LIMS feature

A LIMS feature is one or more pieces of functionality that appear within a laboratory information management system (LIMS).

The LIMS is an evolving concept, with new features and abilities being introduced every year. As laboratory demands change and technological progress continues, the functions of a LIMS will also change. Yet like the automobile, the 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

Of course, there are LIMS features that are difficult to categorize under any of these phases. Such features often contribute to the entire LIMS and how it's utilized. For example, multilingual support appears in LIMS like Assaynet Inc.'s LIMS2010 and Two Fold Software's Qualoupe LIMS, allowing users to interact with the LIMS in more than one language. Some functionality may also overlap several laboratory phases, making it difficult to firmly classify.

The features described below come from an analysis of freely available LIMS product information on vendor websites. An attempt was made to discover the features most utilized in vendors' LIMS products and collect information on those features for each LIMS. Not every possible feature is referenced here; some LIMS products fill specific niches, utilizing very unique functionality to solve a specific problem.

That said, keep in mind the categorization of features below is very loose. It may be viable to argue a feature belongs under a different section or multiple sections. For the purposes of organizing this information in an uncomplicated manner, however, some liberty has been taken in the categorizing of features.

Sample, inventory, and data management

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Sample login and management

Sample management is one of the core functions a modern LIMS is tasked with, whether it's in a manufacturing, water treatment, or pharmaceutical laboratory. As such, researchers who work in these types of labs are unable to complete their experiment-based goals without an effective method of managing samples. The process of sample management for experiments includes, but is not limited to:

• storing related sample information, including aliquot numbers, dates, and external links
• setting user alerts for sample status
• creating and documenting viewable sample container schemas with name and status
• assigning sample access rights
• assigning custom sample ID numbers based on a specification

Additional functionality that could potentially fall under this feature:

• utilizing a unique ID system
• barcoding of samples
• defining sample points and series
• creating data associations for samples
• issuing sample receipts

Sample tracking

Where's sample 20110512_122GJH? Sample tracking functionality will let you know which lab oven it's in.

For most laboratory personnel, knowing that a sample has arrived to the lab isn't good enough; they need to know where it's located and what is being done with it. Enter the sample tracking feature. Without it, many problems arise. In the forensic world, for example, many samples are linked to a criminal investigation. In this case, misidentification, contamination, or duplication can become significant issues: a lost sample is essentially missing evidence, while a duplicated sample can render it useless as evidence.

After sample reception and its initial handling procedures, many LIMS can then track sample location as well as chain of custody. 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. The process of tracking a sample has become more streamlined with increasing support of 2-D barcode technology. While handwritten labels were the norm, now barcode support in a LIMS can "tie together a vast amount of information, clearly relating each sample to a specific case." Other event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory may also be required. As each laboratory's needs for tracking additional data points can vary widely, many modern LIMS have implemented extensive configurability to compensate for varying environments.

The functionality of sample tracking strongly ties into the audit trail and chain of custody features of a LIMS.

Sample and result batching

What is batching? The United States Environmental Protection Agency (EPA) defines a batch as "a group of samples which behave similarly with respect to the sampling or testing procedures being employed and which are processed as a unit." This definition can be applied to many laboratories which handle large quantities of samples for some form of analysis or processing. A LIMS that has the ability to check in, link, and track groups of samples across one or multiple facilities is valuable to such laboratories. Additionally, batching the analysis results of multiple samples or groups of samples gives laboratories more flexibility with how they manage their data. Batching also offers the benefit of mimicking the production groups of samples while also capturing quality control data for the entire group.

Task and event scheduling

Within the context of a LIMS, the ability to schedule a task or event is a natural extension of how work was done in a laboratory before the advent of data management systems. Workloads are assigned to technicians, maintenance schedules are created and followed, and research deadlines must be observed. While these tasks have in the past been performed without LIMS, a modern data management system can now optimize those tasks and provide additional scheduling functionality to streamline the operation of a lab. Autoscribe Ltd., for example, offers a scheduling module for its LIMS that allows users to automatically schedule multiple jobs, data backups, alarms, and reports. Some LIMS like LabWare, Inc.'s LabWare LIMS offer multiple types of schedulers that match to the particular functions of a research laboratory. Additional functionality within this feature includes the ability to configure automated assignments of analysis requests, establish recurring events, and in most cases, create printable schedules.

Examples of tasks and events that can feasibly be scheduled in a LIMS include:

• registration of received samples into the system
• production of reports
• creation and sending of e-mails and alerts
• maintenance of equipment
• assignment of workloads to personnel

Option for manual result entry

While many LIMS vendors tout the ability of their product to automate the entry of results into the LIMS database, the need for manual data entry of analysis results still exists. This feature is important to laboratories obtaining analysis results from multiple sources, including non-digital paper-based results and instruments that can't be connected to the LIMS. Additional functionality associated with this feature includes a customizable spell check dictionary and the ability to add comments, notes, and narratives to most anything in the LIMS.

