The Premier
Laboratory Informatics Experts

How to Choose a LIMS Consultant

How to Choose a LIMS ConsultantRegardless 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

Watch Now - "CSV - More than Writing Test Scripts"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

Watch now - "Managing Multi-Sourced Lab Informatics Teams"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?

About Us - CSols, Inc.

CSols, Inc. – Laboratory Informatics Services Video

 

Top 5 LIMS and LIMS Consulting Myths – Busted!

Top 5 LIMS Myths LIMS Consultant MythsHaving been in the Laboratory Informatics and LIMS Consulting business for quite some time, we at CSols, Inc. have been exposed to many myths and misconceptions.  While there may be a small kernel of truth to some of these, for the most part these statements do not hold water.  In fact, some of them malign both LIMS and LIMS consultants so we thought it would be a good idea to list out the top five myths and truly “Bust” them.

#1 – All LIMS are the same

While at the highest level this may appear to be true, the reality is that LIMS systems are very different.  Firstly, let’s look at “purpose-built” LIMS.  LIMS that are designed to support different types of labs will differ in feature sets, workflow, and data flow.  For example, a LIMS that is purpose-built to support a contract environmental testing lab will be dramatically different than one that was purpose-built to support a forensics lab.  Another major difference can be seen in LIMS that are designed to support research organizations versus those that are designed to support QA/QC.  This will be most evident in the architecture of the system, namely the ability to easily and cleanly support projects as opposed to samples.

Looking at “general” LIMS, functionality differences may not be pronounced but the differences are there, below the surface.  In these systems, it is not what the LIMS provides but how the LIMS is architected and how the functionality is implemented.  This generally comes down to the degree of configurability versus customization (aka programming) needed to implement the LIMS.

At the extremes are the “toolkit” LIMS where virtually all functionality is implemented by programming and the “configuration only” LIMS where all functionality is implemented via drop downs, radio buttons, filling in forms, etc. all without any programming.

Download Strategic Services Literature: 5 Tips for Choosing the Right Informatics Solution

#2 – The LIMS Consultant knows which LIMS is “The Best LIMS” but they just won’t tell us

One of the things we get asked all the time is “Which LIMS is the Best LIMS?”  This is usually followed by waggling eyebrows, winks, and nudges by the questioner as they assume that we really know but just won’t tell them. We have even had some people try the Barbara Walters “off the record” approach to get an answer.  Believe me, if we knew the answer to this question we would tell you and we would also make sure that we know how to implement, customize, integrate and validate that LIMS and only that LIMS.  This would save us a ton of training time and allow us to laser focus our informatics consultants’ skill sets.

The real answer to this question is that it really depends on the needs of your lab and organization, your infrastructure, your internal resource availability and much more!  All LIMS have strengths and weaknesses, so based on your particular situation there will be a LIMS that best suits your lab and organization now and into the future.  So it is not that we are trying to squeeze money out of you by providing you with LIMS Planning and Selection Services just to eventually tell you the answer.  It’s truly necessary to go through these exercises to determine the LIMS that is the best fit for you.

→ Related Reading: Who are the Top LIMS Vendors?

#3 – LIMS implementation is quick and easy

This is a myth that many in the informatics industry and their customers really wished were true.  We have seen time and again, promises of rapid, simple implementation of a LIMS by vendors or consulting organizations.  We have even seen some LIMS that claim to require no implementation at all, just login and you are good to go.  Unfortunately, these promises and claims are not true.

Implementing a LIMS successfully is hard and it generally takes a considerable amount of time, effort, resources and money to accomplish.  The amount of time required will be dependent on many factors including:

  • Size of the implementation – number and types of labs, locations, etc.
  • Resource availability – lab, IT, SMEs, etc.
  • Integration requirements – systems, instruments, etc.
  • Culture – languages, change tolerance, etc.

