Vendor Column: Reducing System Complexity by Standardizing Laboratory Informatics Solutions

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  • Published: Nov 17, 2011
  • Author: Chris Stumpf
  • Channels: Laboratory Informatics / Chemometrics & Informatics
thumbnail image: Vendor Column: Reducing System Complexity by Standardizing Laboratory Informatics Solutions

Welcome to the first in a series of features from Chris Stumpf, a marketing manager at Waters Corporation who focuses on Lab Informatics. Every two months, Chris will publish a new informatics-related article which we hope will build into a worthwhile compendium of informatics material. This month, Chris looks at how a wealth of new standardized informatics solutions are helping the scientist to reduce the drudgery of manual data management in the lab. 


A company's brand represents an experience and a level of quality to customers. In order to provide a repeatable experience and satisfactory level of quality, organizations implement quality systems - a set of common sense procedures and processes that ensure a product is manufactured reliably with a reproducible level of quality. Documentation (standard operating procedures, testing specifications, etc.) and quality testing data play a vital role in a quality system.

As computer automation has become more capable and pervasive, organizations rely more heavily on computer based systems for standard laboratory quality testing operations in support of the overall quality system. Adoption of informatics platforms often happens at the local laboratory level resulting in the use of Chromatography Data Systems (CDS), Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN), and Scientific Data Management Systems (SDMS) systems from a variety of vendors across the organization. Although these solutions were originally selected to simplify workflows in a particular laboratory, they gradually began to fill a broader role within the organization. To address the more comprehensive needs of a quality system, these bottom up conceived systems became more-and-more integrated with other informatics platforms, increasing the complexity of system-to-system integration and validation sometimes to the limits of comprehension. Eventually, however, a cultural changing event occurs such as a merger-or-acquisition, a warning letter from a regulatory agency, or a decision from executive management to improve profitability. Once the barrier to change has been crossed, how does one go about designing an overall laboratory informatics system that reduces the complexity of the quality system?

After overcoming the cultural barrier to change, organizations have begun to take a systems approach to the laboratory informatics architecture. One conceptualization model being adopted for laboratory informatics architecture is the ANSI/ISA-95 standard-- ANSI/ISA-95 organizes abstracted hierarchal layers between the enterprise planning and the plant production process. A typical structure would include six levels, as is shown in Figure 1 below.

Figiure 1

Figure 1. A typical ANSI/ISA-95 model organizes abstracted hierarchal layers between the enterprise planning and the plant production process.

Starting from the outlined 6-tier abstraction, the model is adapted for laboratory informatics and focuses on Levels 1-4 (the laboratory data flow) to consist of a 4-tier abstraction:

Level 4: ERP and batch release
Level 3: Laboratory workflows and batch testing (CDS, SDMS, ELN, LIMS)
Level 1&2: Laboratory equipment and process monitoring (LC, LC/MS, balances)

Within Level 3, further refinement of the system design takes place such that the CDS and SDMS manage data from the laboratory instruments while the ELN and LIMS sit between the CDS & SDMS layer and the ERP (Enterprise Resource Planning) layer (see Figure 2). The ERP solution is commonly integrated with the laboratory systems, but scientists and analysts typically do not log directly into it. Instead, the ELN is increasingly playing a unique role because it is acting as the system that connects the systems together (ERP to CDS) into one coherent solution (from the scientist's or analyst's perspective) and is sometimes referred to as a laboratory execution system because of this capacity.

Level 3c: LIMS - sample management, test scheduling, etc.
Level 3b: ELN - acting as a notebook or laboratory execution system
Level 3a: CDS (controls and manages data from SFC, LC/UV, LC/MS, CE)
and SDMS (manages data from non-chromatography systems)

 

Figure 2

Figure 2. The ANSI/ISA-95 model is adapted for laboratory informatics and focuses on Levels 1-4. Within Level 3 the CDS and SDMS manage data from the laboratory instruments while the ELN and LIMS sit between the CDS & SDMS layer and the ERP layer.

Once the abstraction model is in place, the process of informatics system consolidation often begins and this is usually the point where scientists and analysts become involved in the project. The benefits of laboratory informatics system consolidation to the organization as whole includes a more robust quality system, a system that is easier to maintain and integrate by IT and a system that facilitates regulatory compliance. But what benefits do the scientists and analysts receive from a simplified system? Quite simply they can spend more time on science and less time on mundane operations such as manually backing up data, transcribing and re-transcribing text, performing manual calculations and learning the idiosyncrasies of multiple laboratory informatics solutions.

What can you do, if you become involved in a laboratory informatics consolidation project within your organization? In most cases, the first step involves creating a user requirements document that defines each function you need the informatics solution to perform. This user requirements document will also be useful during the system validation phase after implementation. In addition to satisfying laboratory workflow requirements, you will want to confirm that the systems are compliant-ready (provides software controls such as audit trails to adhere to regulatory compliance requirements); scalable, so that as your organization grows, the system can grow; deployable over a wide area network (WAN), so that geographically separated units of the organization can connect into the system; and provide an application programming interface (API), so that different informatics systems can be integrated for efficient data flow, e.g., connecting the CDS to the LIMS. And probably the most important item to keep in mind is not a product feature but the vendor's enterprise service capabilities. You will need the vendor to design the system, deploy it, help with integration, and validation. And if your organization is multi-national, the vendor will also need to provide a world-wide support model. Although this is not an exhaustive list, it does provide you with the key steps before you begin the vendor selection process.

In summary, the competitive landscape is driving organizations to standardize the laboratory informatics environment such that the overall quality system becomes simpler to maintain, validate and operate. Often scientists and analysts find themselves involved in laboratory informatics standardization programs without visibility to how the architecture simplification benefits the organization while also making their lives easier. However, the dramatic improvement in informatics solutions within the past 5-10 years offers a tremendous opportunity to reduce the drudgery of manual data management, manual calculations, and repeat text transcription. As a result, scientists and analysts stand to benefit the most from standardized laboratory informatics systems.

 

Article by Chris Stumpf, Waters Corporation



The views represented in this article are solely those of the author and do not necessarily represent those of John Wiley and Sons, Ltd.

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