Multiple data viewing methods

Laboratories produce data, and LIMS exist to help manage that data. Additionally, even before the existence of LIMS, scientists have had a corresponding need for visually representing data. Today a LIMS can not only collect and analyze data from samples, but it also can represent that data in reports, graphs, gradients, and spreadsheets. Depending on the LIMS, more than one way to visually represent the data may exist.

Some laboratory information management systems take a very specialized approach to data views. For example, Biomatters Ltd.'s Geneious and Geneious Pro offer multiple methods of viewing complicated sequence analysis data, including 3-D structuring and representations of plasmid vectors.

Data and trend analysis

Some LIMS allow users to analyze sample data directly from the software.

Sample experimentation and analysis plays an important part of laboratory informatics, helping laboratories make better sense of their experiments and reach valuable conclusions about them. While this important phase of laboratory work has often been done externally from the LIMS, it's now more common to see basic analysis tools being included. Such tools allow raw data to be imported directly to the LIMS, which then can store, process, and report information about it. Additionally, calculations and functions used in the analysis are typically definable and editable for further flexibility.

As with the feature "multiple data viewing methods," data and trend analysis is also increasingly important in laboratories that have very specialized data management needs. When even in 2009 genetic scientists in large- and medium-sized sequencing and core centers were voicing concerns about "a lack of adequate vendor-supported software and laboratory information management systems (LIMS),", today data management options like the previously mentioned Geneious Pro are starting to emerge, offering the ability to perform specialized analytical tasks for the sequencing industry.

As sample experimentation and data analysis are important parts of most if not all laboratories, such functionality — which has often come in the form of a separate application or analysis device — will likely continue to merge into LIMS and other data management solutions.

Data and equipment sharing

Aside from data storage and sample registration, a modern LIMS' major contribution to the laboratory is aiding in the sharing of experiment results, reports, and other data types with those who need it most. Rather than pieces of information becoming misplaced or forgotten in laboratory notebooks, the LIMS makes it easier to share sample test results and increase the efficiency of collaboration inside and outside the laboratory. Yet data is more than just sample test results; it also can come in the form of charts, reports, policy and procedure, and other documents. Additionally, the need for controlling who has access to those types of data is also an important consideration. As such, this feature is at least partially tied to other features like document management and configurable security.

Customizable fields and/or interface

As thorough as some user interface (UI) developers may be in adding relevant fields and interface options for LIMS end users, there are at times options that are either omitted or unanticipated. This has traditionally required the end user to contact the vendor and ask if the needed option(s) can be added in the next release. However, some modern LIMS vendors have responded instead by adding functionality that gives end users and/or LIMS administrators more control over the user interface.

Aspects of the LIMS' user interface that are becoming more customizable by the end user include:

• system nomenclature
• equations used in calculations
• data and universal fields
• appearance of the interface and/or menus
• primary system language
• the LIMS source code, especially if in a non-proprietary format

Query capability

Advanced query tools allow researchers to better complete project objectives.

As was the case before the advent of databases and electronic data management solutions, today researchers must search through sample results, experiment notes, and other types of data to better draw conclusions about their research. Whereas this used to mean browsing through laboratory notebooks, Excel spreadsheets, or Access databases, now powerful query tools exists within data management tools like a LIMS. Not only can data be searched for based on name, number, or vendor, LIMSs like eBioSys' eLab and Mountain States Consulting's MSC-LIMS allow for queries of attached meta-data like user ID, project number, task number, sample type, location, and collection date. Finally, as LIMS continue to include both sample management and experimental data management functionality, queries become more powerful in general as now sample and experiment can be matched together in one database.

Query functionality often includes the ability to:

• search both transactional data and archived data tables
• search multiple databases via an application programming interface (API) or open database connectivity (ODBC) connection
• filter and sort data
• create ad-hoc queries

Import data

Data can originate from numerous places in the laboratory. The ability to import that data into a LIMS can be beneficial, especially when an instrument can't be connected or an external client provides a data feed independent of the LIMS. Some LIMS like Bridge-Soft's QMS even allow to cross-reference laboratory nomenclature from received data sources with the recipient's. And of course instrument interfacing allows for even more importation options. Additional data validation procedures may be applied to the imported data to guarantee information homogeneity. Additionally, some LIMS may allow for the import and integration of non-normalized legacy data tables with LIMS data tables into a single database.

