yield the best product. As part of a paperless lab environment, an SDMS integrated with the LIMS reduces paperwork, manual review time, and data transcription, which improves efficiency, productivity, consistency, and quality while reducing costs dramatically. SDMS also provides secure access to archived files for as long as necessary, and enables more efficient and defensible reporting to regulatory authorities.
Laboratory Information Management Systems LIMS remains a critical part of the infrastructure of any pharmaceuti-
cal manufacturing organization. Today’s LIMS goes 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 trend- ing 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.
Having a smart infrastructure built on a state-of-the-art informatics solu- tion at its core enables another critical benefit in the lab: automation. Even smart instruments must undergo regular performance verification. How often this is done depends on many factors, including the frequency of use. Because instrument failure—or having a system go out of specifica- tion—can negatively impact quality, production, or compliance down the road, any risk is unacceptable. A LIMS can save considerable time by helping labs adhere to precise rules and requirements, automating critical procedures on predefined schedules.
When all systems are aligned, the convergence of people, processes, and technology is transformative. Problems arise when these systems are not fully integrated, and these disparate systems become out of sync. At a macro level, breakdowns occur at three key points: data capture, data transcription, and data management. Put another way, the key to an efficient lab that delivers uncompromising quality is having smart instruments within a smart infrastructure. This starts with SOPs for highly standardized methods and processes, which are handled by the LES, and includes raw instrument data generated by the analytical instruments used in those experiments, all of which are handled capably by the SDMS.
What lab managers really want is a truly connected system that provides lab management, drives lab operations, and integrates all of the data- generating sources and ties all the data together in one centralized loca- tion. A modern LIMS needs to be a complete informatics infrastructure by providing a LIMS, SDMS, and LES in one.
Achieving much-anticipated integration Today’s paperless lab can more aptly be called an integrated lab. The trin-
ity of LIMS/LES/SDMS enables lab managers to achieve full instrument integration, manage their methods and workflows, retrieve and archive any kind of raw laboratory data, and export those results across the orga- nization to enterprise resource planning (ERP) systems, for example, all in whatever format is required by recipients.
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, imple- mentation, validation, and ongoing maintenance. An example of this is SampleManager LIMS (Thermo Fisher Scientific), which includes built-in functionality for LIMS, LES, and SDMS as well as integration technologies. What’s more, when labs plan for such seamless integration it enables lab managers to codify a “do it right every time” process approach, which is in alignment with QbD processes, providing the transparency necessary to identify and remove nonvalue-add steps, while lowering the cost of training new staff. With LES functionality available as part of a LIMS implementation, SOPs and methods are automatically established elec- tronically so that for any lab personnel, new or seasoned, the LIMS acts as their workflow, manual, and constant guide.
It is easy to see the LIMS, LES, and SDMS “stack” as a lab-centric view of pharmaceutical business, but that would be a mistake. The ability to run efficient labs and protect the brand by safeguarding product quality is an enterprise-level concern. As such, the LIMS needs to be fully integrated with ERP systems; in fact, many work requests coming into QA/QC labora- tories are actually initiated in a manufacturer’s ERP system, which for many companies is the bridge between its manufacturing execution system (MES) and other systems such as the LIMS.
Conclusion In many organizations, a LIMS is a standalone investment, managing workflow and sample testing and generating appropriate reports. If the lab needs additional software, such as an electronic laboratory notebook (ELN) or SDMS, those systems are then implemented and sometimes, but not always, integrated with the LIMS so that lab operations are more streamlined and data are easier to manage. In a QA/QC lab, however, a LIMS such as SampleManager, that is prebuilt with LES and SDMS func- tionality and delivers end-to-end workflow and data capture, is literally designed for quality. The benefits of having all these capabilities resident in a single system are myriad, starting with lower total cost of ownership, ease of training and administration, streamlined compliance, and better overall quality control. All of this is possible across vast geographies or contractual partnerships, and can all be managed holistically.
Organizations that have not done so already need to make this year a major inflection point for laboratory technology, especially within the QA/ QC function. After all, the evidence is stacking up that the costs of inaction clearly outweigh the investment that is required for change.
References 1.
https://www.gartner.com/doc/2597215/product-innovation-requires- laboratory-informatics
2.
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3933B1_02_ Pharmaceutical%20cGMPs.pdf
Trish Meek is Director of Product Strategy, Thermo Fisher Scientific, 1601 Cherry St., Philadelphia, PA 19102, U.S.A.; tel.: 215-964-6020; e-mail: trish.
meek@thermofisher.com;
www.thermofisher.com
AMERICAN LABORATORY • 31 • JUNE/JULY 2014
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