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European Pharmaceutical Contractor

Integrated Science

Robert Pavlis at Labtronics makes a case for the key types of lab automation products, stating that they are all useful for an efficient lab but an integrated, cohesive system is key for success

There are three key types of lab management products on the market today – LIMS, ELN and SDMS. Suppliers of each of these systems would have you believe that theirs is the most important system for your lab. Traditionally, laboratory information management systems (LIMS) have been the main lab management tool. Some electronic laboratory notebook (ELN) suppliers are now promoting their product as a LIMS replacement and similar claims have been made by scientific data management system (SDMS) developers. What is the correct role of each of these systems and which system do you really need? This article will address these two questions.

AUTOMATION OF THE LAB

The core function of LIMS is to manage samples and test results. LIMS helps to automate the process of tracking samples, assigning tests to samples and recording final results for the tests. LIMS is also a great place to generate final reports, such as a certificate of analysis (C of A). However, what happens after samples are logged into LIMS? How does LIMS help to automate the actual analysis process? The simple answer: it doesn’t.

A LIMS will create a task list of the work that needs to be done. It then sits and waits until results show up, either through electronic means or through manual data entry. While the LIMS is waiting, the lab is preparing standards and reagents, doing sample prep, running analysis, examining raw data and performing calculations. A significant amount of time is then spent on reviewing and approving this work before it is sent to LIMS.

When you examine all of the work that goes on in a lab, a LIMS automates about one-third of the work. If you only use a LIMS, the remaining two-thirds of the work is still manual, and much of it is paper-based. LIMS does not automate the analyst at the work bench.

What is the role of an ELN in the QA/QC lab? It has been designed to eradicate paper and automate manual processes. It has also been designed to work with the analyst at the work bench and control every step in their work.

An ELN is designed around worksheets. Each worksheet is a set of tasks that will be carried out by an analyst. Unlike a LIMS which is sample-centric, the ELN does really not understand the concept of samples and instead is task-centric. When you look at the work being done in a lab, the ELN automates the two-thirds of the work that LIMS does not. It helps the analyst prepare samples, make reagents and carry out the analysis.

When you examine the roles of LIMS and ELN you find that they are very complimentary. The LIMS is used to manage the samples and the ELN is used to carry out the analysis that occurs at the workbench. Each has a very specific role in the lab.

GETTING THE WORK DONE RIGHT

One of the major problems in a lab is that the results depend on the analyst not making a mistake. The analyst is asked to check that the instrument is calibrated and that the reagent being used is the correct one. They have to follow SOPs and make sure there are no errors. They also have to manually record numbers and perform calculations. Therefore, it is no surprise that the process is prone to error. To correct these errors, labs have added a layer of reviewers and approvers. In essence a second person has the job of checking the work done by the first. The job of the reviewer and approver is tedious and repetitive and a lot of errors are usually not caught by this process. A LIMS is not in a position to solve this problem since the LIMS is not involved with the analysis process at the bench level. The ELN, on the other hand, has been specifically designed to solve this problem.

Firstly, ELN removes the paper. Until the paper is replaced with an electronic system you cannot improve the process. Secondly, the ELN performs many of the tasks automatically for the analyst. When the analyst picks an instrument, ELN automatically checks that the right instrument was selected and that it is calibrated. When the analyst scans the bar code on a reagent, the ELN automatically confirms it is the right reagent and that it has not expired. This is an important concept and one of the real benefits of using an ELN. The ELN prevents mistakes from happening by automating much of the analysts’ work.

DATA STORAGE – DO WE NEED ALL THESE SYSTEMS?

Let’s have a look at the data a lab needs to store. Table 1 lists some common types of data found in the lab. LIMS has been designed to store very structured data and is good for storing information about samples as well as test results. This data is stored as fields in a database making it easy to produce final reports. Since it is no easy task to configure the LIMS database, most people store a limited amount of data in the LIMS, focusing mostly on the final results.

