The deployment of your LIMS should be scaled to meet your business needs. There are multiple factors to consider when collating your requirements for deployment such as resource, regulatory, security and cost.
Many LIMS providers will have a package to meet your requirements. The most important thing to remember is that the most successful deployments require time and dedication from your company. Keep in mind that a key success factor in any LIMS deployment is effective up-front planning, configuration and static data loading. Getting this right will be hugely beneficial when it comes to the routine use of LIMS in your day to day operations. The more time you dedicate to getting this right, the less hiccups you’ll have when it comes to routine use.
The most important part of any project is planning, whether it’s to deploy a LIMS or build the Empire State building (see our blog on this topic). As the saying goes - fail to prepare, prepare to fail. The key outputs from planning are User requirements, Risk assessment, and the Project Plan (or sometimes referred to as the Validation Plan in regulated industries).
A simple way to gather the user requirements is to process map your current process. By creating a visual representation of your current workflow, you’ll have the opportunity to identify key, value-added steps as well as non-value-added steps which are sometimes considered waste. From the process map, we can then elicit the requirements for automation or where you may require specific inputs to record data in the system.
Once you have gathered requirements, you will then have the foundations to build a risk assessment. For each requirement, think about the potential risks, what the impact would be if the risk occurred and the probability of the risk occurring. Once you understand each scenario, you’ll have the ability to score each risk and decide on the level of mitigating action you will put in place. Typically, the mitigating action is through computer systems testing or system validation to ensure that your required functionality will operate as you expect under these scenarios. Where the system may not have the functionality, you may consider implementing procedural and training controls to reduce the probability of that risk occurring.
Once you have understood the potential risks the system could have on your process, you will then be able to choose the level of deliverables required for the project. This would be documented in a Project Plan, or for those companies who operate in a regulated industry, this would be the Validation Plan. The Validation Plan outlines the approach and details the level of documented evidence that you will generate during the project to prove the chosen system is “fit for purpose” and meets your documented requirements. The Validation Plan may also outline roles and responsibilities to ensure expectations are met on both sides - client and supplier.
The chosen system will have a series of installation activities as advised by the supplier. This may include activities for which the supplier has sole responsibility or it may require your internal IT department to be an active player through the installation process.
Depending on the level of checks required for your project as outlined in the Validation Plan as a result of your risk assessment, you may have a series of checks to complete post installation. This could include version numbers, and initial configuration items created for the foundation of your system based on your requirements.
Once installation and installation check are complete, you would then begin verification activities. This would typically include a Test Plan which will outline the approach, management, and areas of testing required of the system. It will also document roles and responsibilities so that you have the appropriate team members available when executing testing activities.
Testing may be completed by executing a number of test cases which will include test steps. These steps will describe explicit actions for a tester to take in order to gather documented evidence that a traceable requirement has been met. Each step will have a pass or fail conclusion, and successful completion of these test case will allow the project to proceed to System Release. Where requirements or test steps have failed, having the supplier available to closely liaise with is beneficial in working through any issues efficiently and immediately.
Once all requirements are met, the testing has been deemed successful and complete, the system will then be made available for release. The release activities will include final Validation Reporting, summarising all of the project activities completed. It will also include user training and any further installations required within the operational environment.
You should also have an agreement signed and approved in place with your supplier which outlines the technical support process, on-going costs, service levels and expectations.