Quality is such an important part of the supply chain that manufacturing companies implements information systems specifically for the laboratories that perform the Quality inspections on finished goods and in-process materials.
The Laboratory Information Management System (LIMS) is an information system that can schedule testing, track tests and pass test results to other systems in the supply chain, such as an Enterprise Resource Planning (ERP) system.
The LIMS system is used primarily as a reporting tool where users can enter information about a test sample, such as inspection number, batch number, date, time, location etc. The LIMS system holds the details of the sample and the information which is pertaining to the sample. As the sample moves through the testing process, LIMS system can be updated so that users can track the sample. The sample can be tracked by entering the sample number into the system, entering the location or by using barcodes. When a sample is initially entered into the system, LIMS can print a barcode label with the unique sample number.
Different LIMS systems offer a variety of functionality. The system is being 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 which allows greater flexibility for inspections in remote and difficult environments.
The functionality of 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 cGMP21CFRPart210: Current Good manufacturing practices i.e., Processing, Packing, or holding of Drugs and 21CFR Part 211: Current Good Manufacturing Practice for finished pharmaceuticals. Other regulations that LIMS system must 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 a right person has access to the sample and the results of the sample inspection.
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 in 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 micrometer may require calibration on every 50 uses or every month or whichever comes first. LIMS systems can also contain the calibration instructions so that a notification and a calibration instruction sheet can be sent to the maintenance department or a specialty outside vendor.
A LIMS system should contain and manage the processes, procedures and methodologies that can be used to perform the test required at the plant. The system should provide a single repository for these methodologies and be able to select the correct method for the tests that are to be performed.
Companies require quality, that 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.
Optimizing your supply chain means that you are delivering your customer’s requirement at a reasonable cost. A robust LIMS will help us on keeping the quality up and drive optimization.
The first step in executing any laboratory informatics system (not limited to a LIMS or ELN) is to gain a knowledge of understanding the processes that comprises the laboratory operations. This is especially true for LIMS systems, because they often serve as the operational backbone of the lab. A complete understanding of laboratory business processes is essential to select the right LIMS vendor and to plan the implementation. Once the laboratory processes are understood, the next steps are to define and prioritize key requirements. Because they are the basis for evaluating and selecting the LIMS platform and ultimately, determining how much customization is needed, the requirements specification process should begin as early as possible.
Though the justification for a LIMS solution may be obvious to the laboratory R&D staff, it is still critical to build the business case with a positive ROI. The bottom line facts are always harder to dispute than opinions. Building a comprehensive business case will help to justify the acquisition of the LIMS and a good one will present tangible business benefits based on defined requirements and key performance metrics. Most organizations require a business case demonstrating a positive ROI before resources and funds are committed to a project. Depending on the project, the scope and complexity of many LIMS implementations will demand a business case that addresses the concerns and needs of all of the project’s stakeholders. A business case that anticipates potential problems or objections can also be a powerful tool to sell the project in the organization. Involving key stakeholders in the development of a business case can also be a strong way to build organizational support for the new system. A compelling business case will assess current system performance against expected post-implementation performance.
Establishing key performance indicators (KPIs) allow quantifiable measurement of progress during implementation and ensure a tie to real changes in performance. These metrics can also be used to evaluate LIMS software vendors and select which software modules best suit the user requirements. The issue of whether customization is necessary to satisfy a new user requirement is often raised during the implementation process. A business case with a positive ROI allows the merits of customization to be considered on the same basis as the original implementation. Investments in customization can be evaluated according to whether they fit the requirements defined in the business case, based on performance metrics that are quantifiable, rather than subjective measures.
Another characteristic that distinguishes best-in-class LIMS implementations is how well the implementation is managed. A prerequisite for a successful LIMS implementation is a dedicated project manager who is involved in both the planning and ongoing management of the effort. In addition, the company must also be willing to commit sufficient resources to the project before, during and after implementation. And it’s equally important to have the right mix of internal and external resources. Organizations often focus too much on whether the LIMS implementation resources are internal or external to the company. The trick is to augment your internal resources with the right external resources, with a proper LIMS expertise. Ideally, you need to have external resources that have performed numerous LIMS implementations before, preferably with your platform of interest. Strong project controls and governance are also needed to implement LIMS. A formal risk management and mitigation plan should be developed in advance, which should include ongoing reviews of project phases throughout implementation, with full participation of all inside and outside resources. A combination of project management skills, resources, and methodologies are vital to a successful LIMS implementation.
A distinguishing trait of best-in-class LIMS implementation is that they have full support and commitment of the company’s executives. In fact, it can be argued that this characteristic is the most important one for a successful LIMS implementation; without this support, LIMS initiatives are more likely to be starved for funds and resources. LIMS initiatives often begin with the IT director or manager, but the support of the CIO, CFO and other C-level executives is critical. These people are responsible for setting corporate business strategy and direction, so they should be making higher-level decisions about how the LIMS system will be involved in running the business. Depending on the breadth of the system, LIMS implementations can also cause changes in familiar workflows for people throughout the organization, whether they are directly involved in the implementation or not. For this reason, it is important to gain broad organizational support during all phases of LIMS implementation. Finally, the establishment of regular project reviews with the executive team or the project steering committee will keep them informed about project progress. It will also provide a forum so that the appropriate decision makers can deal with issues that arise.
In any LIMS implementation, there is no substitute for careful planning. In fact, planning should begin during the earliest project phases. Companies get excited about the benefits of implementing LIMS and tend to dive in without a fully developed plan. Too often, companies do not put the time in to produce a solid project plan upfront. The project plan should have time built into it for activities associated with requirements definition, key performance measures, vendor evaluation and selection. The best plans have buffers built into the schedule to account for activities such as testing, data migration and unforeseen events that occur in every implementation. Companies that invest in comprehensive, upfront planning often experience shorter implementation times and spend less money overall than their peers.
Focus on data migration early in the implementation process. Many companies tend to focus on software testing and configuration, keeping data migration until late in the implementation process. An attribute of successful LIMS implementations is that data migration is put into the project plan as early as possible. A company’s data is one of its primary assets and issues with migrating data between legacy systems and a new LIMS system can have a sizeable negative impact on laboratory operations, especially when those issues occur late in the LIMS implementation process.