10 Steps to Ensure a Successful LIMS Implementation

1. Understanding your requirements

It may seem obvious but the key to a successful project is to have a clear goal in mind. Setting the objectives of the new system helps you understand what the solution must do and what success will look like. Typical examples of laboratory goals include better regulatory compliance, data security (physical and access control), reduced transcription errors, improved reporting, and faster delivery of results. These objectives are a key part of the business case and can be used to sell the project to the budget holders.

It is important to identify any limitations of your current system but also understand what it does well. Increased productivity, through faster release of test results, automation of management reports, and higher sample throughput are all common goals used to justify a LIMS and focus management attention. However, don’t forget to think creatively about how LIMS can help your organization. Can you streamline instrument management by having an integrated calibration and maintenance system as part of the LIMS, or can you automatically check an analyst’s competency to carry out a procedure using a built-in competency management module. The outcome of gathering such requirements should be a User Requirements document. This can define the minimum viable product for the LIMS i.e., what the system must do, along with requirements that could bring additional or unexpected benefits.

Ensure the project team includes relevant input from all stakeholders. These may include laboratory users, QA representatives, the customers of the laboratory services, IT staff and others. Senior management must also be included to sponsor and champion the project. At this stage you’ll also need an idea of your budget and an outline approval to move ahead with the project; buy in from the management sponsor is key to this.

2. Evaluate to find the right LIMS for your needs

Once you have defined your requirements the next step is to research the market to discover suitable LIMS offerings. Compare what is available to your requirements, not forgetting non-functional requirements such as your preferences for an on-premise or cloud solution, how you want to pay for it (one off payment plus support or a regular [i.e., quarterly] charge). As you review the various LIMS solutions available in the market you will naturally find a sub-set of them that meet your needs and which you want to further investigate.

Make sure you regularly refer back to your list of minimum requirements to ensure you are not swayed by unimportant features, forgetting that the core product is not fit for purpose. Once you have a shortlist of two or three vendors you should evaluate their LIMS solutions in more detail:

1. Ask for a demo to explore the key features you need in your system (tell them those key features) but, during the demo, also spring a small task on them to see how they can configure their LIMS to suit your particular needs. (Nearly every lab requires some individual configuration. If this is hard for them to do it indicates the system may not be very flexible and may add unnecessary costs to the project).
2. Ask if you can do specific configuration for your lab yourselves, or if the vendor’s technical services team must be involved. If they do need to be involved ask about their experience and consider the cost.
3. Find out if the LIMS has a configuration environment. Some cloud solutions allow little or no adaption at all. Some, like Xybion LIMS, have a separate configuration environment. You may also need a test environment where configurations are formally tested before they are added to the live system. This is especially relevant for regulated environments.
4. Discuss and make sure you understand the pricing options including initial costs for licensing, implementation, training, and on-going annual support costs.
5. Look for references and review case studies from labs that use the LIMS.

Use your findings from this evaluation to select a supplier you feel confident in working with further.

4. Workshop to finalize you needs

It is good practice, and very common, to hold a Workshop on-site with all stakeholders and the selected supplier. This workshop typically goes through the user requirements (put together in step 1 and refined in step 2) ensuring that nothing is misunderstood or unclear. The outcome of the workshop is a Functional Specification document, provided by the LIMS vendor confirming the requirements, along with timescales and delivery phases (if there needs to be more than one). It is at this point that you may want to confirm the initial supplier selection you made as part of the evaluation process. However, if during the workshop it becomes evident that the selected supplier cannot meet your needs, look again at the short list of possible suppliers.

5. Implement the LIMS in phases

Once you have selected your supplier the implementation of the system can begin, but make sure you understand the approach that will be taken. Autoscribe implements LIMS solutions using agile methodology to adapt the closest out-of-the-box solution to the customer’s needs, according to the functional specification. This means that you can start familiarization immediately with the out-of-the-box solution and test each phased release as configuration continues. This ensures fast feedback from end users, minimizing misunderstanding and wasted time. Other suppliers, however, may take a big bang approach where they configure the system based on the written requirements and deliver the completed solution with minimal additional user input. In our experience this approach is less effective in ensuring a good fit to requirements.

7. Train Your laboratory personnel

General user training for the wider laboratory personnel is often performed by key users of the system, who will have already been trained by Autoscribe and have a detailed understanding of the LIMS. This allows staff to be trained by people who know best their standard operating procedures and lab terminology and can put their questions in context.

8. Software validation in regulated environments

For those systems used in highly regulated environments, such as pharmaceutical or medical device manufacturing, formal software verification and validation is required. Validation confirms that the LIMS fulfils its intended purpose using a risk-based validation plan.

10. Review, update and extend your LIMS

Having gone live you will want to re-assess if any of those “nice-to-have” features previously identified would be worth implementing in future phases. Automating more and reducing manual touch points often provide further areas of cost reduction and efficiency, offering additional savings and benefits to the organization. You should also continually review and update the LIMS as workflows, working practices, or the business in general changes. The LIMS must be capable of adapting to these changes.

You will also want to review the new software releases from the vendor. In Autoscribe’s case we release an update roughly every quarter. Each update can be installed without affecting the workflow or screens in a deployed system, making updates straight forward. Keeping your software up to date ensures you have all the latest security features built-in and the newest functional enhancements available to use.

One task that many organizations neglect is to review the benefits of the LIMS against the original business case. Doing this can help to prove the success of the project and provides evidence to support further expansion and investment in the solution. It can help answer the potentially embarrassing question, “What does the LIMS actually do for us?”.

Summary

The 10-step approach to successful implementation need not be complex or costly. Autoscribe’s fastest project to ‘Go-Live’ has been less than half-a-day using an out-of-the-box LIMS solution, though more typically timescales are six to twelve months. When thinking about LIMS implementation in your laboratory, don’t be put off by complex terminology, scare stories or worries about big bang implementations that deliver unusable systems. Instead, our overall recommendation is to make sure your project is controllable. Identify and make sure you know your key requirements (making sure they are based on business needs) and implement a flexible LIMS solution that meets those requirements. However, make sure you select a system that allows you to expand the LIMS to meet your future needs. Justification for this will be simpler once you have shown an initial return-on-investment and have the backing of both your users and management following a successful initial implementation.