Difference between revisions of "LIS feature"

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===Sample tracking===
===Sample tracking===


[[File:Laboratory oven for samples-02.jpg|thumb|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.<ref name="ForensicSamp">{{cite web |url=http://new.americanlaboratory.com/914-Application-Notes/506-Effective-Forensic-Sample-Tracking-and-Handling/ |author=Murthy, Tal; Brian Hewson |title=Effective Forensic Sample Tracking and Handling |publisher=American Laboratory |date=01 September 2010 |accessdate=10 February 2012}}</ref>
[[File:Laboratory oven for samples-01.jpg|thumb|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.<ref name="ForensicSamp">{{cite web |url=http://new.americanlaboratory.com/914-Application-Notes/506-Effective-Forensic-Sample-Tracking-and-Handling/ |author=Murthy, Tal; Brian Hewson |title=Effective Forensic Sample Tracking and Handling |publisher=American Laboratory |date=01 September 2010 |accessdate=10 February 2012}}</ref>


After sample reception and its initial handling procedures, many LIS can then track sample location as well as [[LIS feature#Chain of custody|chain of custody]]. Location tracking usually involves assigning the sample to a particular freezer, oven, or other 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 [[LIS_feature#Barcode and/or RFID support|barcode]] or radio-frequency identification (RFID) technology. While handwritten labels were the norm, now barcode and RDIF support in a LIS can "tie together a vast amount of information, clearly relating each sample to a specific case."<ref name=ForensicSamp /> 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 and LIS have implemented extensive configurability to compensate for varying environments.<ref name="PP0102">{{cite journal |journal=ProEnvironment/Promediu |year=2008 |volume=1 |issue=2 |pages=19–23 |title=LIMS use in laboratory data management |author=Muntean, Edwarda; Nicoleta Munteanb; Tania Mihăiescua; Radu Mihăiescuc |url=http://journals.usamvcluj.ro/index.php/promediu/article/download/2835/2696 |format=PDF}}</ref>
After sample reception and its initial handling procedures, many LIS can then track sample location as well as [[LIS feature#Chain of custody|chain of custody]]. Location tracking usually involves assigning the sample to a particular freezer, oven, or other 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 [[LIS_feature#Barcode and/or RFID support|barcode]] or radio-frequency identification (RFID) technology. While handwritten labels were the norm, now barcode and RDIF support in a LIS can "tie together a vast amount of information, clearly relating each sample to a specific case."<ref name=ForensicSamp /> 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 and LIS have implemented extensive configurability to compensate for varying environments.<ref name="PP0102">{{cite journal |journal=ProEnvironment/Promediu |year=2008 |volume=1 |issue=2 |pages=19–23 |title=LIMS use in laboratory data management |author=Muntean, Edwarda; Nicoleta Munteanb; Tania Mihăiescua; Radu Mihăiescuc |url=http://journals.usamvcluj.ro/index.php/promediu/article/download/2835/2696 |format=PDF}}</ref>

Revision as of 21:46, 27 April 2013

You can find a listing of all LIS vendors — and by extension, the features their products offer — on the LIS vendor page.
Thousands of hospital laboratories like this one benefit from the use of a laboratory information system.

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

The LIS has traditionally been utilized in clinical, pathology, and medical research laboratories as well as numerous public health institutions.[1] Yet as laboratory demands have changed and technological progress has continued, the functions of a LIS have also changed, with the distinction between a LIS and a laboratory information management system (LIMS) fading as some LIMS vendors have adopted the case-centric information management normally reserved for a LIS.[2][3].

Despite the blurring of distinction between a LIS and a LIMS, the LIS generally continues to feature the following[4]:

  • patient management, including admission date, admitting physician, ordering department, specimen type, etc.
  • patient data tracking
  • decision support, including comparisons of lab orders with their respective ICD-9 codes
  • quality assurance of ordered tests
  • workload and management reporting

Of course, there are LIS features that are difficult to categorize or simply contribute to the whole of the LIS rather than add a function. For example, multilingual support allows users to interact with the LIS in more than one language. Some functionality may also overlap several research phases, making it difficult to firmly classify.

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

Experiment, patient, and data management

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.