Internal file or data linking

This feature allows LIMS users to link together reports, protocols, sample results, and more, providing greater contextual clarity to projects. Examples include:

• linking a sample batch to a test or sample preparation methodology
• linking a test process to a particular customer
• linking a report to a sample batch
• linking a group of test results to a raw data file
• linking an image to a work order
• linking all lab results with the correct reporting test method

External file or data linking

This feature allows LIMS users to link together data and files in the LIMS with data, files, and customers outside the scope of the LIMS. Examples include:

• linking data files from chromatography equipment to synthesis data
• linking equipment ID with an external annotation database
• linking external standard operating procedure documents with an internal test specification

ELN support or integration

As a software replacement for more traditional paper laboratory notebooks, the electronic laboratory notebook (ELN) has been important to laboratory functions. Yet the lines between ELN and LIMS began to blur in the 2000s, with both types of software incorporating features from the other. The result today is some LIMS either include traditional ELN functionality or link physical laboratory notebook references to data in the LIMS.

Export to MS Excel

While Microsoft Excel has long been used within the laboratory setting, a slow shift towards relational databases and LIMS occurred in the late 1990s and early 2000s. Additional concerns with the difficulties of Excel's validation and compliance with FDA 21 CFR Part 11 and other regulations have led many labs to turn to data management solutions that are easier to validate. Nevertheless, laboratories continue to use Excel in some fashion, and thus Excel integration or data exportation in Excel format is a real need for LIMS customers. LIMS with this feature allow raw, processed, or imported data to be exported in the Excel format for further analysis and dissemination.

Export raw data

While not described as a feature on most LIMS vendor websites, a few indicate that their LIMS is capable of maintaining and exporting data in its raw format for future analysis.

Data warehouse

A LIMS' data warehouse serves the important function of storing, extracting, and managing the data that laboratories crank out for the purposes or analysis, reporting, and process management, typically separate from the primary storage database. Data warehouses also offer the benefit of speeding up queries, making queries and data mining more user-friendly, and smoothing out data gaps.

Deadline control

Deadline control is functionality within a LIMS that allows users to manage and be notified of events that occur within the laboratory. With this functionality users can also be notified of upcoming deadlines on anything from sample analysis to license renewal.

Note that this functionality may also feasibly fall under the task and event scheduling or alarms features. As deadline control seems to be advertised as a notable feature by only a few vendors, it seems even more likely that this functionality is considered part of scheduling or alarms.

Production control

There are many types of businesses that produce goods, and in most cases there is a research laboratory involved at some point in the process. This is especially true in the pharmaceutical and chemical industries, where production measurements such as yield, volume, activity, and impurity are vital. As LIMSs have already recorded such information during tests and analysis, the addition of production control functionality seems natural. Some LIMS take a very active approach to this. For example, 2nd Sight Solutions' OhNo! features production control as major functionality for the synthesis of radiopharmaceuticals. Other LIMS may have less pronounced production functionality, while still offering the ability to track the production process in and out of the lab. And yet other LIMSs like dialog's diaLIMS offer robust production-based functionality but as a module or add-on to the base LIMS software.

The types of functionality that may fall under this feature include:

• recipe management
• consumable tracking
• batch traceability
• production planning
• enterprise resource planning

Project and/or task management

Project and task management within a LIMS typically involves the scheduling of tasks to workers and organizing associated tasks into a more cohesive unit for better tracking and management. While the functionality of task and event scheduling can also be found in project and task management, many LIMS include functionality beyond scheduling that warrants the addition of the project and/or task management feature. This functionality includes:

• job allocation and rescheduling
• instrument workload tracking
• time tracking
• pending workload verification
• priority setting
• project-based workflow management
• sample, batch, and document linking
• work list sharing
• recurring event management

Inventory management

LIMS can help laboratories keep track of their stock of reagents and even streamline reordering of them.

Laboratories use a wide array of inventory, from reagents to glassware, from radiopharmaceuticals to laboratory baths. With that comes the need to know how much/many and the frequency of use. For this, most LIMS products now include some sort of inventory management functionality.

• register origin, demographics of incoming materials
• track used and in-use items via barcodes
• track inventory reduction based on usage and shipping out of the lab
• create alerts for when items reach a certain stock level
• calculate inventory cost and fluctuation
• manage transportation and routing
• manual incrementing/decrementing of items
• track location and usage of laboratory equipment
• assign storage locations
• track forensic evidence

It should be noted that samples and electronic equipment may also be considered inventory, and thus there is likely some functionality crossover with the sample management and instrument management features.

