The emergence of LIMS
Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in
the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in
the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.
In the early evolution of laboratory information systems as data management tools, LIMS were essentially developed in-house
by scientists to satisfy a defined need. Those early LIMS were eventually brought to market by vendors to fulfil a growing
need in the industry. While the emergence of LIMS sprang from the environmental industry, the pharmaceutical industry was
an early adopter as a result of growing regulatory pressures; increased sample throughput; demand for more efficient management;
the need to eliminate human error; and a drive for integrating data throughout the enterprise.
Evolution of pharma LIMSLIMS were readily adopted in the pharmaceutical industry because they increasingly met industry-specific requirements, in
place of organization-specific requirements. The need for organizations to comply with regulatory and manufacturing processes
such as cGMP, NAMAS (National Accredititation of Measuring and Sampling), Environmental Protection Agency (EPA), FDA and GLP/GALP
was a driving factor in the pharmaceutical industry's early acceptance of LIMS.
Selecting a LIMS — a historical perspective
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However, with time many early users were left with heavily customized legacy systems that proved difficult to upgrade and
integrate with other business functions. As the industry itself changed, and merger and acquisition (M&A) activity altered
the pharmaceutical landscape, application integration became a necessity to ensure that laboratories made their data accessible
throughout the enterprise. After 10–15 years, homegrown legacy systems had become almost obsolete — replaced by more available,
upgradeable and compliant vendor-supplied generic LIMS. These early systems, while designed to provide basic data management
and meet regulatory compliance, required a high degree of customization to meet the specific needs of each particular user
group across the enterprise. LIMS were not customarily designed to operate at full functionality, which required pharma users
at the research, development or manufacturing phase of drug development to 'customize' the LIMS for that particular laboratory
application with its specific workflow and data management requirements.
Past technology trends
Technology has played an important role in the changing face of LIMS. In-house LIMS were typically based on simple spreadsheet
packages, while vendor-developed LIMS were frequently modelled on minicomputer platforms, such as Digital's VAX running the
VMS or UNIX operating systems. These LIMS had the advantage of being multiuser, secure and centrally administered. Increasingly,
business rules such as operator approvals, test schedules, templates and the core database became centralized server-based
activities. Against this background ran the contra-argument for PC-based integrator systems, which claimed that support costs
for minicomputers and associated software were more costly.
Current trends (2007)
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PC-based solutions were then based on the basic Windows platform on top of a DOS operating system. Disadvantages were lack
of security, the need to copy methods onto all machines individually rather than centrally when alterations were required,
and a relative lack of processing power (PCs were costly 10 years ago, and so inevitably many organizations consigned their
slowest PCs to the task of laboratory data collection and analysis — which up to that point had been done manually).
