Introduction

If your organization has made the strategic and financial commitments to implement a Laboratory Information Management System (LIMS) to better improve the quality and efficiency of your laboratories, then you should be aware of the impact of not properly preparing for this implementation by your organization could have. Implementing a LIMS is a huge undertaking and not being properly prepared could have drastic impacts on timeline, budget, scope, and user adoption of the system. This blog assumes you have already decided on the LIMS system you will be implementing, but before you allow the implementation vendor to come in and start the implementation, deciding on all the below points will set you up for implementation and user adoption success.

Team

Having an experienced team is the most important part of a successful implementation. Your team should consist of the people listed below. Keep in mind that some of the functions could be combined into one resource.

Implementation Team

• Project Manager (PM) – Your PM will keep your project on track for time, scope and budget and be the point person for overall communication to management. An experienced LIMS PM brings a wealth of knowledge to your implementation and is aware of the pitfalls that can lead to an unsuccessful implementation.
• Scientific Business Analyst (SBA) – A SBA that understands both LIMS and laboratory processes is one of the most valuable members of your team. Being able to translate your workflows into LIMS requirements and being able to push-back on the business for unnecessary configurations and customizations will ensure that your lab users get a system that truly meets the business’s needs.
• Change Management Lead – Having a person dedicated to user adoption of the new system is critical to success. This lead will plan out the activities and training needed for the business so that when your system is ready to go live, they are ready to use it and they will not be experiencing any surprises to their job.
• Master Data Lead – One of the most underestimated items in a LIMS implementation is the amount of master data that a company has. Master data is the data that needs to be in the system so that the end users can use the system as intended. This includes the tests they will be doing, the products and sample types they will be testing, and much more. Having a lead who is responsible for pulling together lists of all the master data that needs to be created and formulating a plan on how it will all get created and approved before go-live will ensure that the system is ready for use.
• SOP Lead – If your company works in a regulated environment, then having a lead who is responsible for identifying all the existing SOPs that need updating due to the new LIMS and deciding on new SOPs that will need to be created for the LIMS is a must. This lead will also be responsible for putting together a plan for who will be responsible for updating or creating the SOPs and when they will get done.
• Validation/Testing Lead – Having a lead responsible for all aspects of your validation or testing will ensure the system is ready for use. This person is responsible for all aspects including what documents need to be produced, what needs to be tested and the schedule that will be followed.
• Developers – If you decide to not use the LIMS vendor to implement the system, then having a development team with experience in your system of choice is valuable. They will be able to translate the requirements into what is needed in the system.

Subject Matter Experts (SMEs)

Dedicating business users to the team is important. They will serve roles throughout the implementation including LIMS Administrators, Super Users, and trainers and testing functionality for acceptance. You need to consider that this is adding work to their schedule, and you need to adjust for that. You cannot just expect that they will be able to fulfill both duties. They are needed on the team for things such as being in workshops to decide the future to-be workflows, answering questions, being in demos and the list goes on and on.

Management Team

Having management buy-in and involvement is crucial to the success of the implementation. At the very least you should have dedicated the below list to make sure that the implementation is always moving forward and to help resolve issues and conflicts that may arise.

• Project Sponsor – Has the overall responsibility of the project and is the first level to escalate issues to when they arise.
• Steering Committee – Meets at least monthly to be informed of the progress and help resolve any issues that the Project Sponsor has not resolved.

User Requirements and As-Is Workflows

Considering that you have already chosen your LIMS system, these should have been part of the vendor selection, but if they were not, now is the time to produce these. Use your SBA to produce detailed workflows of how you do every laboratory process today, that you expect to implement in the LIMS. From these workflows produce a set of user requirements for the LIMS. These requirements should be grouped by process and function and state if they are ‘Must Haves’ or ‘Nice to Have.’ This document will be used for generating your To-Be workflows and functional requirements during the implementation and will become the basis of your final user acceptance testing.

If you have multiple labs and/or sites doing the same workflows, generate these As-Is workflows and user requirements for each site. These can then be used as a basis for harmonizing your To-Be processes across the labs and sites during the requirements gathering phase of the implementation.

Implementation Plan

A best practice in LIMS implementations is to implement what has come to be known as the Minimum Viable (or Valuable) Product (MVP). This involves implementing the minimum amount of functionality to get your user base to start using and becoming familiar with the LIMS. The best part is that implementing the MVP increases user adoption of the system. Use the items below to produce an implementation plan that you will use to implement the MVP for your laboratory.

• Sites – How many sites will be using the LIMS. Consider staggering the go-lives for the sites to better understand the user adoption and to deal with any initial issues before moving on to the next site.
• Products – How many products are being created at each site. Consider using a pilot in which a smaller number of Products are initially captured in LIMS and have a plan to bring on the other Products.
• Tests – Similar to Products. Consider a pilot in which a subset of the tests you perform are initially captured in LIMS and have a plan to bring on the other Tests you perform.
• Workflows and Modules – Once your LIMS is fully implemented, what functionality will it have? From that, start with basic functionality to get your user base accustomed to using it and add additional workflows and modules over time.
• Timeline – What is your timeline and what is it based on? Be realistic on the timeline and what functionality can be implemented in that period using the budget you have allocated.
• SDLC – Waterfall, agile, a mix. Decide which way you will implement the LIMS.

Plans and Other Documents

With the above taken care of, the next recommendation is to get your plans in place and approved. Having these in place will allow you to know where you are going, how you will get there and how to deal with issues when they arise.

• Project Charter – The formal document that approves and project and describes the essential elements of it like, initial scope, team members, implementation plan (based on above section), budget, etc.
• Initial Project Plan – Based on the implementation plan. At this point, it should be high-level and updated at the end of the requirements gathering phase.
• Scope Change – A document that will deal with how requests to scope change and requirements changes will be handled after the initial approval of all functional requirements.
• Organizational Change Management – A plan on what activities and timelines for the end user base to get them trained and ready for the new system.
• Stakeholder – A plan on who the stakeholders are and how they will be involved. Most important for the SMEs chosen to work on the project.
• Communication – A plan of all communications that will be either socialized by email or in person through meetings. Includes frequency and purpose of the communications.
• Risk – A plan for how the implementation team will define risks and handle them if they emerge as issues.
• Testing/Validation – A plan to gather, create and test all master data for the implemented system.
• Master Data – A plan of all testing/validation deliverables and what the testing/validation workflow will look like.
• SOP – A plan to determine which SOPs need to be updated or created.

Infrastructure Needs

Based on the system you have selected, make sure you plan and procure everything from an infrastructure perspective. Everything from servers if you plan to host on premise, to space in the cloud to all user licenses that will be needed. Also look at hardware needs, everything from additional workstations in the laboratories, label printers that may be needed and networking connections in the laboratory for adding these workstations and instruments to your network. Don’t overlook things that may be needed such as bar code scanners and development environments of other software that you may be interfacing to the LIMS, such as your ERP or chromatography data system (CDS).

Summary

If you follow the above recommendations, the next steps in the implementation process, such as the functional requirements gathering, the builds and demos, handling scope changes and issues that arise will go much smoother.

To find out more about how Zifo can help with your LIMS implementation, please contact us at info@zifornd.com