Regardless of why you have decided you need a Laboratory Information Management System (LIMS), planning, selecting, and implementing a LIMS can be both a risky and a daunting task. Engaging a LIMS consultant or LIMS consulting group will mitigate your risk and increase your ability to attain true LIMS project success including attaining a high LIMS utilization rate. However, this will only be the case if you choose the right LIMS consultant. So what are the skills and skill sets you need to look for when choosing a LIMS consultant?
LIMS Consultant Required Skill Set: Domain Expertise
When selecting your LIMS consultant, it is critical that the consultant or consulting group has demonstrable experience and expertise in your specific industry and laboratory environment. In other words, if you are attempting to put a LIMS into a pharmaceutical Quality Control (QC) lab, the LIMS consultant you engage with should have experience and expertise in both working in a pharmaceutical QC lab and in implementing a LIMS in a pharmaceutical QC lab. Having experience and expertise in a pharmaceutical Research & Development (R&D) environment or a chemical QC lab is not sufficient. This degree of specificity may seem “over the top” but without real expertise in your domain, the LIMS consultant will not provide full value. They may not really understand the organization’s needs and requirements, the science going on, the laboratory work flows, nor the laboratory data and information flows.
LIMS Consultant Required Skill Set: LIMS Expertise
If you believe that when selecting a LIMS consultant that “all LIMS are the same” so as long as the consultant has some LIMS experience they will be fine, think again. While it can appear from a macro level that the capabilities and functions in every LIMS are the same, the reality is that once you get under the hood, how a particular LIMS is architected and how it implements capabilities will vary widely. Some questions that will highlight the differences between LIMS systems include:
- Is the LIMS you are seeking to implement a “tool kit” or a “shrink wrapped” system or something in between?
- How is tailoring of the system accomplished?
- If you need to integrate or customize the LIMS, how is this accomplished? Is there an API?
The answers to these questions and many others will depend on the particular LIMS you have selected. It is, therefore, critical that the LIMS consultant that you engage with has experience and expertise in the specific LIMS you are attempting to implement or enhance. Of course, if you are at the planning and selection stage of your LIMS project this requirement can be relaxed somewhat but the aforementioned Domain Expertise becomes even more critical.
LIMS Consultant Required Skill Set: IT Expertise
A LIMS is a software system that exists and resides within a network, on a server or servers (even if in the cloud), and interacts with the users on some type of UI device such as a laptop, tablet, or smartphone. Additionally, a LIMS will have a database which will need to be sized, installed, and tuned for optimum performance. So unless you have an IT staff that has experience and expertise with all these elements with respect to a LIMS, it will be critical that the LIMS consultant or consulting organization that you engage with has the IT expertise required to successfully install, implement and tune your laboratory informatics solution. Moreover, if the LIMS consultant also has IT expertise, you will reduce your resource needs accordingly.
LIMS Consultant Required Skill Set: Regulatory Expertise
Depending on your industry, you may or may not be subject to a variety of guidelines, rules, and regulations (FDA, 21CFR11, GxP, etc.) that will need to be addressed in your LIMS and its implementation. You may even be required to validate your LIMS. Some of the industries subject to regulations include Pharmaceutical, Food & Beverage, and Medical Device industries. The need to adhere to these regulations and the ability to prove that you do, will affect many aspects of your LIMS project including:
- Project tasks
- Project timelines
- Resource needs
- Documentation needs
LIMS Consultant Required Skill Set: Project Management Expertise
If you are planning on engaging a consultant to manage your LIMS project, then it is critical that you engage one with experience in planning and managing LIMS implementations. Having generic IT project management skills and experience is just not enough. Without LIMS project experience and expertise, your consultant will not be able to make accurate task effort estimates, resourcing needs assessments, nor manage the LIMS project team members and the communication needs of all the stakeholders. LIMS planning and implementation is a very complicated affair and just being PMP certified is not sufficient to guarantee success.
When you selected and implemented your LIMS, did you utilize a LIMS consultant or consulting group? If so, did you make sure that they had the skills described above? If they did not have the described expertise, was your LIMS project adversely affected?