Developments & Trends in LIMS – A ‘Coming of Age’?
Stefano Marocco, Account Manager &
Elian Winstanley, Managing Director
at STARLIMS, UK
Over the last 10 years, laboratory information management systems (LIMS) have changed beyond recognition. Increased regulatory requirements have meant that much more data is now being recorded; data that must be turned into useful information that is immediately available across the enterprise. This leverages operational excellence by allowing rapid business decisions based on better information, driving up efficiency whilst reducing costs. New technologies have facilitated the extension of the LIMS outside the traditional confines of the laboratory, providing deployment options that allow remote access from satellite laboratories, field workers, customers etc. This has meant that the LIMS can truly be considered an enterprise level business system, with the capability to be deployed globally irrespective of different time zones or local languages.
All this has meant that the modern LIMS is designed to be much more flexible than its predecessors. This flexibility can take several forms. A modern LIMS makes extensive use of workflows that can be easily configured to match existing business processes, meaning that LIMS implementation no longer requires that these processes must be re-engineered. Workflows determine the steps that define the sample life cycle, including batch release. They also cover supporting processes such as specification review and release. Workflows also define the testing procedures, which may consist of multiple, non-linear steps. Each step may involve the recording of data, and the result for a given step may determine which of several possible next steps should be performed. In earlier systems, typically only the final outcome of the test was recorded in the LIMS; in modern systems, the LIMS leads the operator through the defined steps making appropriate recommendations based on the entered results, the raw data or a resource reference.
Automated Workflow Management
This leads us to another development in LIMS; the increased capability of recording business logic within the system where it can be automated, rather than within procedures which must be manually implemented. For example, the steps involved in a failure investigation are traditionally maintained as a procedure that the analyst follows, possibly using the LIMS to record the various findings. In the modern LIMS, the steps to be performed are defined in a workflow, with the possibility of different workflows for different types of sample. The workflow can be configured using graphical tools, with decision points and storage of required information at each step, as shown in Fig. 1. For example, a checklist of questions accompanies the Assign Cause step to facilitate the recording of information.
Figure 1 : Configuration of Failure Investigation Workflow
Electronic Record Management
A modern LIMS also offers powerful electronic record management options, enabling the secure storage of a wide range of textual and graphical documents. Examples include instrument-generated graphics, such as chromatograms or spectra, as well as digital photographs, raw data files, standard operating procedures, analyst certifications, electronic training materials, investigation reports, scanned certificates of conformance from suppliers etc. Graphical data, such as chromatograms, which are normally only viewable using specialist software, can be transformed into a scalable vector format enabling reproduction without access to the original software. Systems also offer parsing mechanisms that allow meaningful extraction of the data, providing the opportunity for powerful query and analysis. The parsing process turns the raw data into meaningful and actionable information, which, through the use of smart routing functions, can be made available throughout the organisation and beyond.
The services offered by the laboratory may be customised for each market in terms of testing regimen, provision of different sample registration screens to facilitate collection of project specific information, reporting needs (format, naming conventions, reporting units, language etc), QC requirements etc. This allows the laboratory to provide an appropriate response that meets the specific market’s need, without involving its staff in additional, tedious work.
The power and flexibility of the modern LIMS are not just limited to laboratory operations. Many companies have initially implemented LIMS for their laboratory, and then extended the system to cover areas normally considered outside the scope of a laboratory information management system. Such areas have included stock control, product blending, tank farm management and average weights systems designed to ensure that pre-packaged goods meet relevant weights and measures legislation. This has lead to additional benefits, such as full batch traceability (Fig. 2), enabling a manufacturer to readily determine exactly which batches of raw material were used in a specified batch of final product, or vice versa.
