Our previous blog on debunking LIMS and LIMS consulting myths proved to be a very popular blog. With that in mind, we have gathered here five more prevalent LIMS myths to be discussed. As before, while there may be a small kernel of truth to some of these, for the most part, these statements do not hold water. So, without further ado, let’s take a look at these LIMS myths and get to the busting!
For some time, there have been several LIMS solutions that have been offered for free (i.e. zero cost) by either an organization or a vendor/service provider. These offerings are often developed utilizing an Open Source philosophy or may have been developed by the offeror for their own lab’s use and now they are offering it for free to others. Yes, it’s true that these free LIMS do not have license fees or support fees associated with them, but are they truly “free”? Let’s see…
A “free LIMS” still needs to be planned, implemented, tailored, and perhaps even customized in order for it to utilized by your laboratory staff and its stakeholders. Your LIMS project will need a LIMS team and the personnel costs for the members (internal and external) will, therefore, be incurred by your organization. Remember, expecting your personnel to be on the LIMS team and do their standard 9 to 5 job is not really practical. Backfilling these resources, so they can be relieved of their standard workload and spend their time on the LIMS project, is an industry best practice.
Additionally, it is feasible that you will need additional IT infrastructure in order to fully utilize your new “free LIMS”. Yes, even if the “free LIMS” solution is a SaaS solution, you may still need peripheral devices such as printers, bar code printers and readers, or RFID tags and readers. You may even need to extend or strengthen your wireless network in the laboratories to assure connectivity to hand held devices (notepads, readers, etc.) that you wish to utilize to access the LIMS. If the “free LIMS” is not SaaS, then you may also need additional servers and/or disks.
Lastly, let’s look at support costs. Yes, it’s true that several “free LIMS” have very active user communities and very dedicated open source contributors that will help you at no charge should you run into problems with your “free LIMS”. But will your organization accept this level of risk? What is the potential cost and/or loss to the organization if your LIMS is down for an hour, a shift, a day? Oh, and someone needs to coordinate all these issues on your side. This is usually the LIMS Administrator who will need to dedicate a portion of their time to managing the LIMS or if you are a larger lab, a full time LIMS Administrator.
So, is a “Free LIMS” truly free? I would say that this myth is pretty busted!
Here’s a myth that we have run in to more frequently over the last 5 years or so. There is a segment of the scientific community that will assert that ELNs are “better” than LIMS. But what does “better” mean in this context? Are they saying that ELNs provide better capabilities for the recording, manipulation, management, and presentation of laboratory data and information? Or are they saying that ELNs are easier to use compared to LIMS? Or perhaps they are saying that ELNs are easier to implement and therefore better than a LIMS? If queried, they might say a bit of each or none of these reasons. Regardless, the reality is that while these assertions may be true in some circumstances, they are not universal truths. The reality is that it depends on many factors as to whether an ELN or LIMS will be better for your organization. And, it is not unusual that the best solution for you will be a combination of both LIMS/ELN.
One of the factors that can help determine if an ELN or LIMS will be the better solution is the type of lab that is seeking the solution. It can be argued that for R&D labs, especially the “R” side of the house, ELNs are better than LIMS for their needs. This generally comes from researchers’ belief that using a LIMS to manage their experiments and record their data, analyses, and observations would be too restrictive and would, therefore, squash their creativity and hamper innovation. ELNs, on the other hand, are viewed as more flexible and hence have the potential to promote creativity and innovation. However, it’s also true that while a LIMS can be implemented in such a way as to provide a very structured environment and stringent laboratory workflows, it can also be implemented to be as free-flowing and flexible as any ELN.
ELNs have been primarily implemented as “under glass” replacements for the paper lab notebook. As such, organizations have elected to remove the paper from their organization while providing researchers an unstructured environment in which to record their thoughts, lab data, and experimental information. Minimal effort was expended during these implementation processes to determine what meta data would be captured during an experiment or to develop standard dictionaries of terms, ontologies, taxonomies, or standards, or to develop information templates to provide structure to the notebook data. Yes, it was easy to put everything into your ELN but now you can’t get anything back out. You have created a Data Black Hole!
