Typical resourcing questions that arise when an organization embarks on a LIMS project include “What skill sets, how many resources, and what time commitment will be needed to guarantee success for our LIMS project?” First off, let me clearly state that there is no magic formula that will guarantee the success of your LIMS project. Besides the proper resources and resource levels there are many factors including planning, communication, and change management (to name a few) that are all critical to a LIMS project’s success.
That being said, depending on your environment (i.e. regulated vs. unregulated) and your organization’s experience level with laboratory informatics (total newbies vs. long term users), your chances of success will be greatly enhanced by properly staffing your LIMS project.
LIMS Project Resources – Who is Needed
In order to have a successful LIMS project there are a variety of roles that will need to be supported. These may or may not be full time positions during the LIMS project and some may continue on after the LIMS is up and running. These include:
- Executive Sponsor – This role is provided by a senior level person in your organization who while not actively involved in the day to day activities of the LIMS project, will have overall responsibility for the labs or organizations where the LIMS is to be implemented.
- Project Leader / Owner – This role is provided by a person who is directly responsible and accountable for the success of your LIMS project. (i.e. the person who gets the accolades or the reprimands)
- LIMS Project Manager – This role is provided by a person who develops and manages the LIMS project plan. They will also be responsible for managing resources and communications.
- LIMS Business Analyst – This role is provided by individuals who will analyze your laboratory and organization’s work flows, information flows, needs and requirements. They will also document all of this so it can be used to guide both your LIMS selection and implementation.
- LIMS Implementer / Programmer – This role is provided by individuals who will do the configuration and customization work on your LIMS.
- IT Technologist – This role is provided by individuals who will support the IT infrastructure for your LIMS including networks, hardware, software, etc.
- LIMS Super-User – This role is provided by individuals who will be the champions for your LIMS in the laboratory. One of them will often become your LIMS system administrator as well.
- LIMS Trainer – This role is provided by a person who will deliver your LIMS training. If customized training materials are needed, they may also do this.
- Change Management Facilitator – This role is provided by a person who will help manage the change in your laboratory and organization that usually accompanies the implementation of a LIMS.
- LIMS System Administrator – This role is provided by a person who will manage your LIMS for the organization.
- LIMS Team Members – These should consist of a cross section of the LIMS project stakeholders. They will include individuals from the lab, IT, management, QA, and any other appropriate areas that will be impacted by the LIMS.
- LIMS Validation Manager (if, regulated) – This role is provided by a person who will lead and coordinate your LIMSvalidation effort.
- LIMS Validation Experts (if regulated) – This role is provided by individuals who will develop and maintain your validation documentation including your validation plan, risk assessment, traceability matrix, etc. They will also develop your test scripts and execute them.
LIMS Project Resource Levels – How Many
Determining the number and time commitments for each role can be challenging. There are many factors that affect the number of resources that you will need to successfully implement your LIMS. The top two factors will be the size of your implementation and the speed with which you wish to have your LIMS up and running.
The larger the organization, number of departments, and number of sites, the larger your LIMS project team will become. Additionally, the shorter your LIMS implementation timeline is the more resources you will need to be successful. It is important to note that adding more resources will not necessarily allow you to compress your timeline. Many of the tasks can’t be done in parallel. So just “throwing more bodies at it” may not really help.
Other important resourcing considerations will be your environment (i.e. regulated or non-regulated), your LIMS experience level, and the degree of automation you wish to implement. Not all of the roles described above will require full time commitments for the duration of your LIMS project. It is recommended, however, that even part-time resources have the LIMS project designated as one of their top priorities.
Resourcing Your LIMS Project – Where do they Come From
So where are you going to get the resources to staff up your LIMS project? Obviously, the best source, although not always the easiest to secure, is within your own laboratory and organization. In fact, for several of the roles such as your Executive Sponsor and LIMS team members, this will be your only viable source. It is important that you firmly establish the time commitments for resources that get assigned to your LIMS project. It is not uncommon that these resources will still have their “day job” responsibilities.
The other great source for resources will be your LIMS vendor. It is very important that you establish a great working relationship with the provider of your LIMS. They will generally have very experienced resources and will have a vested interest in ensuring that your project is a success. After all, they will want to use you as a reference going forward.
Finally, you may want to engage with Subject Matter Experts (SMEs) and consultants when staffing your LIMS project. This is a great way to supplement your team and add expertise to your project. Make sure that any LIMS consultant you engage is independent (i.e. not in a vendor’s pocket), has expertise with implementing a LIMS in your type of laboratory, and has expertise in your particular LIMS. A truly independent LIMS consultant will have only your interests in mind and will be able to act as a trusted advisor for you. Also, they will have the time to accomplish their role without other distractions, unlike many internal resources.
Was your LIMS project adequately resourced? Tell us about it below in the comments.