 

Sample login and management

Sample login and management — often referred to as accessioning — is an important component of the clinical laboratory, whether it's a molecular pathology lab testing samples for disease indicators or a contract lab running pharmacokinetic and biomarker analysis on samples from a clinical trial.[5][6] As such, researchers and technicians who work in these types of labs are unable to complete their tasks without an effective method of managing samples. The process of sample management and accessioning includes, but is not limited to[7][5]:

  • storing related sample information, including demographics, dates, and external links
  • creating and documenting viewable sample container schemas with name and status
  • assigning sample access rights
  • assigning custom sample ID or accessioning numbers based on a specification
  • applying additional processing to the sample before storage and/or analysis

Additional functionality that could potentially fall under this feature:

  • barcoding of samples
  • defining sample points and series
  • creating data associations for samples - such as pedigree for sample/aliquot relationships or relationships based on experiment, etc.
  • 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.[8]

After sample reception and its initial handling procedures, many LIS can then track sample location as well as chain of custody. Location tracking usually involves assigning the sample to a particular freezer, oven, or other 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 or radio-frequency identification (RFID) technology. While handwritten labels were the norm, now barcode and RDIF support in a LIS can "tie together a vast amount of information, clearly relating each sample to a specific case."[8] 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 and LIS have implemented extensive configurability to compensate for varying environments.[9]

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

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."[10] 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 an ELN, 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. Experiments 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 ELN, a modern data management system can now optimize those tasks and provide additional scheduling functionality to streamline the operation of a lab. Some ELNs like Labtronics Inc.'s Nexxis ELN can schedule due dates on worksheets and experiments.[11] Additional functionality within this feature group includes the ability to configure automated assignments of experiment requests, establish recurring events, and in most cases, create printable reports.

Examples of tasks and events that can feasibly be scheduled in an ELN include:

  • production of reports
  • creation and sending of e-mails and alerts
  • maintenance of equipment
  • assignment of experiments to personnel

Option for manual result entry

While many ELN vendors tout the ability of their product to automate the entry of experiment results into the ELN 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 ELN. 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 ELN.

Multiple data viewing methods

Researchers produce reams of data, and the ELN exists to help organize and share that data. Additionally, even before the existence of the ELN, scientists have had a corresponding need for visually representing data. Today an ELN can not only collect and analyze data from experiments, but it also can represent that data in reports, graphs, gradients, and spreadsheets. Depending on the ELN, more than one way to visually represent the data may exist.

The ELN is particularly useful for displaying chemical structures and bonds in more than one way through built-in or integratable chemical structure drawing tools or through a document manager that can handle the placement of screenshots, sketches, or other images.

Configurable templates and forms

In the context of ELN, a template is a functionality item which allows users to increase the productivity and quality of their work by allowing for the creation of a standardized notebook page, experiment page, or workflow process which can be used by multiple researchers. These templates allow researchers to maintain more consistent data representation for similar tasks in the notebook and save time by not needing to manually input common data outputs or recreate workflows and experiments. Templates and forms typically utilize a wide field library, and the data that is posted to those template fields can also be normalized to a specific standard. Types of templates that may be created include those for renal and blood pressure analysis, glucose tolerance tests, or even stylized notebook templates for a specific research department.[12][13]

Data and trend analysis

Some ELNs allow users to analyze experiment data with built-in software tools.
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 ELN, it's now more common to see basic analysis tools being included. Such tools allow raw data to be imported directly to the ELN, which then can store, process, and display it in a shareable form. Additionally, chemical 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),"[14], today data management options like Scilligence ELN are starting to emerge, offering the ability to perform specialized analytical tasks for the researcher.[15]

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 software like ELN, LIMS, and other laboratory informatics solutions.[16]

Data and equipment sharing

Aside from data storage and sample registration, a modern ELN's major contribution to the laboratory is both in aiding in the sharing of experiment results, reports, and other research data with those who need it most and the documentation of vital evidence for potential patent interference cases. Rather than pieces of information becoming misplaced or forgotten in physical laboratory notebooks, the ELN makes it easier to share experiment results and increase the efficiency of collaboration inside and outside the laboratory. Yet data is more than just 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.

Data mining

Customizable fields and/or interface

As thorough as some user interface (UI) developers may be in adding relevant fields and interface options for eln 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, many modern ELN vendors have responded instead by adding functionality that gives end users and/or ELN administrators more control over the user interface.