So, is ELN “better” than LIMS? I would say that this myth is pretty busted!
This is a myth that many people in a lab implementing a LIMS may believe especially if the company culture and project mandate are oriented toward eliminating any tailoring or customization of the LIMS so as to minimize project costs. The reality is, you can likely find a LIMS that will satisfy 80% of your needs and requirements as standard features and functions right out of the box within the solution. The remaining 20% of your needs cannot be satisfied by out of box functions and will require tailoring and customization. This may well take 80% of your LIMS project budget and time. How you go about satisfying the 20% will be the deciding factors in whether the lab’s processes and operations are disrupted or not.
Conventional LIMS implementation wisdom indicates that minimizing the customization of your LIMS is a best practice. However, we have seen this policy taken to the extreme to the detriment of the lab organization. In reality, a balance needs to be struck between the cost and risk of customizing your LIMS and maintaining your current processes, versus the cost and risk of potential disruptions to your operation changing your current laboratory processes and workflows to make use of standard LIMS functionality may cause. Also, remember that a best practice while implementing a LIMS is to standardize and optimize your laboratory and work processes so as to automate the most efficient processes and not just the same old way that things were done. Therefore, some changes to your lab processes are to be expected, extreme changes that would cause disruption is what must be balanced with the cost and time for customizing your LIMS.
So, will implementing a LIMS change our processes/disrupt the lab operation? I would say that this myth is pretty busted!
➞ Related Reading: Software Customization Configuration
This myth sounds like it was started by some really hopeful Regulatory Compliance people. Unfortunately, we run into this myth regularly and it’s easy to see where this belief could have been derived. LIMS were originally designed and implemented in quality assurance and quality control organizations in heavily regulated environments like pharmaceutical manufacturing. As such, a great deal of the functionality that LIMS offered were capabilities to aid in attaining and/or maintaining compliance with regulations that these operations needed to adhere to. But just because a software system has the ability to provide something, does not mean that it does so without any effort or cost.
For example, most modern COTS LIMS that are designed to support a pharmaceutical QC operation will have 21CFR11 capabilities available. This includes functions and features such as Audit Trails, E-signatures, Password encryption, Template (Sample Type, Analysis, etc.) Version Control, as well as modules like Stability and Dissolution testing. But these features and capabilities do not just spontaneously become activated and operational when you install the LIMS. In order to make use of these features and many others, you will have to implement them such that they satisfy your particular requirements while enabling you to attain and maintain compliance.
It is important to note that no LIMS on its own can assure regulatory compliance. Perhaps if your labs were fully automated with no human operators, this could be possible. But when you add humans to your laboratory environment, your regulatory compliance exposure increases dramatically. You will need Standard Operating Procedures (SOPS), formalized training, and periodic review/audit of your operations and the adherence to these policies.
So, does a LIMS solve all your regulatory concerns? Well, straight out of the box, this myth is clearly busted. However, a LIMS, if implemented properly, can help you attain and maintain regulatory compliance, but complete compliance depends on many human factors. So, LIMS alone is not the answer.
This myth is the classic “chicken and egg” scenario. “I have so much lab work that I need to increase efficiency and improve sample throughput but I don’t have time to implement a LIMS” will be the lament you most often hear. One of the largest benefits one can get from the proper implementation of a LIMS is the increase in efficiency and productivity its utilization can afford. Therefore, by implementing a LIMS, labs are able to process more samples and do more science with the same amount of lab resources. But it is also well known that implementing a LIMS takes time, effort and the right resources so you need to invest before you can reap the benefits.
So, is this myth true? Nope, it’s busted! It’s critical that your lab organization make the right investment in people, processes, and systems in order to be successful. Saying you are too busy to automate is like saying you are too busy to plan. We all know what that leads to…
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?