Figure 2 : Simple Traceability for a Specified Batch of Final Product
The increased regulatory requirements have also lead to improved traceability of results. Whereas LIMS traditionally just stored the final result, with perhaps some additional information about how that result was obtained, a modern system provides full result traceability, as shown diagrammatically in Fig. 3. Starting with a single result, an auditor can see which member of staff performed the analysis and have access to their training/certification records to determine whether they were qualified to perform the work. He or she can identify the instrument that was used, and have access to the instrument’s calibration and maintenance records, as well as to documents and graphics (e.g. chromatograms, spectra, photomicrographs etc.) produced by the instrument during the analysis. The relevant quality control samples can also be inspected, together with details of the reagents and standards used to prepare them. Chain of custody records for the sample concerned are available. Any changes to the entered data are listed, together with reasons as to why they were necessary. Changes to the testing regime (such as addition of extra tests) are also fully documented. All this helps to ensure the validity of results, providing a higher degree of confidence in the analysis.
Figure 3 : Closed Loop Traceability
New technical developments are also revolutionising LIMS. The advent of web-enabled systems has provided a paradigm shift in technology, enabling LIMS access from almost anywhere. Extensible Markup Language (XML) is a simple, very flexible text format that was originally designed to meet the challenges of large-scale electronic publishing. It is rapidly becoming the common data language, playing an increasingly important role in the exchange of a wide variety of data on the Web and elsewhere. When coupled with Web Services (web-based enterprise applications that use open, XML-based standards and transport protocols to exchange data with calling clients), the power of XML becomes fully evident. No longer is it necessary to create expensive custom interfaces to enable communication between disparate business systems. Using web services, one system can use the exposed functionality of another as if it were its own. For instance, when a new batch of raw material arrives, the details are entered into a Manufacturing Resource Planning (MRP) system and the lot placed in quarantine awaiting laboratory analysis. The MRP system can call a “Sample Login” service published by the LIMS and provide a Data Transfer Object (DTO) that includes the relevant information about the sample that should be logged. The web service performs the relevant sample registration transactions on the LIMS, hiding their complexity from the calling application. Once the sample has been processed in the laboratory and shown to meet specification, the LIMS can invoke a web service published by the MRP system that will update the lot status, releasing the raw material for use.
Web services can also be used to create an efficient and secure relationship with remote customers, suppliers or data clients, allowing them to request sample analysis, view testing status and print certificates of analysis, invoices or other reports via a browser based interface. This means that clients can access an organisation’s LIMS securely without having to download and install special software.
A collaborative LIMS can provide vital information throughout the manufacturing cycle. Providing quality data determined by inspection of raw materials can provide the needed information to tune the production process to yield acceptable final products. An integrated production and laboratory solution can alert purchasing to procure additional raw material if a lot fails incoming inspection. Shipments can be quickly released after final quality control checks. Should a non-compliant lot be inadvertently shipped, fast efficient flow of information will ensure a recall can be quickly implemented. Without traceability records, it would be nearly impossible to accomplish product recalls in a timely manner. Additionally, implementation of a LIMS informed logistics and scheduling system at various stages of production can better manage the delivery of products by taking appropriate action to accommodate unplanned production issues.
Traditionally, laboratories have operated autonomously and are among the last domains to be fully integrated into the overall organization. LIMS applications typically focused on organizing laboratory data, tracking samples and providing results, often only in the form of a pass or fail for the lot. Increasingly sophisticated manufacturing processes in industries such as chemical, food & beverage, and pharmaceutical are dramatically increasing the number of laboratory analyses required. Increased product quality and increasing regulatory compliance issues means that laboratory data must be readily accessible to both people and systems across the enterprise. Manufacturers are now discovering that quick access to laboratory data is just as valuable to operations as it is to achieving regulatory compliance. They are also beginning to realise that LIMS data is as important as other sources of real-time data in the manufacturing process, and that the data must be integrated with other business and process control systems to enable Real-time Performance Management (RPM) initiatives. The recent developments within LIMS have meant that collaborative LIMS solutions have “come of age”, and result in productivity gains and reduced costs across the organisation, leveraging Operation Excellence.