Aspects of the ELN's user interface that are often customizable by the end user include:

  • notebook interface and display
  • chemical drawing methods and display
  • sharing options

Query capability

An ELN's query tools may be as simple as looking up demographic data or finding specific strings of characters in research data.
As was the case before the advent of databases and electronic data management solutions, today researchers must search through experiment results, 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 ELN and LIMS. Not only can data be searched for based on name, number, or vendor, ELNs like ChemBytes' Espresso ELN allow for advanced queries of molecular patterns and properties associated with the SMARTS language.[17]

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
  • collate queried data for further analysis and visualization
  • create ad-hoc queries

Import data

Data can originate from numerous places in the laboratory. The ability to import that data into an ELN can be beneficial, especially when an instrument can't be connected or external clients collaborating on a project need to submit relevant data. 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 ELN may allow for the importation of other application data in other formats, including XML data like in Agilent's OpenLAB ELN.[18]

Internal file or data linking

This feature allows research collaborators using an ELN to link together experiments, reports, protocols, results, and more, providing greater contextual clarity to projects. Examples include:

  • linking a sample batch to an experiment or sample preparation methodology
  • linking a test process to a particular experiment
  • linking a report to a sample batch
  • linking a group of experiment results to a raw data file
  • linking multiple images to a notebook entry
  • linking all experiment results with the correct reporting test methods

External file or data linking

This feature allows research collaborators using an ELN to link together data and files housed in the database with data, files, and customers outside the ELN's servers. Examples include:

  • linking to external research data sources hosted on the Internet[19]
  • linking external data sources with internal laboratory execution methods[20]
  • linking an ELN to an external LIMS or other laboratory informatics solution[21]

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.[22][23] The result today is some LIMS either include traditional ELN functionality or link physical laboratory notebook references to data in the LIMS.[24]

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.[25] 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.[26] Nevertheless, laboratories continue to use Excel in some fashion, and thus Excel integration or data exportation in Excel format is a real need for ELN customers. ELNs with this feature allow raw, processed, or imported data to be exported in the Excel format for further analysis and dissemination elsewhere in the ELN or externally from it.

Raw data management

While not described as a feature on most ELN vendor websites, a few indicate that their notebooks are capable of managing (import, export, editing, etc.) data in its raw format for future analysis and dissemination.

Data warehouse

An ELN's data warehouse serves the important function of storing, extracting, and managing the data that laboratories produce 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.[27]

Project and/or task management

Project and task management within an ELN typically involves the scheduling of tasks to researchers 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 ELNs 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
  • pending workload verification
  • project- and experiment-based workflow management
  • sample, batch, and document linking
  • work template sharing
  • recurring event management

See also: Experiment management

Experiment and/or trial management

Experiment and research management functionality is a vital component of most ELNs, and it can cover a wide variety of tasks, from notebook entries to task assignments. From designing an experiment to recording the results in the notebook, It's worth noting this functionality category may seem broad in scope and include other functionality listed on this page, including workflow management and project and task management. Its inclusion when reviewing software functionality is primarily to indicate when a vendor or project team indicates the existence of specific experiment management tools in their software.

Inventory management

ELNs can assist researchers not only allocate reagents to particular experiments or stations but also track available quantities for future experiments.
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, some ELN products now include limited or full-featured inventory management functionality, which may include the ability to:
  • register the origin and 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
  • track location and usage of reagents
  • assign storage locations
  • track forensic evidence

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

Document and/or image management

Standard operation procedures, (SOPs), specifications, reports, graphs, images, and receipts are all collected and used in the average laboratory. With an ELN already designed to reference and store experiment data of all types, it makes sense to include functionality to create, import, export, and manage other sorts of data files. As 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
  • add images and photos inline to a notebook entry
  • enforce version control
  • provide full text searches
  • export to PDF, XML, or other relevant formats
  • add documents as attachments

Patient and 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.[28]. 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 laboratory informatics products.
Workflow management is common in the laboratory, acting as a graphical representation of planned sequential steps to either automate or clarify a process or experiment within the lab. Separate standards-based workflow management systems (in the form of a software component) have traditionally performed this task.[29] However, in the 2000s vendors began incorporating workflow management functionality into their laboratory informatics software, reducing customization headaches in the process.[30]

Modern commercial and open-source ELN solutions often feature workflow management functionality, including[31][32][19][21]:

  • managing the request cycle within a laboratory
  • executing and review ELN workflow validations
  • managing specific chemistry- and biology-related procedures
  • creating and assigning unstructured experiment documentation
  • defining activity attributes
  • setting of quality control limits
  • dynamically modifying workflow in case of future changes
  • receiving notification of changes to the workflow

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[33], 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, supplier, and physician 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, equipment providers, and reagent suppliers. 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 experiments, 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 and revenue 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

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.