Document creation and management

Standard operation procedures, (SOPs), specifications, reports, graphs, images, and receipts are all collected and used in the average laboratory. With a LIMS already designed to manage and store sample and experiment data, it makes sense to include functionality to create, import, export, and manage other sorts of data files. As sample and experimental data can be indexed, queried, and linked, so too can document data. Functionality of a typical document management system includes the ability to:

• upload and index documents
• enforce version control
• provide full text search
• export to PDF or other relevant format
• add documents as attachments

Case management

The laboratory information system (LIS) has played an important role in the case management tasks of patient-centric and clinical laboratories. However, some LIMS have gained case management functionality, effectively blurring the lines between LIS and LIMS.. Self-proclaimed LIMS products have emerged in the clinical, public health, and veterinary industries, areas that have historically been served by LIS software. When also considering the fields of law enforcement and forensic science, case management has an increasingly important role in some LIMS. Functionality seen in the case management feature includes:

• case accessioning and assignment
• disease tracking
• trend analysis
• clinical history follow-up
• out-of-range result alerts
• document and result association
• evidence control
• study management

Workflow management

Capturing workflow in the lab is becoming more commonplace for the LIMS.

Workflow management is common in the laboratory, acting as a graphical representation of planned sequential steps to either fully or partially automate a process within the lab. Separate standards-based workflow management systems (in the form of a software component) have traditionally performed this task. However, in the 2000s LIMS vendors began incorporating workflow management functionality into their LIMS software, reducing the headaches that customization of a LIMS often brought.

Modern commercial and open-source LIMS solutions often feature workflow management functionality, including:

• attribute definition of activities
• definition of inputs and outputs of activities
• assignment of documentation to activities
• setting of quality control limits
• dynamically modify workflow in case of future changes
• receive notification of changes to the workflow
• sending user-defined messages during the process

Specification management

Specification (spec) management is vital to not only the manufacturing and research industries but also to a host of other laboratories requiring precise measurements and infallible test methods. Just as the ASTM offers standards and specs for LIMS, so too do LIMS users have standards and specs for their laboratory. With spec management in place within the LIMS, laboratories can then:

• enforce standard operating procedures and business rules
• create specs down to a project or sample level
• validate recipes and procedures
• accept or reject sample batches
• document internal and external spec history

Note that some of the functionality of spec management may cross over into the realm of quality control and data validation.

Customer management

Unless a laboratory is conducting internalized independent research, in most cases it will do business with external entities such as contract labs, sample providers, and equipment providers. In some cases, even internal employees may be considered a customer, necessitating documentation of who is using the system and in what ways. For a veterinary lab, the customer may be the animal and handler. For a forensic lab the customer may be more complex: internal staff, university staff, police departments, and maintainers of nationwide crime databases may all at some point act as customers. In these cases, documenting these various points of contact and linking them to samples, equipment, and tests becomes vital. Managing demographics, complaints, correspondence, and history are all feasible with customer management functionality. This process is often made simpler through the use of a more context-neutral entity creation system, which allows for more flexible management of contacts.

This feature may also be referred to as contact management, an address book module, or a customer service module.

Billing management

While the finances of a laboratory are important, they've typically been handled separately as a business process. However, some LIMS include additional functionality to make handling financial transactions and documentation of all sorts possible within the LIMS. In theory, such functionality brings the possibility of keeping more of a laboratory's data centrally located and queryable. This feature may include:

• payment processing
• expense reporting
• price quotes
• revenue management
• workload tracking of billable hours
• bill of materials
• grant management

 

Quality, security, and compliance

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Regulatory compliance

The topic of whether or not a LIMS meets regulatory compliance is often a complex one. While Title 21 CFR Part 11 has arguably had the largest influence on a electronic data management system's compliance, other influential standards have shaped the way LIMS and other systems handle and store data. Other compliance-based codes, standards, and regulations include:

• ASTM
• ASCLD/LAB
• Classified data
• Freedom of information legislation (various)
• GALP and GAMP
• HIPAA
• Health Level 7
• ISO/IEC 17025
• ISO 9000/9001
• ISO/TS 16949
• ODBC
• TNI and NELAP
• Title 40 CFR Part 3

With so many codes, standards, and regulations, LIMS consumers are advised to contact vendors with their user requirements and ask how the vendor's software meets and/or exceeds those requirements.

QA/QC functions

Performance evaluation

Audit trail

Chain of custody

Configurable roles and security

Data validation

Data encryption

Version control

Automatic data backup

Environmental monitoring

 

Reporting, barcoding, and printing

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Custom reporting

Report printing

Label support

Barcode support

Export to PDF

Export to MS Word

Export to HTML or XML

Fax integration

Email integration

 

Base functionality

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Administrator management

Modular

Instrument interfacing and management

Mobile device integration

Alarms and/or alerts

Work-related time tracking

Voice recognition system

External monitoring

Messaging

Multilingual

Network capable

Web client or portal

Online or integrated help

Software as a service delivery model

Usage-based cost