Usually known as LIMS (LABORATORY INFORMATION MANAGEMENT SYTEM), it is a group of methods and tools based on computing, used by laboratories to administer or manage their data and disperse the results in specific areas.
Knowing that the main asset of any laboratory, that fulfills any purpose, in any industry, is neither more nor less than information, a LIMS should help us:
- manage the processes and way of working defined within the Laboratory.
- manage the data and information generated by the laboratory.
- comply with the Laboratory’s Regulatory and Quality requirements.
Laboratories constitute a fundamental area within the organization, they function as a business in themselves, they have their own clients, suppliers, budget, products, etc., and therefore require their own system. They are also subject to the same or greater pressures than the rest of the areas or companies to which they provide services, whether due to increased demand, increased expectations, supporting the dizzying advance of technology, working with tight budgets and developing their tasks efficiently and effectively. Therefore, a LIMS must help the laboratory resolve all these pressures by improving functionality, quality, costs, resource utilization and the value that the laboratory represents for the rest of the organization.
Some of the most important reasons to implement a LIMS are:
- Avoid typing and data transcription errors – Direct acquisition from the instruments
- Respond quickly, ensuring the quality of the results.
- Control the quality of raw materials before they are used by production plants.
- Automate chemical formula calculations
- Automatically validate results
- Generate and distribute multiple reports
- Comply with regulations
- Manage information
- Reduce the number of possible errors
- Quickly record samples
- Information security and control
Although the justification for acquiring a LIMS seems simple and inevitable, given that its benefits are obvious and intuitive, it is generally required to clearly justify that it is not an expense but an investment, thus compromising the economic and human resources for an implementation. successful.
Now, there are many and diverse offers on the market and of different scope, technology and features, as well as the permanent debate about the convenience between developing a system or acquiring a product, which is the subject of another discussion. In any case, we should require our solution to meet at least the following requirements:
- That it is flexible, that is, that it can be absolutely and totally configurable by the users, without having to resort to the supplier or developer in the event of any change or new requirement.
- That it is auditable, guaranteeing traceability, that all records are subject to audit, and that it complies with the regulations that apply to each company or industry (ISO, FDA, GLP, GMP, etc.)
- That it is collaborative, allowing it to be very easily connected to the laboratory instruments, and integrated with the rest of the systems in force in the organization, as well as with all the utilities and office tools.
- That it is “future-proof”, allowing it to be scalable and adaptable to new versions not only of the system itself, but also with regard to updating operating systems, database engines and interfaces with other systems, thus avoiding more efforts and new re-investments.
A LIMS should be able to offer adequate solutions to Research and Development laboratories, Analytical laboratories, Process laboratories, and a combination of all of them, given that in many cases organizations require all of these specializations simultaneously. Among the different types of laboratories are:
- Laboratory Quality Control Manufacturing
- Oil and Gas
- Chemicals and Petrochemicals
- General Manufacturing
- Food and Drinks
- Water supply and Treatment
- Laboratory Service and/or Analytical Contracts
- Enviromental Analysis Laboratories
- General Analytical Service Laboratories
- Goverment / Public Healt
- Forensic Laboratories
- Criminal Investigation Department
- National Forensic Services
- Clinical Laboratorie
- Molecular Diagnosis
- Biobanks y Biorepositories
- Research Laboratories
- Clinical R&D
- Hospital Clínical Laboratories
- Usually called LIS (Laboratory Information Systems)
- Centered around the concept “Patient”
INTEGRATED SOLUTIONS AND INFORMATION INTEGRITY
This is a fundamental aspect for laboratory data management. It is always convenient to be able to integrate all the necessary functionality in a single tool. The dispersion of solutions and therefore also of suppliers, generates great difficulties when trying to integrate all the information safely and efficiently. Nowadays, it is no longer enough to have a LIMS, but other related and integrally linked tools are also required.
Connectivity and bi-directional interface with instruments and equipment
Within the constant evolution of technology, we must now think about a bi-directional integration with laboratory instruments. In this way, the analysts’ task is optimized, sending the samples and the work list, and receiving the results from the instruments
The adopted solution should be able to operate with structured and unstructured data, but also allow the control of “all” instruments from a single application, as well as access to all historical meta data, audit logs and all data “raw” delivered by laboratory instruments
Another great advantage that today offers is the so-called Technological Cloud. There are different ways to use and benefit from this new modality, allowing laboratories to minimize costs and investments, and being able to operate under different alternatives, such as:
– IAAS – Infrastructure as a Service
– PAAS – Platform as a Service
Operating System / Programming Language / Database
– SAAS -Software as a Service
The complete computing solution, without hardware or software installation
(just as Gmail / Facebook / Twitter works today)
Some of the advantages of operating within the technological cloud.
