One of our past blogs entitled “Top 5 LIMS and LIMS Consulting Myths – Busted!” was met with great enthusiasm. Interestingly, several of the comments on this blog pointed out other LIMS myths and misconceptions. After reviewing these and taking stock with several of my fellow lab informatics aficionados, we have decided to revisit this topic and present here several more LIMS myths that deserve public busting. Remember, while there may be a small kernel of truth to some of these, for the most part, these statements do not hold water.
We at CSols have heard this statement many, many times. Often it’s made just prior to the potential client asking one of our consultants to “just tell me which LIMS is the best”. Unfortunately, as we have pointed out innumerable times, there is no single best LIMS. The LIMS that is right for you is dependent on your needs and requirements and the only way to really select the best LIMS for your organization is to go through a well-established and documented LIMS selection process. Critical to your LIMS selection project success will be how thoroughly you conduct your needs assessment and perform you workflow analyses and optimization processes. Yes, this will take time and effort but you will be paid back many times over, as you proceed with your LIMS implementation project.
Many of the steps taken during the course of your LIMS selection project will be leveraged down the road during the implementation of your chosen LIMS solution. For example, one of the best ways to tease out an organization’s needs and requirements, which are critical to establish when choosing your LIMS, is to perform workflow analyses and optimization endeavors. However, the same workflow analyses and optimization endeavors should be done prior to implementing your LIMS to ensure you are automating the most efficient processes. So while the time and effort you expend during the selection process to do this is not trivial, you will save that same time and effort later, during the LIMS implementation.
We also hear “I didn’t have time to do a formal LIMS Selection” after the fact, by panicked LIMS project leaders who are lamenting the fact that while they saved a bunch of time, effort and expense, they now have a LIMS that is not right for them. Sadly these LIMS project leaders are usually facing a huge time, resource, and budgetary mess and even their own position with their company may be in jeopardy.
This is a classic LIMS myth that while fabulous if it were true, is unfortunately not. Whether the derivation of this myth comes from wishful thinking or overzealous LIMS marketers, the fact is that while a LIMS can HELP you be regulatory compliant, just installing one will not. The devil is in the details. How you choose to implement your LIMS and what features and functions you elect to use and in what manner, will all have a huge effect on whether your LIMS will truly help make your lab operation regulatory compliant. But even if you take advantage of every regulatory feature of a LIMS, there will still be aspects of your compliancy that cannot be addressed within a LIMS. This is quite normal and we are often called upon to help clients use SOPs and other documentation techniques to help attain and maintain regulatory compliancy.
Another aspect of regulatory compliancy for certain industries is the requirement to validate your scientific software (i.e. LIMS). Computer System Validation (CSV) is a very well documented process with clear deliverables that will require effort, time, and resources to accomplish. A LIMS, generally speaking, is not provided in a pre-validated state. Therefore, you would still need to validate the solution and provide all the documentation needed to withstand an audit.
When developing and documenting your LIMS user requirements, it is typical to prioritize them in order to determine what is most important to you and what should be implemented in phase one of your LIMS implementation project. One of the classic ways of doing this is by using the “MoSCoW” method which stands for “Must Haves”, “Should Haves”, “Could Haves” (aka “Nice to Haves”), and “Won’t Haves”. Although interfacing lab instruments to your LIMS yields many benefits including: higher quality results, data integrity support, efficiency gains, and high user satisfaction and adoption rates, most lab organizations don’t designate them as “Must Haves”, worthy of inclusion in the first phase of implementation. Rather, they are relegated to the “Nice to Haves” and put off to Phase 2 or beyond of the LIMS implementation project.
Oddly enough, it is common to use the efficiency gains and associated cost savings that interfacing instruments to LIMS yields as a major component of justifying your LIMS, even though those interfaces may never really get implemented. You see, getting to Phase 2 of your LIMS project where implementing the instrument interfaces have been planned for, can be a real challenge. In fact, Phase 2 often never materializes.
Perhaps the origin of this myth was the excitement and thrill from the time period when Electronic Lab Notebooks (ELNs) first became truly viable in the commercial lab informatics market. It would be natural that a new, shiny technology (ELN) would be heralded as the demise of an older, more established technology (LIMS). There would have been many parties that had a vested interest in having ELNs supplant LIMS. But as the saying goes, “The rumors of my demise have been greatly exaggerated!” would apply here.
Both LIMS and ELNs are viable lab informatics solutions that can be used in the same types of labs and industries. In fact, LIMS and ELNs have, over time, become truly complementary solutions and are often implemented simultaneously and in an integrated fashion.
Have you heard these myths before? Did you believe them then and do you believe them now? What other myths with regards to LIMS have you heard