,” but perhaps it is more apt to call them an integrated lab. The ability to manage the entire process in a tightly integrated solution, one that functions as a single piece of software, dramatically streamlines laboratory operations while minimizing the cost of ownership, implementation, validation and ongoing maintenance.

The paperless lab is a hyper-efficient environment where data from any instrument can be collected and analyzed holistically. Optimizing data collection is critical and a first step in ensuring that each endpoint is effectively contributing to QA/QC integrity.

Data collection
With instrument performance, there are two main questions: do I have the right system for my application, and is my instrument performing optimally?

Even a smart instrument must undergo regular performance verification to ensure that it continues to operate within specifications. How often this is done depends on the risk a lab is willing to accept—in other words, how much data would be in jeopardy if the instrument fails or goes out of specification between testing intervals and what impact would this have on business? Regular maintenance schedules for all instruments can be pre-set in the smart LIMS so that no project or test is ever in jeopardy of failure due to diminished instrument performance.

In addition to performance verification, system suitability testing ensures that instruments are capable of providing accurate and reproducible data for a specific application. This is often assessed during method validation and again before each batch of samples is run.

Finally, many accessories require calibration or alignment for optimal performance. This is another area where having a LIMS is critical, saving time by helping labs adhere to specifications by automating critical procedures on pre-defined schedules, which also helps ensure compliance with industry standards such as ISO 17025. And for further ease, processes defined for one instrument can be applied to other instruments in a few simple steps. Spectroscopy, chromatography and mass spectrometry systems, alongside many other instruments and equipment in a typical pharmaceutical lab, integrate seamlessly with a LIMS to continually optimize instrument performance, ensuring uninterrupted workflow and integrity of test results.

Information management
It’s not unusual for today’s pharmaceutical companies to struggle with increasing workloads, reduced personnel and increasingly diverse customer requirements. This means that labs are generating even more data, making manual data management even more unrealistic. Once automated, however, all this data can actually be put to work more effectively. Automatically integrating all this data, even different data types, accelerates the process and significantly reduces errors—in a paperless lab the well-known pitfalls of human transcription are gone.

From the loading bay, where raw materials arrive and are scanned with a handheld analyzer to ensure conformance to specifications defined by the company ERP system, to final shipment of finished product, removing the potential for error and misinterpretation is critical. Today, labs can accomplish this with strict adherence to standardized methods, automation and software-enabled analysis. User training and monitoring are, of course, also an absolute necessity. By automating this holistic data management process with LIMS, labs mitigate the time and expense of user error and give personnel time back to actually analyze data for better decision-making.

The smart infrastructure for pharmaceutical labs—a proven combination of LIMS, SDMS and LED—is a software-enabled safety net that ensures lab-wide reliability across multiple labs, buildings or geographies. And, most importantly, the final product of the lab—its data—is securely accessible throughout the enterprise and beyond via desktop, web and mobile platforms. It’s always good to take a fresh look at your laboratory and identify rate-limiting steps. Are researchers still writing in notebooks? Is Excel open in the lab or offices to perform calculations? Is information manually transferred between systems?

Organizations that take a fresh look often discover opportunities for transformation. They, in fact, lay the groundwork for major laboratory technology advancement, especially within the QA/QC function. It does require different thinking to embrace meaningful change, but the question isn’t whether you can afford to think differently about your data, it’s can you afford not to?

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