How to deploy a LIMS
by: Raffaele Patruno – CSV/CSA & Data Integrity SME, Laboratory Manager & Associate Partner @ PQE Group
What is a LIMS
A Laboratory Information Management System, LIMS hereinafter, is a software that allows the definition, management and monitoring of the processes in the laboratory area. It allows to monitor the progression of the sample through its lifecycle (sample collection, receipt, results entry, final release, retain etc…) providing full traceability of the executed operations and enforcing the execution of activities in compliance with regulations and defined procedures.
Why implement a LIMS
The number of data produced in a laboratory has been continuously increasing over the years. The implementation of a LIMS software allows to have a single information repository facilitating:
- The harmonization of processes within different laboratories entities (i.e. microbiological vs chemical laboratories or different sites laboratory area) through the definition of standard workflows
- The review of generated data for regulatory and not regulatory purposes, including, but not limited to, trending and certificates generation
- A reduction in paper use and a decreased need for physical archives
- The automatization of the operations that connects LIMS with ERP, MES, QMS, analytical instruments etc…
- Operations into the laboratories by reducing manual errors, with a significant increase in efficiency
- The reach of the compliance with applicable regulations (i.e. FDA 21 CFR part 11, ISO17025, GxP etc…)
- The removal of other obsolete tools such as spreadsheet
It seems, looking at the list above, that the implementation of a LIMS solution can solve many of the actual laboratory problems, but if its implementation is not adequately planned and defined, it can’t provide the outputs and the outcomes expected. That’s why it is very important to scrupulously plan the deployment activities, passing through the high-level steps identified in the next paragraph.
How to implement a LIMS
1) High Level requirements and Vendor Selection
The first step of an efficient deployment process is the requirements definition. It is extremely important to identify which are the real laboratory needs in order to facilitate all the next deployment steps, starting from the vendor selection, passing through a clear definition of new software expectations up to the final release and LIMS utilization.
After the requirements definition, it is necessary to pass through a well done vendor selection to identify the proper vendor that can appropriately support the business. The vendor selection is often underestimated and considered a time-consuming activity, however this task appears to be crucial for the overall success of the project and to avoid implementation delays.
While considering a potential vendors, there are some aspects that should always be taken into account before the final decision, as an example: the possibility to apply changes to the standard processes and functionalities, maintenance and vendor support, expected number of users, minimum performances.
2) Detailed Requirements and Processes evaluation
The second step consists in a deeper analysis; it is required to detail the specific laboratory needs and to evaluate, with the selected vendor support, the discrepancies between the chosen vendor/software and the laboratory requirements. Each discrepancy should be carefully evaluated in order to find the best compromise between the processes proposed by the vendor and a fully customized solution.
A LIMS implementation is a good opportunity to revise all the processes and workflows in the laboratory, to make them compliant with the latest international and most efficient standards and best practices. Additionally, a LIMS software works per processes and not per area (as many companies do), this kind of perspective could enable or facilitate an optimization or harmonization of the existing processes.
In the case of an implementation of a new LIMS solution where a previous LIMS system already existed, imagining a huge number of customizations to have the new system to work exactly as the previous one is not the best solution. In addition to the clear financial implications of a significant vendor functionalities re-work, it is to be considered that this re-work process is going to strongly limit the possibility to improve the existing processes.
Instead, talking about a first LIMS implementation it is recommended to identify the Minimum Viable Product (MVP), the minimum set of functionalities and processes that are mandatory to utilize the new solution. The identification of the MVP allows to focus on the main functionalities, moving all fashionable or not mandatory requirements to a further stage that is going to start after the first solution release, and it is going to be performed once the laboratory team has an adequate experience to further assess the additional requirements/requests.
3) Software Development / Configuration
The changes identified in the previous step are going to be applied by the vendor, they are going to vary from simple configurations to complex customization. All the results coming from the development activities, should be provided in measurable and testable way so that an objective evaluation is viable and easy to perform.
The general development process should be identified together with the vendor to ensure a complete customer engagement, a fast increase in the software knowledge and a continuous process of feedback-review that helps in finding the best configuration of the LIMS solution to the real customer needs.
It is of vital importance that the software is adequately tested. The testing phase in not limited to meet some regulatory expectations, but it intends to verify every single functionality and their combination in order to ensure the meeting of the defined requirements for the execution of the laboratory activities.
The testing phase is the last opportunity to identify bugs, improvements or other changes, meaning that is essential to perform it with the highest attention. Usually improvements can be implemented after the system “go live”, but solving bugs or making changes while the system is in use, it’s far more complex than it is when it’s in the testing phase.
5) Going live with LIMS
The implementation of a new LIMS software is a significant change in a laboratory routine, and it requires an adequate planning. It is strongly recommended to plan in advance the right training activities and identify potential day 1 criticalities, including, but not limited to, the presence of master data into the system and the availability of the appropriate hardware (printers, barcode readers etc…). Additionally, the Hypercare period is usually planned in order to support the first utilization of the system, and receive immediate support in case of issues.
Although the LIMS implementation is an expensive and time-consuming activity, doing it for your laboratory is going to provide positive results. LIMS facilitates data management and regulatory compliance, providing the possibility to review and optimize your laboratories processes and make them more efficient.