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Michael Leary

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FDA Compliance

Achieving the LIMS Promise

What application convergence means to the future of laboratory automation

Published: Wednesday, May 26, 2010 - 05:30

In the classic Aesop fable, “The Fox and the Grapes,” a fox desires some grapes hanging high overhead. When he is unable to come up with a way to reach them, he convinces himself that the grapes are probably sour and therefore not desirable anyway. “Sour grapes” has become an idiomatic expression to convey simply the universal human condition of feeling disdain for something that one could not attain.

During the past decade working with life sciences companies, we have seen our fair share of “sour grapes” applied to quality systems and, more specifically, laboratory automation. Although most life sciences and consumer health care companies are in a position to reap significant benefits through process improvements coupled with automation of their laboratories, the cost, resource requirements, and limited flexibility of their systems have remained largely unreachable and therefore, perceived as “sour.”

Our perspective remains that cost reductions, efficiency gains, and increased compliance position should not be so unattainable as to call to mind the unreachable fruit. As life sciences and consumer health care companies embrace the concepts of laboratory automation, they can reap benefits that include:

•Efficiency gains in sample throughput time 

•Reduction in calculation and transcription errors 

•Reduced costs to staff and manage the laboratories 

•Limited reliance on paper and record retention 

•Increased overall compliance position 

•Increased capability to perform data analytics

•Enabled review by exception

In the past several years, changes in quality system technology are driving the convergence of tools and capabilities. Now more than ever, firms are in a position to leverage their existing systems and achieve this vision with significantly less investment.

Unmet expectations

In less than a decade, the industry has shifted significantly regarding spending on compliance and quality system technologies. Gone are the days of “compliance at any cost” as firms experience a significant increase in scrutiny related to technology expenses. Risk-based approaches to solving compliance and quality needs, coupled with an increased focus on return on investment (ROI) and total cost of ownership (TCO), have severely affected funding requests and project support.

Through this new lens, the technology that has undergone the most significant scrutiny is traditional laboratory information management systems (LIMS). Originally a way to capture results and perform calculations, LIMS gained significant momentum during the early part of the last decade due to substantial improvements in their quality assurance (QA) and quality control (QC) workflow functions. In recent years LIMS providers have taken integration to the next level, enabling data capture directly from laboratory instruments.

Although this was a significant step forward for management and control within the laboratories, it came at quite a price. Excessive customization was required, resulting in exorbitantly high implementation and support costs. Further, these systems were often created with management in mind, rather than lab analysts. The functionality needed to automate the laboratory existed within LIMS; however, it was more of a forced fit, prohibiting full utilization within the lab.

In the course of time, both quality and IT leadership began to see traditional LIMS as a costly tool that did not deliver true value for their money. It did little in terms of truly creating opportunities to reduce work, and proved very costly to implement and support.

The appetite for lengthy LIMS implementations, which require significant investments of time, capital, customization, and validation, has virtually disappeared for some segments of the life sciences and consumer health care markets. Additionally, companies have realized the total cost of ownership for traditional LIMS, including maintenance and required support head count, is much higher than anticipated, which has further decreased an already hard-to-justify ROI.

As a result, many companies with stalled or slow-going LIMS implementations are choosing to stop or re-scope their projects short of realizing the benefits that would come from a true laboratory automation solution. The future of laboratory automation is shifting away from traditional LIMS solutions.

The traditional LIMS solution

The original goal for the traditional LIMS solution was to remove paper and achieve compliance gains. Organizations were willing to invest in LIMS with the promise of the following core benefits: sample management, automated calculations, direct capture of instrument results, and reporting.

For several early adopters, LIMS delivered and the success stories spread. At the same time, the focus for LIMS began to shift as organizations realized that LIMS were capable of more than sample management, results capture, and reporting. After the original benefits were realized, many companies began to look at LIMS as a possible solution to some of their other gaps. The goals for many LIMS solutions changed and became more focused on compliance and comprehensive management. The traditional LIMS solution finally took form as a laboratory automation solution—from lot creation to closure with everything in between—that could handle most of the components represented in figure 1.

Figure 1: Traditional LIMS footprint

The compliance and management drivers that led to traditional LIMS remain honorable and relevant. Unfortunately, many of these systems failed to meet organizational expectations, which damaged the LIMS ROI promise. In the pursuit of achieving the right laboratory automation solution, “thick LIMS,” a broad and deeply developed LIMS, was born.

New beginnings… and application convergence

The evolution of thick LIMS has been the result of companies seeking an ideal solution that, quite frankly, did not yet exist. Application providers in the laboratory systems space continued to augment their capabilities to differentiate themselves. This meant that LIMS providers continued to move vertically down into the laboratory instrument integration space and up into batch management. Many organizations followed suit, developing their LIMS systems to fill the voids not effectively addressed by other applications.

Meanwhile, in an effort to be more flexible and adapt to a user base with different requirements, other application providers enhanced their products, blurring the distinction between their functionality and that which could have been done by LIMS. The result has been a convergence of applications in the quality systems laboratory automation space, which can either synergize or replace strained LIMS implementations. Convergence from instrument-centric solutions with electronic lab notebooks (ELNs) and enterprise-centric ones such as systems, applications, and products (SAP) quality management (QM) are squeezing out traditional LIMS.