 

Regulatory compliance

The topic of whether or not an ELN meets regulatory compliance is often a complex one. While Title 21 CFR Part 11 has arguably had the largest influence on an electronic data management system's compliance, other influential standards have shaped the way laboratory informatics systems handle and store data.[34][35][21] Other compliance-based codes, standards, and regulations include:

With so many codes, standards, and regulations, ELN 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

The quality management functions of an ELN allow users to maintain a level of necessary quality across many of the functions in a laboratory. However, traditionally ELNs have been the domain of research and development (R&D) functions, in the process not giving much consideration to the needs of quality assurance and quality control (QA/QC) laboratories. Where R&D labs need flexibility and freedom, QA/QC labs require more structure in their ELN software.[36][37] Some vendors have created ELN modules or separate software solutions (like laboratory execution systems [LES]) to address the specific needs of QA/QC labs, while other vendors have simply included an ELN add-on to their LIMS.[38][39][40][41]

Performance evaluation

As document and file management plays an important role in electronic laboratory notebooks, it only makes sense to collate and store all the documentation associated with employee training and certification. Changes to laboratory techniques, scientific understanding, and business practices force researchers to learn, reevaluate, and demonstrate competency in order to maintain quality levels in the laboratory. Evaluations can frequently extend beyond staff members, however. Clinics, visit types, vendors, or test species can also be tracked and evaluated based on custom criteria. The performance evaluation functionality of a LIMS makes this possible.

That functionality typically includes the ability to maintain training records and history, and also to link that training to a technique or piece of equipment. Afterwards, the staff member, vendor, etc. can be marked as competent or certified in the equipment, knowledge, or process. Periodical assessment of the training and its practical effectiveness can later be performed. Productivity of an entity or process can also be gauged over a certain date range based on tracked time, pre-determined milestones, or some other criteria.

Audit trail

Whether validating an instrument's data or an entire ELN, maintaining an audit trail is an important part of 21 CFR Part 11 compliance.
As codes and regulations like Title 21 CFR Part 11 mandate "computer systems (including hardware and software), controls, and attendant documentation" utilize electronic signatures and audit trails[42], ELN developers must put serious thought into how their software handles audit trail functionality. The audit trail — documentation of the sequence of activities that have affected an action — must be thorough and seamlessly integrated into the software.


Information recorded in the audit trail typically includes:

  • operator code
  • time stamp
  • location
  • case number
  • transaction type
  • amount and quantity prior to change
  • user notes


Chain of custody

The chain of custody (COC) of an item is of varying importance, depending on the type of laboratory. A highly regulated laboratory that works under Code of Federal Regulation or other guidelines makes tracking COC a vital part of its operations. This is especially true in forensic labs, which depend on continuous accountability of their evidence collection, retention, and disposal procedures.[43] As with an audit trail, a laboratory depends on recorded information like user ID, time stamp, and location ID to maintain a robust and accurate COC. Barcodes, inventory management, and configurable security roles all play an important part in maintaining chain of custody.

Configurable roles and security

Many roles exist within the laboratory setting, each with its own set of responsibilities. And just as the role an individual plays within the laboratory may change, so may the responsibilities associated with each role. This sort of change necessitates a flexible and configurable security system, one that allows for the placement of individual ELN users into standardized security roles which provide role-specific access to certain functionality. Additionally, as responsibilities change within roles, that same flexible configuration is necessary for assigning or restricting access to specific functionality for each existing or newly created role.

Of course, roles aren't always assigned on an individual level. Often large groups of individuals may need to be assigned to roles, necessitating group assignments for security purposes. For example, a group of laboratory trainees may only be given read-only access to the experiment management functionality of the system through a custom "Trainees" group role, while the head researcher of the lab may be given the "Administrator" role, which allows that individual to access most if not all of the ELN's functionality.

Data normalization

For the purposes of describing ELN functionality, "data normalization" specifically refers to the process of ensuring incoming/imported data into the ELN is standardized to the same format of existing data.