It is important to point out that the key word in the previous paragraph is successfully because while it is possible to implement a LIMS quickly and easily, that implementation will most likely be a failure.  Success, in this context, is defined as implementing the LIMS on-time, within budget, while meeting all requirements, and being fully adopted and utilized by the users and organization.  Some of the time angst can be addressed by utilizing a Phased Approach to your LIMS implementation, although this will not necessarily affect your overall timeline.  (See “Big Bang” vs. “Phased Approach”)

Interestingly, the ancillary myth to this is “Planning your LIMS implementation project is a waste of time.”  In fact, one of the keys to success in LIMS implementation is taking the time to fully understand and document your requirements, workflows and processes, data and information flows, infrastructure, resources, etc.  Using this information to plan your LIMS implementation and then managing to that plan has been shown to greatly enhance LIMS project success rates while greatly enhancing adoption and utilization rates.

→ Related Reading: LIMS Implementation Misconceptions

#4 – If the lab implements a LIMS and gets automated, I will lose my job

This myth was started in the early days of LIMS when systems were being justified based on how many Full Time Equivalents (FTEs) of time could be saved through the automation of the lab and the lab operation.  The fear was that the time saved by automating reports, calculations, results reviews, work processes, etc. would enable management to cut the manpower levels in the lab, thereby, saving money.

In reality, by automating the laboratory and its processes, workflows, and data acquisition and analysis, the efficiency gains allowed the laboratory staff to devote more time to doing more and better science, increasing innovation and sample throughput.  Cutting staff was rarely, if ever, the end result.

→ Related Reading: 10 Ways LIMS Can Automate Your Lab

#5 – LIMS consultants just want to stretch out the LIMS project to make more money

Any consultant or consulting organization hears this myth over and over again.  However, this is actually completely opposite to the goals of any good consultant or consulting organization.  What we really want to do is finish the LIMS project early while exceeding the expectations of our clients and delivering the highest quality work.  In this way we delight our customers and they will come back to us with more and more projects.  It is important to remember that the LIMS and laboratory informatics world is a pretty small universe and a consultant’s or consulting organization’s reputation is of paramount importance to maintaining a successful and growing business.  People and organizations that have, or are contemplating, putting in place laboratory informatics strategies and solutions will invariably know each other and if a consultant or consulting organization tries to play this game, they will quickly be found out and panned.

→ Related Reading: Why did my LIMS Implementation Fail?


Have you heard these myths before?  Did you believe them then and do you believe them now?  What other myths with regards to LIMS and/or LIMS Consulting have you heard?

Watch Webinar: "LIMS Myths and Legends - Busted!"

Acquiring an Informatics System: Where do Consultants Fit In?

Why Projects Fail: Human Shortcomings

Figure 1. Some of the common human factor failure points that knowledgeable consultants can help correct.

For the modern laboratory, an informatics system to manage samples and data has become almost a necessity.  Whether a Laboratory Information Management System1 (LIMS) or an Electronic Laboratory Notebook2 (ELN), very few laboratories can effectively operate without them.  This is especially true in highly regulated industries.  However, the process involved in planning and selecting an informatics system can be very involved and fraught with risk.  The degree of risk is significant, with The Standish Group3 estimating that 61% of all IT projects fail.  Though some disagree with The Standish Group’s methodology4, by their estimate only 39% of projects are fully successful.  These failures are frequently due to human factor issues rather than technical ones5.  The good news is this failure risk can be minimized by a conscientious risk management process6 and the counsel of an Informatics Consultancy.

The process for planning and acquiring an informatics system is summarized in the graphic below.  It is easy to get the impression from this graphic that this is a very straightforward and simple process, but in reality it can be a very complex time and personnel intensive process7.  Hiding behind this diagram are many concurrent processes and contingent steps that must be performed while simultaneously managing project time and cost.

General steps in selecting a laboratory informatics system.

A consultancy will help your organization avoid the cost of false starts by helping structure and plan your project.  This can include helping to develop realistic goals for the project.  Additionally, members of a consultancy have widely diverse backgrounds and expertise and will have worked in all types of laboratories, making them ideally suited to thinking outside of the box when applying best practices.  Specific project aspects where a consultant’s assistance can prove invaluable include:

  • Analyzing current laboratory processes and identifying ways to optimize workflows by leveraging informatics solutions, eliminating unnecessary steps
  • Identifying system needs, i.e. LIMS or ELN
  • Generating list of potential system vendors
  • Writing the Request For Proposal (RFP)
  • Reviewing returned proposals and vendor selection.
  • Acting as interpreter between the laboratory and their IT group and vendor, as they speak a different language than the laboratory
  • Defusing political issues within the laboratory and any supervisory organizations
  • Training laboratory personnel to use their new laboratory informatics system in the context of their actual processes

