A LIMS (Laboratory Information Management System) is a software-based solution that supports productivity and efficiency in modern labs in research and development, analytical research, quality assurance, quality control, technical services, manufacturing, contract research and other environments, across a wide range of industries. A LIMS interfaces with the lab’s automated systems, measurement and analytical instruments and software to oversee and manage complex laboratory processes. Connecting through system-to-system communications via file transfer, web services, and direct database communications, a modern LIMS will also interface with enterprise software, such as ERP platforms, inventory and accounting tools, to automate instrument calibration and maintenance scheduling, order reagents and consumables, and even manage staff training and invoicing.
By interfacing with and connecting these lab and enterprise ecosystems a LIMS can dramatically reduce or even eliminate the need for manual data entry and reporting, manage high-throughput, high-content workflows, and allow users to access and interrogate diverse datasets to improve intelligence and aid in business decision making. Validated LIMS systems support the assurance of data security, integrity1 and traceability end-to-end, to help businesses in regulated industries adhere to standards and requirements and reduce delays at audit.
What are the benefits of LIMS?
Paper-based and outdated systems in silos for managing laboratory workflows are subject to human errors in data entry, transcribing, reporting, and filing. Additionally creating, storing, and managing files or paper records can be both costly and time consuming. Paper-based or scattered data in many files or systems, also can’t be compared and analyzed in context, and therefore a lot of intelligence embedded in that data is lost.
In contrast, a LIMS allows the lab to:
- Derive an integrated picture of all resources taking part in a specific analysis (scientists, equipment).
- Manage samples and testing from sample receipt and scheduling, through to results reporting, and generating certificates of analysis or patient reports.
- Manage biological samples and processing requests like creation of aliquots, derivatives, packing and shipping, as well as tracking freezer and container storage space.
- Manage instrument calibration and maintenance schedules, automate consumables and reagents ordering, and schedule staff test method training.
- Manage clinical trials protocols and specifications such as treatment groups or cohorts, facilities, kits, and schedules for visits and timepoints.
- Make data available to all authorized personnel in different departments, in real time, and automatically alert staff when reports or certificates are ready to view or tasks need to be performed.
- Ensure adherence to defined SOPs, by making sure that each workflow stage is completed correctly, by authorized personnel, before allowing progress to the next stage.
- Fully trace lots and inventory through lot genealogy and chain of custody support.
- Manage and track auditable electronic records, ensuring a transparent chain of custody.
- Perform trend analysis and flag up adverse trends or outliers to facilitate a speedy response.
- Automatically flag and immediately compare results in real time against defined specifications.
ELN and SDMS
Labs may also combine a LIMS with an electronic laboratory notebook (ELN) platform that effectively offers each person in the lab a digital solution for recording and reporting experiments and results. ELNs aid in experimental and quality control data sharing and collaboration, make it easy to find and adhere to SOPs, and facilitate data and results searching, mining and analysis. Alongside the LIMS and ELN, a scientific data management system (SDMS) will commonly act as a central repository for an organization’s documents and data, making it easy to find and access information across departments and sites. In addition, SDMS facilitates the automatic parsing on instrument data from standalone systems.
The combination of LIMS deployment in the cloud, with mobile connectivity then makes collective data available to lab personnel and stakeholders anywhere in the world, at a desktop or on mobiles and tablets, when on the move or at remote sites.
Who uses LIMS?
LIMS systems can be used by any authorized personnel in the lab and across an enterprise, from scientists and technicians, to lab and business managers, and top-level stakeholders, across industries as diverse as bio/pharmaceutical Quality Control and R&D, contract research and manufacturing, food and beverage, chemicals, petrochemical, oil and gas, utilities and environmental, mining, and the automotive sector.
Critically, Laboratory Information Management Systems systems help businesses in regulated industries comply with their required national and international standards. For pharmaceutical companies, for example, the regulatory requirements can include current Good Laboratory Practice (cGLP), current Good Manufacturing Practice (cGMP) and FDA 21 CFR Part 11, NELAC and ISO 17025 in water and food testing laboratories or NAMAS/UKAS regulations, Good Clinical Laboratory Practice (GCLP) for clinical trials and HTA, GCLP, MHRA, FDA 21 CFR Part 11 and other similar requirements in biobanking.