Lims

LIMS In the typical scientific laboratory there is a large amount of data that must be tracked and analysed. In my current work setting we collect data from outside laboratories, analyse the data, and then return the data. We process thousands of samples per week. This makes tracking and sorting the data very cumbersome. We basically serve as a clearinghouse for data to be batched out to our customers, the independent researcher. Our laboratory considers itself a high-throughput sequencing centre. Our daily objective is to make the lab more automated. We are continually striving to use more robots or automated data entry.For automated data entry we use bar codes. Bar coding tends to have fewer errors in data entry. It also allows us to generate a greater amount of information for any given sample. The more we can automate the process the more samples we are able to put through the system. Each of the independent researchers in the company is looking for a particular disease by identi fying the disease-causing gene. Once the gene has been located the researcher must get the DNA sequence from the gene. That is our job. We at the sequencing centre take the DNA sample, with the gene, and run the sample on our automated machines.Once the sample has been analysed we put the analysed sample, also known as the DNA sequence, into a database that the researcher can access. This is a very general idea of what the Sequencing Centre does. The role of the Laboratory Information Management System (LIMS) is to keep track of this data. The accuracy of the LIMS is crucial for an efficient and effective workflow. The analysed sample must be coordinated with the correct sample name that the researcher gives to the Sequencing Centre. This means that everything must be entered into the database correctly. The data must also exist in a safe and accessible database.The data flow can be characterized in the following context diagram. We have just begun the implementation of a new LIMS s ystem. Hopefully this analysis will help to guide our laboratory as we move towards its implementation. LIMS Functionality Different LIMS systems offer a variety of functionality. The systems have developed from simple data entry and record storage to complex relational database driven tools. They now offer enhanced functionality often provided over the wireless networks and company intranet, allowing greater flexibility for inspections in remote and difficult environments Regulations and ComplianceThe functionality of the LIMS system is far greater than just tracking and reporting on samples. LIMS systems must often comply with regulations that affect the user, for example a manufacturer of pharmaceuticals is obliged to operate under the cGMP 21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs. Other regulations that LIMS systems must operate under include HIPAA, ISO 9001, and ISO 15189. It is important for systems to have the ability to accept e-signatures, as well as offer audit trails and chain of custody.These types of functionality are required to ensure that the correct persons have access to the sample and the results of the sample inspection Equipment Calibration and Maintenance When inspections are carried out the equipment used to extract the sample and to test the sample must be maintained correctly and calibrated so that there are no errors introduced into the test results. The LIMS system should contain maintenance records of the equipment used in testing so that notifications can be generated to perform regular preventive maintenance.With some instruments and equipment, the requirement may include calibration after a certain number of uses, for example the use of a depth micrometre may require that it is calibrated after 50 uses or every month, whichever comes first. LIMS systems can also contain the calibration instructions so that a notification and a calibration instruction s heet can be sent to the maintenance department or a specialty outside vendor. LIMS Expansion Pre-1982 Laboratory notebooks and handwritten reports/charts were used to track and report information.In-house information systems were configured by a few laboratories. Custom-built LIMS became available from third-party vendors. 1982 The first commercial LIMS, known as first generation (1G) LIMS, are introduced. These 1G LIMS placed laboratory functions onto a single minicomputer, providing greater lab productivity and functionality as well as the first automated reporting capabilities. 1988 Second generation (2G) LIMS become available. 2G LIMS used the available market technology of third-party commercial relational databases (RDB) to provide application-specific solutions.Most 2G LIMS relied on minicomputers, but PC-based solutions were beginning to emerge. 1991 The move toward open systems ushered in third generation (3G) LIMS, which combined the PC's easy to use interface and standard ized desktop tools with the power and security of minicomputer servers in a client/server configuration. 1995 Fourth generation (4G) LIMS decentralize the architecture further. Processing can be performed anywhere on the network. Thus, all clients and servers can operate in either capacity depending upon the data load at any particular instance Pros and ConsMost LIMS products allow the laboratory to; register work requests; print analytical worksheets; monitor and communicate sample/technique backlogs; schedule work; acquire and store analytical data; monitor the quality of all analytical work; approve analytical data for client release; print and store analytical reports and invoices; protect the security of all data; track and locate samples in storage; track and communicate all quality control in the laboratory; provide laboratory management with production and financial statistics and with client information, e. . , names, addresses, sales figures, etc. An appropriately designed and installed LIMS can quickly bring accuracy and accessibility to the flow of samples and data in any laboratory. The real value of a LIMS is the ability to maximize sample throughput and minimize labour costs. Laboratory throughput is improved in a number of different ways. The most obvious gain in productivity occurs through the elimination of data entry via on-line instruments. Also, there will be a significant decrease in data entry errors.Finally, the up-to-date sample in-flow data available from a typical LIMS allows laboratory supervisors and bench personnel to better schedule analytical work, minimize â€Å"downtime† and maximize batch size. Some other effects are that there are better visible quality control checks and centralized data. The ability to monitor, track and communicate data and quality control information gives the laboratory the tools to improve methods and work practices. The end result is that people in the lab able to process more samples per hour worked. The problems Rushed or Incomplete InstallationLIMS installation can be expensive. As a result laboratory management has a tendency to reduce costs by shortening the time spent on-site by the design team. In addition, several