Here's an example to better explain this issue. When an ELN is initially configured, in most if not all cases a clear standard can be set for how logged experiment results and their associated measurements pre- and post-analysis are recorded in the system. Perhaps all temperatures will be recorded in Celsius to three decimal places. If temperature data imported from a spreadsheet or a lab instrument is not in this format, the ELN can normalize the incoming data to match the standard already set for existing temperature data. This ensures consistency within the database and typically leads to better data validation efforts later on.

Note: Some ELN developers may include data normalization functionality within what they may refer to as data validation functionality. The line between these two may be blurred or not exist at all.

Data validation

For the purposes of describing ELN functionality, "data validation" specifically refers to the process of ensuring existing data in the LIMS — either pre-analysis or post-analysis — sufficiently meets any number of standards or thresholds set for any given data management process. This validation process may be completely automatic and system-based, or it may also include additional steps on the part of the user base utilizing additional ELN functionality, including verification of standard operating procedures (SOPs), QC samples, and QA approval.[44][45]

Note: This functionality shouldn't be confused with the process of validating the application itself, which is an entirely different process partially falling under regulatory compliance and involves the process of ensuring "the software is performing in a manner for which it was designed."[46]

Data encryption

In an ELN files can be encrypted and then read by only someone who has the specific key or rights to do so.
The existence of this functionality in an ELN generally indicates the software has the ability to protect the integrity and authenticity of its housed data through the use of a variety of technologies which makes data unreadable except to those possessing a key/right/etc. to unlock/read the data. This functionality is especially vital to the web-enabled ELN, which transfers information over the Internet in a client-server relationship. As a wide variety of encryption technologies exist, it's generally a good idea to consult with the developers of an ELN to determine the strengths and weaknesses of their employed encryption methods.

Version control

Version control is a form of safeguard which helps preserve data integrity and thus ties in with the topic of regulatory compliance. This is typically done by creating a modifiable new version of a piece of information rather than allowing the original to be modified. Such versioning may be applied to a wide variety of digital information housed in the ELN, including templates, training certifications, instrument logs, specifications, and process and procedure (P&P) documentation. Information tracked with such revisions includes attributes like user name, time the edit was made, and what exactly was edited. This also benefits those managing audit trails and chains of custody.

Other ELN vendors may employ a different form of version control called file locking, which simply puts the affected information into a read-only mode for users while someone else is busy editing it. Another popular strategy is to, rather than locking the file, allow multiple people to edit a piece of information, later merging the various edits. Potential ELN buyers may need to inquire with developers to determine what type of versioning scheme is used in the vendor's software.

Automatic data backup

The existence of this piece of functionality in an ELN usually means information contained in one or more associated databases or data warehouses can be automatically preserved in an additional backup file. The save location for that file as well as the scheduled backup time is configurable, typically through the administrative module of the ELN.

Environmental monitoring

Some LIMS like Core LIMS and Oracle Health Sciences LabPas allow users to monitor the environmental conditions of not only sample storage containers but also the entire laboratory itself.[47][48] Attributes like humidity, air quality, and temperature may be monitored to ensure sample storage units and experiments maintain desired conditions. Alarms may be able to be configured to notify staff if a storage container's environmental attributes go beyond a certain threshold. Manufacturers utilizing a LIMS like NOVA-LIMS may also be able to employ more advanced environmental tracking features in the plant to guarantee a more consistent, higher quality product is created.[49]

 

Reporting, barcoding, and printing

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.

 

Custom reporting

Reporting may not be as vital in an ELN as a LIMS, but it still is useful for gaining a clearer picture of collected data and potential trends. At a minimum, a number of pre-configured report templates typically come standard with an ELN. However, other systems are more flexible than others, offering the ability to customize reports in numerous ways. The most popular attributes of custom reporting include custom headers, custom information placement, charts, pivot tables, and multiple output formats.

Note: Some ELN vendors will offer custom reporting as an option as an added cost, depending on the level of customization required.

Synoptic reporting

Report printing

Today's software almost universally offers the ability to print reports and other materials, so this feature may seem a bit redundant to list. Nonetheless, printer support is a feature worth confirming when considering a piece of laboratory informatics software.

Label support

The label — typically affixed to a sample container or piece of equipment — is a vital part of many laboratory operations.[50] Identifying information such as sample number, batch number, and barcodes are printed on such labels to ensure optimize managing the location of items in a lab. As such, some ELNs allow users to design and print labels directly from the software.

