Functionality requirements of a system should reflect your internal processes and capture the necessary data to effectively automate process steps. The following sections will provide an overview of the main functionality covered by laboratory information management systems.
Samples arriving to the lab for testing will require management. Samples are typically given a unique and sequential ID for traceability. This ID is then used through the lifecycle of the sample. Additional details of the sample may also be recorded as part of sample management such as time and date received, testing required, storage conditions, hazard information, expected turnaround times and current status.
Where testing provides a support function to a manufacturing process, it will be important for your system to have functionality for product and specification management. This function will allow you to pre-populate information about the product facilitating data entry for batch testing. Specifications should allow you to enter a description, target values, upper and lower limits, and upper and lower warning limits. Critical functionality will be decimal place reporting and rounding. The system should then use the pre-populated specification to check test results and provide a pass/fail conclusion.
Management of Test Methods should allow you to configure settings for inputs and outputs. Inputs are what you expect the analyst to enter, and outputs are what you would like the system to calculate. For example, if you have a test method that requires the average of two readings, you should be able to configure two inputs, and the output will hold an average calculation of those two inputs. Other settings you should look for are name, description, units, and validation limits. Validation limits check the user’s entry to ensure they haven’t entered silly numbers such as a pH of 18. Further examples of advanced test method management functionality would be to look at variable number of inputs and using calculated results as an input for a subsequent calculation.
How samples are processed may vary from lab to lab, or a lab may process different sample types differently. Having customisable workflows allows you to configure the system to work with your needs rather than changing the way you work to meet a system’s functionality. Workflow management is the ability to define the steps required to complete the analysis of a sample. For example, a lab may process both GMP and non-GMP samples. For GMP samples, the workflow may include an addition Validation step to independently check test results whereas this step may not be required for non-GMP samples.
Configuring user accounts should be essential functionality for any system. This is the core function that controls system access and permissions. The ability to create new user accounts and remove and/or lock user accounts will also give you the most flexibility in controlling access. Further functionality to support user management are Roles and Groups. Roles are user account settings which can be applied and managed across multiple user accounts to facilitate administration. Groups can segregate visibility to a set of user accounts.
The end document provided to a customer or a management meeting is important to get right and data displayed accurately. The reporting functionality in a LIMS should provide you with enough flexibility to customise the layout and contents. Advanced reporting functionality would allow you to create your own queries and format reports to meet your requirements.
A web client or sometimes referred to as web portal can provide a selected user base to access functionality of a LIMS through a web-browser. This allows full portability and access to data wherever you are so long as you have internet connection.
The functionality to integrate equipment improves automation and reduces the risk of transcription errors. The data transfer between your LIMS and equipment can occur through different means. In general, equipment will output data in a specific format. The key to integration is understanding that format and mapping the relevant data to the appropriate fields within your LIMS. Some LIMS companies may offer ‘Off-the-shelf’ solutions for commonly used equipment. Whereas other LIMS companies may complete equipment integration as a one-off bespoke development project. For either solution, be sure to understand the scalability of the solution and any on-going costs associated to maintain the integration.
From Enterprise Resource Planning to Invoicing, third-party software integration allows you to operate seamlessly with your LIMS. Similarly to equipment integration, data can be transferred between the two systems. In addition, it is common for bi-directional communication where your LIMS not only accepts data from other systems but sends data as well. Again, where LIMS companies do not have an ‘Off-the-shelf’ solution, they may approach these integrations as one-off bespoke requests.