The LIMS is an evolving concept, with new features and functionality being added often. As laboratory demands change and technological progress continues, the functions of a LIMS will likely also change. Despite these changes, a LIMS tends to have a base set of functionality that defines it. That functionality can roughly be divided into five laboratory processing phases, with numerous software functions falling under each:
•• the reception and log in of a sample and its associated customer data
•• the assignment, scheduling, and tracking of the sample and the associated analytical workload
•• the processing and quality control associated with the sample and the utilized equipment and inventory •• the storage of data associated with the sample analysis
•• the inspection, approval, and compilation of the sample data for reporting and/or further analysis
There are several pieces of core functionality associated with these laboratory processing phases that tend to appear in most LIMS:
Sample management
A lab worker matches blood samples to documents. With a LIMS, this sort of sample management is made more efficient.
The core function of LIMS has traditionally been the management of samples. This typically is initiated when a sample is received in the laboratory, at which point the sample will be registered in the LIMS. This registration process may involve accessioning the sample and producing barcodes to affix to the sample container. Various other parameters such as clinical or phenotypic information corresponding with the sample are also often recorded. The LIMS then tracks chain of custody as well as sample location. Location tracking usually involves assigning the sample to a particular freezer location, often down to the granular level of shelf, rack, box, row, and column. Other event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory may be required.
Modern LIMS have implemented extensive configurability, as each laboratory's needs for tracking additional data points can vary widely. LIMS vendors cannot typically make assumptions about what these data tracking needs are, and therefore vendors must create LIMS that are adaptable to individual environments. LIMS users may also have regulatory concerns to comply with such as CLIA, HIPAA, GLP, and FDA specifications, affecting certain aspects of sample management in a LIMS solution. One key to compliance with many of these standards is audit logging of all changes to LIMS data, and in some cases a full electronic signature system is required for rigorous tracking of field-level changes to LIMS data.
Instrument and application integration
Modern LIMS offer an increasing amount of integration with laboratory instruments and applications. A LIMS may create control files that are "fed" into the instrument and direct its operation on some physical item such as a sample tube or sample plate. The LIMS may then import instrument results files to extract data for quality control assessment of the operation on the sample. Access to the instrument data can sometimes be regulated based on chain of custody assignments or other security features if need be.
Modern LIMS products now also allow for the import and management of raw assay data results. Modern targeted assays such as qPCR and deep sequencing can produce tens of thousands of data points per sample. Furthermore, in the case of drug and diagnostic development as many as 12 or more assays may be run for each sample. In order to track this data, a LIMS solution needs to be adaptable to many different assay formats at both the data layer and import creation layer, while maintaining a high level of overall performance. Some LIMS products address this by simply attaching assay data as BLOBs to samples, but this limits the utility of that data in data mining and downstream analysis.
Electronic data exchange
The exponentially growing volume of data created in laboratories, coupled with increased business demands and focus on profitability, have pushed LIMS vendors to increase attention to how their LIMS handles electronic data exchanges. Attention must be paid to how an instrument's input and output data is managed, how remote sample collection data is imported and exported, and how mobile technology integrates with the LIMS. The successful transfer of data files in Microsoft Excel and other formats, as well as the import and export of data to Oracle, SQL, and Microsoft Access databases is a pivotal aspect of a the modern LIMS. In fact, the transition "from proprietary
databases to standardized database management systems such as Oracle ... and SQL" has arguably had one of the biggest impacts on how data is managed and exchanged in laboratories.
Additional functions
Aside from the key functions of sample management, instrument and application integration, and electronic data exchange, there are numerous additional operations that can be managed in a LIMS. This includes but is not limited to:
audit management
fully track and maintain an audit trail barcode handling
assign one or more data points to a barcode format; read and extract information from a barcode chain of custody
assign roles and groups that dictate access to specific data records and who is managing them compliance
follow regulatory standards that affect the laboratory customer relationship management
handle the demographic information and communications for associated clients document management
process and convert data to certain formats; manage how documents are distributed and accessed instrument calibration and maintenance
schedule important maintenance and calibration of lab instruments and keep detailed records of such activities inventory and equipment management
measure and record inventories of vital supplies and laboratory equipment manual and electronic data entry
provide fast and reliable interfaces for data to be entered by a human or electronic component method management
provide one location for all laboratory process and procedure (P&P) and methodology to be housed and managed
personnel and workload management
organize work schedules, workload assignments, employee demographic information, and financial information
quality assurance and control
guage and control sample quality, data entry standards, and workflow; reports
create and schedule reports in a specific format; schedule and distribute reports to designated parties time tracking