The word "Wikipedia" encoded in Code 128 and Code 39

Barcode and/or RFID support

Barcodes offer many advantages to laboratory techs handling samples, including more accurate data input, tighter sample/instrument associations, tighter sample/study associations, and more room for human-readable information on a label.[50] Given such advantages, many laboratory informatics developers have integrated barcode support into their software, including support for symbologies like Code 128, Code 39, and Interleaved 2 of 5. Aside from printing options, an ELN may also offer support for a variety of barcode readers.

Barcode support and label support are typically found together in ELN software, but not always, thus their separation into two features.

Export to PDF

An ELN with this feature is able to collect and save information into a Portable Document Format (PDF).

Export to MS Word

An ELN with this feature is able to collect and save information into a Microsoft Office Word format.

Export to HTML or XML

An ELN with this feature is able to collect and save information into a HyperText Markup Language (HTML) and/or Extensible Markup Language (XML) format.

Fax integration

A LIMS with this feature is able to connect with a fax machine and send information to it via manual input, automatically, and/or at scheduled intervals.

Email integration

An ELN with this feature is able to integrate with and use the electronic mail information exchange method to send reports, alerts, and more manually, automatically, and/or at scheduled intervals.

 

Base functionality

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.

 

Administrator management

The administrator management tools of an ELN allow researchers to set up the ELN most optimally for the facility and its projects. Through the administrator management interface, other features may be accessed like setting up user roles and scheduling automatic data backups.

Like report printing, administrator management is nearly ubiquitous in laboratory informatics software, generally considered a mandatory feature. However, for the purposes of being thorough, it's important to point out its existence.

Modular

This feature indicates that an ELN has an intentional modular design, which separates some functionality into manageable components of the overall system. Generally speaking, a modular design allows for 1. the structured addition of new functionality to an ELN and 2. the limiting of overall effects on the system design as new functionality is added.

Instrument interfacing and management

An electron microscope could potentially be connected to an ELN via instrument interfacing.
In laboratories there are instruments, and with those instruments comes scientific measurements which produce data. It's therefor natural a researcher would want to connect those instruments to an electronic laboratory notebook, which is already organizing and storing laboratory data for projects and collaborations. This sort of interfacing is typically handled with instrument-to-software interfaces, which started out as merely data-transfer mechanisms. Later that interface mechanism became much more robust as a data management tool, though often at great expense with heavy involvement from third parties.[51] Today, "vendors can act as single source providers of the entire instrument interfacing solution,"[52], providing a cheaper and smoother solution to laboratory informatics customers.

It should be noted that some ELN vendors take the approach of creating ELN integration with a laboratory information management system (LIMS), letting the LIMS handle the instrument interfacing duties. Such functionality is not exclusive; an ELN may be able to interface both with laboratory instruments and with a LIMS. This built-in interface functionality is usually conducted with the help of a parsing engine, which helps translate machine data into a formatted and manipulable format, often customized by the ELN vendor.[53][54][55]

Mobile device integration

While not ubiquitous by any means, ELN developers are increasingly including support for mobile devices in their software, usually in the form of a separate mobile version of the software. Research and development labs potentially can put mobile technology to use in the laboratory as remotely monitoring a lab or using mobile phone microscopy.[56] Those uses aside, the relatively simple action of recording and reviewing laboratory research results while on the move or at a conference gives researchers flexibility, and ELN developers like Rescentris are beginning to include that functionality.[21] And where the options aren't simply appealing, some entities like the University of California – San Francisco are making their own mobile-friendly ELN application.[57]

Third-party software integration

Some ELN vendors either incorporate third-party software into their ELN (e.g. Agilent's integration of Surety's AbsoluteProof[58]) or they provide the means to integrate the ELN with other applications. Labtronics' Nexxis ELN is such an example, integrating with other laboratory informatics software, stats packages, and molecular drawing programs.[59] Other ELNs like Evolvus' Electronic Lab Notebook simply communicate with common authoring tools like Microsoft Word, allowing users to work directly from the third-party application and then transferring the information to the ELN.[60]

In some situations, a third-party application like Labtronics' LimsLink is simply used to integrate one piece of software with another piece of software or an instrument.