The convergence of ELN solutions and LIMS has continued to evolve into laboratory execution systems (LES). Just as the movement toward electronic batch records drove development in the manufacturing execution system (MES) space, the movement toward electronic laboratory records has created the opportunity to record data and seamlessly integrate with existing systems and instruments. Many LES systems can now provide functionality previously reserved for LIMS, such as method execution, automated calculations, specification checking, sample tracking, and results review.

Further convergence has been demonstrated by life science companies with significant SAP system investments that are considering deeper utilization of QM and related modules. Beginning with SAP ECC 6.0, the stability management, inspection scenario, and reporting capabilities of SAP’s QM module have been significantly improved. In addition to the improvements in SAP QM, ECC 6.0 is more open and flexible for integration with external systems such as LES, and the platform is SAP’s best yet at allowing for web enablement. This makes possible actions like batch release decisions to be done from a browser window. Add to this scenario the reporting capabilities of SAP Business Intelligence or Business Warehouse, and the quality group will be able to measure, manage, and possibly improve many everyday quality functions through better insights.

As the quality systems landscape continues to advance and converge, it is time to step back and reevaluate laboratory automation solutions. Companies that have long searched for the promised benefits of laboratory automation are now privy to new possibilities. The issue is changing from “if” the benefits can be achieved, to “how” they can best be achieved for an organization.

Figure 2: 10-year application convergence picture

What’s right for you?

Business issues have become more clear, and technology advancements have allowed for alternative methods of sample management, analytical data building, and instrument integration. Traditional LIMS’ original goals are once again in focus; however, this time, there is an opportunity to use best-in-class applications to maximize ROI, minimize TCO, and achieve the ideal solution. The revolutionary landscape for laboratory automation appears to be shifting away from thick LIMS and converging toward “LIMS lite”—i.e., leveraging the strengths of LIMS and other leading applications to create a solution with optimized benefits and lower TCO.

Application convergence has given life to LIMS lite solutions that fit an organization’s needs by combining the strengths of SAP, LES, and LIMS. The exact formula differs among organizations, which must consider the current system’s landscape, company resources, and future strategy that drive the decision-making process. The following is a scenario in which SAP QM, LIMS, and LES work together to automate laboratory functionality and the associated decision-making criteria as compared to thick LIMS.

Key Project Components
• Integration between SAP & lite LIMS, LES
• Full functionality & business process crosses 3 systems
• LIMS lite implementation
• LES implementation for analytical testing & instrument integration


When to Consider
• Current LIMS implementation stalled or slow-going 

• Existing LIMS well established for management, workflow & reporting

• Desire to utilize each system for its strengths


Benefits
• Capitalizes on current LIMS investment
• Each component proven solution in its functional area
• Minimizes customization by focusing on core functionality


Drawbacks
• Project implementation & support costs remain high
• High development/validation/upgrade costs for system interfaces

Figure 3: Scenario 1

In some cases it will prove beneficial to remove the LIMS component entirely from the equation. The functionality that the LIMS solution provides in figure 3 can be replaced by expanding the depth of a SAP QM implementation and extending the functionality of an LES to include more sample management, as shown in figure 4. In this case, LIMS is squeezed out by converging the technologies. This can result in significant cost savings.

Key Project Components
• Integration between ERP QM & LES
• Full functionality & business process crosses 2 systems
• Deep build-out of QM module
• LES for analytical testing, instrument & systems integration

When to Consider
• TCO is driving factor in decision-making.
• ERP implemented at site or planned
• LIMS footprint is outdated or nonexistent

Benefits
• Lowest TCO
• Leverages LES strengths
• Leverages maintenance, support mechanisms for ERP system

Drawbacks
• Most disruptive to system users
• Least "proven" solution

Figure 4: Scenario 2

Figure 5 provides an example of Scenario 2. Unlike the earlier traditional LIMS example (figure 1), all the components are now strategically targeted at the optimal functions. SAP QM handles the lot and sample management functions while allowing an LES solution to focus on activities taking place in the lab. This design allows the scientist to focus on method execution and result entry, while capitalizing on the strong instrument-interfacing capabilities found in the LES to capture instrument results.

Figure 5: An alternative LIMS footprint

New opportunities are emerging in response to life sciences and consumer health care companies’ demands for better efficiency and lower total cost. Technology providers have addressed these issues with expanded functionality packages that are driving application convergence. Companies seeking to optimize their laboratory automation systems must assess their current systems landscape and consider how they can leverage previous investments to build a future strategy road map. As the economy rebounds and organizations look for the next competitive advantage, why not start by revisiting the old quality goals and maybe, finally, turn “sour grapes” into fine wine?

Discuss

About The Author

Michael Leary’s default image

Michael Leary

Michael Leary is a partner with Clarkston Consulting, responsible for developing business and delivering consulting services in Clarkston's North Region. For over a decade, Leary has been involved in leading global initiatives for Life Sciences and Consumer Products companies. These projects include Quality Systems and ERP implementations, organizational design, and regulatory remediation and compliance initiatives. His expertise includes all phases of the life cycle including program and project planning, process design, system construction, change management, and training.

Comments

Good article

Hello,

I'm a manager of system integrater and now in charge of laboratory information system integration.

I've just found your article today. It was amazing that your opinion was the same with us.

I would like to know how do you feel the industry movement after you wrote this.

The industry under regulation moves slower than the other industry such as discrete business.

Thanks,

Tadahiro Kurita

Japan