- It allows you to save large costs in equipment, maintenance, specialized personnel, physical space, backup copies and server updates.
- It allows you to save on licenses, installations, system monitoring, database maintenance, version updates, malware/virus protection, and environment configuration.
- It allows you to install your application systems in the cloud, knowing that some providers offer this service as system rental or use services on their own servers, without requiring purchase or acquisition.
- To correctly size the convenience and viability of installing or migrating your systems and applications to the cloud, you should consider:
– Whether you will connect to a public or private cloud
– Number of environments (production, development, test, etc.)
– Number of users and attendance by shifts or schedules
– Number of samples processed per day.
– Quantity and type of laboratory instruments and their interfaces.
– From what geographical locations you intend to access.
– Volume of backup information and retention requirements.
– If you require compliance with regulatory requirements for data encryption in transit in accordance with HIPAA (Health Insurance Portability and Accountability)
It is of utmost importance to clearly establish the necessary functionality for each laboratory and each organization. Some are common and transversal to all of them and others are specific depending on each case. But it is important to ensure that the implemented solution will consider at least the following.
- Parameterization: Initial configuration of all required static and dynamic tables, for eventual or one-time updating by system administrators, where the laboratory master data is defined.
- User Management: Identification of all system users, with their roles, security, access permissions, status, job description, and enabled laboratories or services.
- Laboratory Organization: Hierarchical organization of areas and sectors, including definition of teams or service groups, with the personnel assigned in each case.
- Administration, Handling and Management of Equipment and Instruments: Identification of each instrument, components, general characteristics, calibrations, verifications, maintenance, tests, standards, assigned workload lists, scheduled tasks and data capture methods.
- Environmental Monitoring: Allows you to monitor the production environment in which batches or sample requests are created and be able to graphically visualize the various sampling points designated to track environmental variables.
- Determination of Sampling Points: Determine, schedule and assign frequency for sampling according to the different analysis and testing needs.
- Client Management and Administration: Administration of internal or external clients, contracts, contacts, tests, samples of each project, results, specifications, meetings, interviews, billing, price lists, quotes and prices.
- Management and Administration of Human Resources: Registration of laboratory personnel, electronic invitation to training courses, training calendar, certifications obtained, skills for carrying out tasks.
- Management and Administration of Materials and Reagents: Administration of materials, with their properties, recipes, safety instructions, storage management and control, deposits, attachments and danger alerts, supplier management, purchase orders, consumption and automatic discount of materials used , determination of minimum stock.
- Test Administration: Manage the list of tests with their respective analyses, including calculations, limit detection, specifications and assignments, properties and methods.
Sampling Plan Administration: Determine for each analysis its validations and specifications, data type, ranges, and acceptable parameters.
- Chain of Custody: Ability to locate or dispose of samples and conservation containers
- Method Administration: Operation with standards and methods managed by the laboratory, version control, change history, printouts and visualizations of all documentation.
- Document Management and Version Control: Document management must be integrated into the system and have strict version control, controlled copies, with their authors, approvals and respective dates.
- Automatic Calculations: Allow all types of calculations and functions using the values entered or received from the instruments and operate them with existing data in the laboratory files.
- Stability Studies: Manage the handling of products that can be maintained according to different storage conditions. Consider different time intervals, analyze behaviors and specifications.
- Planning for sampling and analysis: The entry of samples or batches of samples into the system should be carried out using various methods.
- Traceability: In each sample it must be possible to observe the certifications of the analysts, registration and calibration of the instruments used, details and changes of each sample, and the electronic signatures aligned and in compliance with ISO 17025 standards.
- Calendar and Work Planning: Agendas with automatic alerts with all laboratory activities for each user and analyst.
- Workflow Designer: Workflows must be able to be designed for any type of information, with consistent visibility for the format and report designer.
- Online audits: Enable, according to the permissions and attributes of each user, to be able to view all the operations carried out within the laboratory, with all the available information.
- Report Designer: Allow in a simple and clear way the creation of different types of visualizations and information outputs, suitable for any type of user without computer knowledge, with different types of formats and graphics, and exportable to other systems or external tools.
- SQC Control: Determine control charts with different graphs, means, derivatives, standard deviation, capacity, trend curves, and all of this configurable by users.