installation phases may be required in order to allow laboratory personnel time to learn and apply each LIMS feature before adding the next. Effective communication between the bench personnel and the design team is key to ensuring a successful project. The best way to facilitate this communication is by extending and phasing the installation. Lack of Technician Access to the LIMSA problem that arises in some organizations as laboratory and support staff begin to use the system is a failure to recognize and remove access bottlenecks. For a LIMS to function smoothly all personnel must have their own access point. Access expansion can usually be spread over six to eighteen months as the laboratory assimilates the LIMS and usage increases. Design/Scoping Pr ocedure The design/scoping stage prior to acquiring our LIMS has involved the review and analysis of available software/hardware packages as well as the definition and documentation of our laboratory’s requirements.The error here is could be that bench personnel are excluded from the process. To resolve this problem we have had frequent meetings with the personnel in our lab. Some laboratories might go into a LIMS program believing that future requirements for bench level supervision will be reduced or eliminated. It has been recognized by many that LIMS is simply a tool and as such cannot manage the laboratory or take the place of personnel supervision. A LIMS will effectively provide current, reliable and complete operational data.The easy access to accurate data allows management to significantly enhance the quality and speed of decision making. Decision making becomes based more on fact rather than instincts. Many LIMS products tend to function more like accounting or fin ancial databases. This could be related to the educational and work experience of most software professionals. The demand for financial and accounting database packages means that the software industry is more familiar with this type of requirement than with a highly technical application like a LIMS.Thus, the average software professional does not usually have the background to effectively interpret a laboratory’s requirements. This communication problem can manifest itself in LIMS systems that do not easily fit into laboratory operations. Often the laboratory must significantly alter procedures and work flow in order to conform to the LIMS. This requirement for wholesale change significantly complicates LIMS installations and it might have poor acceptance and commitment support personnel to the project. A similar problem often occurs in large organizations with dedicated Information System (IS), departments.Significant conflict and problems can arise when IS personnel recom mend the most up-to-date hardware or software architecture regardless of the functionality, fit or overall cost to the laboratory. The end result of this process is that the laboratory must undergo significant change in order to conform to the product purchased. In the extreme case laboratories can wind-up having to increase overhead, e. g. , more data handling, in order to use LIMS systems that have been designed not for the laboratory but for the accounting or production departments.The keys to success are flexibility, adaptability, ease of evolution and support, and most importantly overall system speed. The speed issue is very critical as bench personnel will not use something that is slow or awkward. If the system saves bench personnel time they will quickly â€Å"buy into† the project and aggressively move the process forward. The key in any LIMS development should be to achieve a majority of the desired functionality without compromising system speed. Most laboratories need time to assimilate a LIMS before being able to take full advantage of all of its features.As a result of this ‘break-in period’ the more complex features can usually be postponed a year or two without affecting the success of the program. [17] This implementation delay may also allow laboratory personnel the chance to provide more input into the critical final stages of system optimization. Installation Stage The goal of any LIMS installation must be to acquire a system that will make the jobs of bench personnel easier and thus increase the efficiency of the organization. In order to be successful, the LIMS system must be accepted and welcomed by the bench personnel.Often the first contact front-line personnel have with the new system is during installation, long after all decisions have been made. This situation often leads to significant software and LIMS configuration problems that require major software re-writes, hardware retro-fits and/or disruptive organiza tional changes. In addition, analytical and support staff are more likely to resist the new system if they have had little input into its design and operational characteristics. The installation phase of a LIMS program is critical to the overall success of the project.It is during LIMS installation that personnel must be taught how to use the product and where the software designers get their first view of how the LIMS will fit into and function in the laboratory. The installation phase of a LIMS project can take from weeks to months depending on the size of the laboratory and the complexity of the project. No Staff Training Bench personnel must be taught how to use the LIMS. As with any subject laboratory staff must be taught progressively so that personnel have a chance to use and apply what they learn.In laboratories where the LIMS training has been available and sustained the staff will be using the LIMS at a similar level. This consistency of approach builds team work and staff efficiency increases. In laboratories where training has not been a priority, staff will be using the LIMS at different levels. This situation can create a great deal of competition in the laboratory as turf wars erupt over the adoption of new or unused LIMS features. Poorly trained staff fears the new features and as a result delay or resist their implementation.Poor Feedback Mechanism As noted above communication is a key component of any successful LIMS project. It is important that laboratories make sure that a well-developed feedback mechanism is put in place during the installation of a LIMS so that laboratory personnel can bring forward problems and see quick resolution. Staff often hesitate to bring forward complaints and will instead work around the problem. One successful approach that has been used by organizations to solve this problem has been regular procedural audits.The process required to perform an audit usually brings to light LIMS defects or problems that staff have been coping with. This is has already been implemented for other laboratory procedures in our lab. Conclusion Companies require that quality is part of every link in the supply chain, whether it is raw material at a vendor’s facility or finished goods delivered to a customer. To ensure that the quality personnel are able to achieve the optimum results, a Laboratory Information Management System is vital to that success.