By Stefano Marocco, Account Manager and 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 and so on.
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 were. 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 a 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, operating procedures, analyst certifications, electronic training materials, investigation reports, scanned certificates of conformance from suppliers and so forth.
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 organization and beyond.
The services offered by the laboratory may be customized for each market in terms of testing regimen, provision of different sample registration screens to facilitate collection of project specific information, reporting needs (such as format, naming conventions, reporting units, and language), QC requirements and so on. 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 led to additional benefits, such as full batch traceability, enabling a manufacturer to readily determine exactly which batches of raw material were used in a specified batch of final product, or vice versa.
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.
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 (for example chromatograms, spectra and photomicrographs) 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 is 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.
For more information visit
www.starlims.com
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Stefano Marocco is an Account Manager at the UK STARLIMS office. Primarily an expert in LIMS implementation, he offers advice on how to develop time- and cost-effective solutions that optimise automation of laboratories' operations, and ways to manage samples in an environment that complies with regulatory requirements. Stefano holds an honours degree in Business Studies from South Bank University, London. He has over five years' experience in the LIMS industry, particularly in the pharmaceutical sector, gained with various solution providers.
Elian Winstanley has been involved with LIMS since the early 1990s. He has led teams who have successfullyimplemented LIMS for clients in a wide variety of market sectors including pharmaceutical, environmental monitoring, chemical manufacturing, food and beverage and contract laboratories. After graduating from Manchester University with a joint honours degree in Pharmacology and Physiology, followed by a masters in Physiology, he worked as a Liquid Chromatography and Data Systems specialist for a major laboratory instrument supplier before moving to laboratory information management. He currently manages the UK STARLIMS office.
The authors can be contacted at stefano@starlims.com
and elian@starlims.com