The LIMS must facilitate routine laboratory operations, guiding and collaborating with analysts in an agile and dynamic way, avoiding errors and automatically directing work throughout the entire life cycle of the samples.
- Sample Registration: Make test requests and work assignment based on previously configured criteria. There should be different methods for sample registration (batch, routine, time-scheduled, event-based, calendar, ad hoc, etc.)
- Pre-registered Samples: It is very efficient to have the ability to pre-register samples, preparing to process the samples when they physically arrive at the laboratory, avoiding possible manual loading errors. The capture can be done via the web by the client, interface from other systems, mobile devices, etc.
- Reception in the Laboratory: It is convenient to receive and enter samples using barcodes, manual reading devices, to do so quickly and without errors.
- Work Assignment: Depending on the specific business rules of the laboratory, tasks must be assigned to analysts and teams. They should be able to be assigned manually or automatically according to previous parameterizations.
- Results Entry: Results must be able to be entered manually or through automatic data capture through interface with laboratory instruments.
- Review and Approvals: According to the user profiles, pending results can be reviewed and approved, with electronic signatures before their final issuance, leaving audit trails and traceability.
- Protocols and Certificates of Analysis: In each sample it must be possible to observe the analysts’ certifications, registration and calibration of instruments, details and changes of each sample and electronic signatures.
- Editing Samples and Results: The system must provide tools for editing folders, batches and runs with their results, details of each sample, change control and traceability.
- Reports, Lists, Graphs and Statistics: Access must be allowed to all historical activities carried out by the laboratory and reports and lists, graphs, printed or electronic statistics must be issued
How to select and implement a LIMS?
We have briefly analyzed some of the most important guidelines to keep in mind when facing this decision. It is also more than clear that the only way to manage a laboratory efficiently and effectively is through reliable and secure IT tools. The first step should consider one of the fundamental premises of the “Validation of Computer Systems”, which is the preparation of the User requirements. One of the main reasons for decision failure is when it is not clear what we need, how we need it and why we need it. This reality often forces us to redefine and resize the project, with the usual delays in implementation and increased costs.
It is also very important to plan the growth of the laboratory in the future. A LIMS is a solution and an investment, not simply a “system”, therefore we must think about solving not only our current problems, but also the future ones. Generally, an attempt is made to implement a temporary or incomplete solution until “the time comes” to address a robust and comprehensive application, but this still requires a strong investment and an enormous dedication of time from all staff. In these cases it is very common to see these laboratories evaluating new alternatives in the short term, given that the installed solution no longer accompanies them, having lost a lot of time and a lot of money, added to an important political and opportunity “cost.”
In short, it is a very complex solution, highly regulated and integrated with multiple “third parties”, such as systems, office tools, laboratory instruments and other utilities. Raising the possibility of a development is feasible, but its implementation normally takes too long, and requires a large number of highly trained professionals in many and diverse disciplines to resolve it successfully. The serious problem here is that once implemented, a “new project” begins, and perhaps even more important than the first, which is the maintenance and evolution of the implemented system over time and the new requirements that the organization demands. individual and the market in general.
Currently there is a global trend towards the acquisition of “configurable solutions”, not only in the field of laboratories, but also in all industries that require software as a fundamental platform for their activities. The best way to ensure the success of a project of this magnitude is to analyze what the market offers in this matter. It is advisable to evaluate these companies based on their track record, market presence and customer references. It is always convenient to know in which and how many companies the evaluated solution is installed and of course in which laboratories in our own field it has been implemented. It is also advisable to request and demand references, within the local or international scope, not only to analyze the robustness of the product but also to analyze and talk with users and project managers about the implementation process. It is very important to ensure that the supplier will have and have suitable personnel to accompany the laboratory in its implementation project with some guarantee of success.
By Marcelo Cabezón, Graduate in Systems, Operational Researcher and Scientific at Ampersand Sistemas
Graduate in Systems, Operational Researcher and Scientific Calculator graduated from the Center for Higher Studies in Exact Sciences of the City of Buenos Aires – Argentina.
In charge of Ampersand Sistemas since 1990, specialized in Consulting and Development of Computer Projects.
Consultant and Auditor of ISO 9001 Standards, Computing Applied to Laboratories and Software Validation. Focused for more than fifteen years on issues related to Software Quality and implementation of IT Solutions.
Experience as a Trainer/Instructor in various topics related to Quality and Applied Computing in many Latin American countries.