With today’s lean organizations, a frequently overlooked detail impacting project success is who will be performing all of this work?  It is usually the most computer savvy analyst within the laboratory who is ‘elected’ to herd this process along.  While bringing someone over from the IT group is another option, it too is generally challenging as laboratory processes are not their specialty. In most cases the person selected will have no experience in laboratory informatics and automation.  Additionally, this person may still be expected to perform their usual job as well, quickly leading to burnout.  The minimal experience and scarcity of personnel resources makes it difficult to generate a complete requirements list, let alone to write a RFP or evaluate the submitted proposals.  Concurrently, they may be tasked with the political problem of acquiring buy-in and cooperation for the project, lack of which can kill an implementation project before it starts.  Even when you are lucky enough to have an informatics specialist on staff, they do not have sufficient time to do it all and the resources of a consultancy can help fill the gap.

The diverse background of people working within a consultancy means that it is less likely that anything will be missed during the requirements gathering phase of the project.  Having generated multiple RFPs, a consultancy is also in an excellent position to help you convert your list of requirements into a meaningful RFP, as they would have the expertise to know what needs to be included and what can be left out.  An effective approach to this would be to leverage a Risk Based Requirements (RBR)8 methodology.  This methodology focuses approximately 80% of your overall effort on the 20% of the functionality that is unique to your operation. This is important, as it is these requirements which are most likely to be missing from an off-the-shelf system, therefore, requiring customization. When it comes time to evaluate all of the submitted proposals and vendor demonstrations, a consultancy can assist you to separate what some vendors might imply from what they will actually do. Their expertise helps you avoid demonstration “magic tricks” that can easily fool you with your own assumptions. This will prevent the surprise of having to buy additional modules or contract custom coding to obtain the functionality you thought you’d already purchased!

In the final balance, the selection of the system to acquire will be yours, but consultants can help take some of the mystery and frustration out of the process.  For added value, make this process a learning experience by having your people work closely with the consultants.  It is not uncommon for organizations to be reluctant to add the additional expense of a consultancy to what is usually already a tight budget. However, in this case the investment can actually reduce the overall cost of the project, minimize delays, and, in many instances, make the difference between a successful and a failed implementation.

Whatever your situation, the challenge of a laboratory informatics project is not to be undertaken lightly; it’s something you’ll want to get right, the first time. The guidance from a consultancy will dramatically increase your chances of arriving in the 39% group of fully successful IT projects.

References

  1. Laboratory information management system. LIMSWiki (2013). at <http://limswiki.org/index.php/Laboratory_information_management_system>
  2. Electronic laboratory notebook. LIMSWiki (2013). at <http://limswiki.org/index.php/Electronic_laboratory_notebook>
  3. The Standish Group International. CHAOS Manifesto 2013: Think Big, Act Small. (2013). at <http://versionone.com/assets/img/files/ChaosManifesto2013.pdf>
  4. Eveleens, J. L. & Verhoef, C. The rise and fall of the Chaos report figures. IEEE Softw. 27, 30–36 (2010).
  5. Collier, C. LIMS comes of age – information management for every laboratory. Lab. News (2007). at <http://www.labnews.co.uk/features/lims-comes-of-age-information-management-for-every-laboratory/>
  6. McDowall, R. D. Risk Management for Laboratory Automation Projects. J. Assoc. Lab. Autom. 9, 72–86 (2004).
  7. Devorick, W. Batteries Not Included; Looking Beyond the Informatics Quote. at <https://csolsinc.webex.com/csolsinc/ldr.php?AT=pb&SP=MC&rID=25760297&rKey=08c26f4c4604d090>
  8. Turnbull, G. Apples to Apples – Selecting the Right Informatics Solution. (2013). at <https://csolsinc.webex.com/csolsinc/ldr.php?AT=pb&SP=MC&rID=26907407&rKey=643fd2f6600f37a2>

Please provide the following information for verification purposes only. Your information will not be shared.

Name
E-mail
Company
Phone