Alarms and/or alerts

Alarms and alerts in an ELN can be automatic or scheduled, and they can come in the form of an e-mail, a pop-up message, or a mobile text message. For example, when an experiment result goes out-of-range, an automatic warning message can appear on the screen of the research team responsible for the experiment. Another example: a scheduled alert can be e-mailed to a lab technician every month indicating a piece of laboratory equipment needs routine maintenance. Both scenarios represent a tiny fraction of the possible implementation of alarms and alerts in an ELN, highlighting how powerful (yet easy to take for granted) this feature is.

Work-related time tracking

This feature specifically refers to a LIMS' ability to track the amount of time an employee spends at work in general (for payroll purposes) or on more specific projects and tasks (as part of an employee work evaluation program).

Voice recognition system

A LIMS with this feature allows some functions of the LIMS (for example, accessing sample analysis results) to be accessed via voice commands.

External monitoring

This feature allows clients and/or collaborators outside the laboratory to monitor the status of experiments, test results, and more via an online web portal or, less commonly, as activity alerts sent via e-mail or SMS.

An instant messaging client built into an ELN often makes it easier to collaborate.

Messaging

The messaging feature of an ELN may refer to one of two (or both) things:

  • a built-in instant messaging system that allows users to converse with each other through text messages real-time
  • an SMS text messaging integration that allows the users or the ELN itself to send messages or alerts to one or more user's mobile or smart phone

Commenting

Research collaborations require data sharing and communication tools to be most effective. One of the collaborative communication features of an ELN is commenting. Many ELNs like BiochemLab Solutions' Electronic Lab Notebook and LabArchives, LLC's LabArchives ELN allow users to comment on experiment results, observations, and conjectures as well as allow for linking to and from comments.[61][62]

Multilingual

If an ELN is listed as multilingual, its an indication the software interface can be configured to display more than one language depending on the preference a user or administrator chooses. Some ELN interfaces can only be displayed in one of two languages (English or German, for example), while others come configured with support for dozens of languages.

Network-capable

This feature is perhaps archaic and/or obvious, but it is mentioned nonetheless. It's generally applied to a non-web-based ELN installed over a local or wide-area computer network, essentially indicating the ELN is not an isolated application, but rather one that can interface with other instances or other networked instruments.

Web client or portal

An ELN with a web client or portal is either a web-based ELN (one that is not installed on every computer, but rather is hosted on a server and accessed via a web browser) or a non-web-based ELN with an included portal to access it via the Internet.

Online or integrated help

This indicates an ELN has help infrastructure integrated into the software, support documentation via the vendor's website, or both.

Software as a service delivery model

This indicates the software can be licensed and utilized via the software as a service (SaaS) delivery model.

Usage-based cost

While rare, some software vendors allow potential clients to license and utilize the vendor's software under a usage-based cost model. An example of this model in use is Bytewize AB's O3 LimsXpress, which has a cost directly related to the amount of samples processed each month.[63]

 