 Table 1: Common types of data found in the lab   
 Types of data  Does LIMS manage the data?  Does SDMS manage the data?
 Raw data  No  Yes
 Sample preparation
 information 
 No  Yes, as ELN worksheets
 Metadata for preparation
 of standards
 Not usually  Yes, as ELN worksheets
 Spreadsheets  No  Yes
 Sample information  Yes  Limited
 Test results  Yes  Limited

What about other kinds of data such as spreadsheets and SOPs? As these are documents the database structure used by LIMS is not the best place for storing these items. The SDMS is a specialised document storage system. The SDMS not only stores the documents, but it also provides a simple way to retrieve the information by allowing Google-type searches. The SDMS also provides a workflow manager that can be used to edit and approve documents.

Raw data is normally stored with the instruments that generated it, but this results in data being stored in many locations, hardly efficient when it comes to retrieving your data. Imagine the work required to find all raw data files that deal with a specific sample. How many places would you need to look to get this information? Data collected by the ELN for example, could be stored in the ELN, but that is really not the best place to store it. A well-designed ELN will support commercial SDMS and store all worksheets in the SDMS. By putting all raw data in an SDMS, you have a single place to search and, therefore, retrieval of data is easier.

When most of the data is stored in the SDMS, you can make one query and retrieve all documents for a particular sample. You will get a list of all sample prep information, manual analysis as well as automated analyses. Gathering the facts for an investigation of an issue is now quick and easy.

However, if SDMS stores almost all of the data, do you still need a LIMS? SDMS organises the data in the form of documents – the results for test A might be a document that contains information for five samples, whereas the results for test B are in a different document which contains only one sample. The SDMS does not understand the data and so can not pull out the final approved results. It is great at storing and retrieving the documents, but is a poor choice for reporting final results. LIMS, on the other hand, is sample centric. All of the information is organised for quick reviews of final results and reporting of final data. A LIMS is a much better tool as it makes it easy to review the final results for a sample, or to produce a ‘C of A’ for a sample.

All three systems perform unique functions in the lab but do you need all three? No. People have been getting by with only a LIMS for many years. But then those labs are only partially automated. They don’t have a convenient place to store and find all of the metadata that they should be collecting and their analysts are not automated. Labs waste as much as 10 per cent of their labour force performing unnecessary reviews and approvals. If the goal is to have an efficient, automated lab, you will need all three systems and, more importantly, a way to have them properly integrated into one cohesive system – an iLAB system.

iLAB – THE INTEGRATED LAB

There is now a need to introduce a fourth system, the iLAB, or integrated lab. Figure 1 shows each of the systems in a lab – LIMS, ELN and SDMS, as well as some other minor systems including calibration, training records and chemical inventory systems. The benefit of having multiple systems in the lab is only attained when they are properly integrated. In Figure 1 each application is connected to an integration layer.

It is important that the integration of applications is done in real-time. This means that any information in one system is immediately available to all of the other systems. For example, if the ELN is used to select a reagent, it can immediately retrieve the expiration date from the chemical inventory system, and if it is used to prepare a standard solution, the new standard is automatically added to inventory. When a sample is entered in LIMS, the required worksheets for performing the tests are automatically created in ELN. This integrated system must be designed to use best of breed applications. It needs to be compatible with your current LIMS and the next LIMS you decide to buy. It should be able to work with any commercial SDMS on the market. These applications should be ‘plug and play’ so that they are ready to go – out of the box with minimal configuration.

Above the real-time integration layer is the workflow control section. True workflow control does not yet exist in the lab. That statement may surprise you, but consider this scenario. What happens in the information system when an instrument breaks down at 2:00 PM? Usually nothing. True workflow control means that the system will automatically evaluate everybody’s work schedule and re-prioritise the work. It may stop work on some samples, and move other priority samples to a different machine. All of the manual planning on white boards and all of the running around that is done today would simply be automated by the iLAB system.

SUMMARY

True workflow control depends on first having real-time integration between the applications. The first step is putting LIMS, SDMS and ELN in place and then integrating them so that they function as a single unit. That goal is attainable today, using current iLAB technology.


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Robert Pavlis has an MSc in Biochemistry from the University of Western Ontario and spent eight years as a Sales Manager for Terrochem Laboratories in Canada. In 1986 he started Labtronics Inc to provide software automation solutions for analytical laboratories. Through this company he has been instrumental in bringing many new informatics inventions to the market place. The most significant development by Labtronics was the introduction of LimsLink, the first commercial product to interface instruments to LIMS. Robert has written a number of technical articles in the field of laboratory automation, and has given numerous presentations on the matter.
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