References

  1. ↑ "Quick Start Guide to Laboratory Information System (LIS) Implementation" (PDF). Association of Public Health Laboratories. http://www.aphl.org/aphlprograms/global/initiatives/Documents/LISQuickStartGuide.pdf. Retrieved 27 April 2013. 
  2. ↑ Hice, Randy (1 July 2009). "Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications". STARLIMS' Laboratory Informatics Blog. http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/. Retrieved 27 April 2013. 
  3. ↑ "How Do I Find the Right LIMS — And How Much Will It Cost?" (PDF). Laboratory Informatics Institute, Inc. http://files.limstitute.com/share/lbgprofiles/findlims.pdf. Retrieved 27 April 2013. 
  4. ↑ "Laboratory Information Systems". Biohealthmatics.com. 10 August 2006. http://www.biohealthmatics.com/technologies/his/lis.aspx. Retrieved 27 April 2013. 
  5. ↑ 5.0 5.1 Leonard, Debra G. B.; Bagg, Adam, ed. (2007). Molecular Pathology in Clinical Practice (Illustrated ed.). Springer. p. 567. ISBN 0387332278. http://books.google.com/books?id=Z2YNhh51SmQC&pg=PA567. Retrieved 27 April 2013. 
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  7. ↑ Esteridge, Barbara H.; Reynolds, Anna P.; Walters, Norma J. (2000). Basic Medical Laboratory Techniques (4th, revised ed.). Cengage Learning. p. 8. ISBN 0766812065. http://books.google.com/books?id=qMgAbOHSlsMC&pg=PA8&lpg=PA8. Retrieved 27 April 2013. 
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  9. ↑ Muntean, Edwarda; Nicoleta Munteanb; Tania Mihăiescua; Radu Mihăiescuc (2008). "LIMS use in laboratory data management" (PDF). ProEnvironment/Promediu 1 (2): 19–23. http://journals.usamvcluj.ro/index.php/promediu/article/download/2835/2696. 
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  23. ↑ Elliot, Michael H. (October 2011). "Informatics Convergence Presents Opportunities and Challenges". Scientific Computing. http://www.scientificcomputing.com/articles-IN-Informatics-Convergence-Presents-Opportunities-and-Challenges-111111.aspx. Retrieved 25 February 2012. 
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  28. ↑ Hice, Randy (1 July 2009). "Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications". STARLIMS' Laboratory Informatics Blog. http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/. Retrieved 09 May 2011. 
  29. ↑ "Workflow Management Coalition Terminology & Glossary" (PDF). Workflow Management Coalition. February 1999. pp. 9. http://www.wfmc.org/standards/docs/TC-1011_term_glossary_v3.pdf. Retrieved 20 February 2012. 
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  31. ↑ Beato, Brian D.; Grever, Timothy P. ; Branstrator, Laurel E.. "Using Electronic Lab Notebook Functionality for Validating Electronic Lab Notebook Workflows" (PDF). AIT Bioscience. http://aitbioscience.com/wp-content/uploads/Using-Electronic-Lab-Notebook-Functionality-for-Validating-Electronic-Lab-Notebook-Workflows.pdf. Retrieved 12 February 2013. 
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  43. ↑ Jones, Andrew; Craig Valli (2008). "Chapter 1: An Introduction to Digital Forensics". Building a Digital Forensic Laboratory: Establishing and Managing a Successful Facility. Butterworth-Heinemann. pp. 11. ISBN 1856175103. http://books.google.com/books?id=F5IU7XXKwCQC. 
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  45. ↑ Hitchcock, Noel (2005). "Chapter 10: Efficient utilization of LIMS data and integration with mining process management systems". In Dessureault, Sean D.; Rajive Ganguli; Vladislav Kecojevic; Jami Girard Dwyer. Application of Computers and Operations Research in the Mineral Industry. Taylor & Francis. pp. 85–88. doi:10.1201/9781439833407.ch10. ISBN 9780415374491. http://www.crcnetbase.com/doi/abs/10.1201/9781439833407.ch10. 
  46. ↑ Turner, Elizabeth; Jojean Bolton (2001). "Required steps for the validation of a Laboratory Information Management System". Quality Assurance 9 (3–4): 217–224. PMID 12553085. http://www.ncbi.nlm.nih.gov/pubmed/12553085. 
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  51. ↑ Pavlis, Robert (May/June 2004). "Trends in instrument-to-LIMS interfacing". Scientific Computing World. http://www.scientific-computing.com/features/feature.php?feature_id=88. Retrieved 8 May 2012. 
  52. ↑ DeHeer, Larry (1 October 2009). "Instrument Interfacing - The Great Paradox of LIMS?". LIMSfinder.com. http://www.limsfinder.com/BlogDetail.aspx?id=33851_0_2_0_C. Retrieved 8 May 2012. 
  53. ↑ "AGARAM: LogiLab ELN". Agaram Instruments (P) Ltd. http://www.agaram.co.in/n/index.php/products/logilab.html. Retrieved 16 April 2013. 
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  58. ↑ "Nexxis ELN 5.0". Scientific Computing World. 12 May 2010. http://www.scientific-computing.com/products/product_details.php?product_id=835. Retrieved 13 February 2013. 
  59. ↑ "Electronic Lab Notebook". Evolvus Pvt. Ltd. http://www.evolvus.com/Informatics/ElectronicLabNotebook.html. Retrieved 13 February 2013. 
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  61. ↑ "LabArchives Online Lab Notebook - Features & Benefits". LabArchives, LLC. http://www.labarchives.com/features.php. Retrieved 13 February 2013. 
  62. ↑ "Modern web based Lims from 10 Euro cent/sample". Bytewize AB. http://www.bytewize.com/o3lims-xpress/prices/?lang=en. Retrieved 8 May 2012. 
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