"LIMS is just like buying an instrument or off-the-shelf software. All I have to do is plug it in, turn it on, and boom – I’m ready to process samples!”

Many LIMS solutions on the market today are considered “commercial-of-the-shelf” (COTS).  If you Google the term COTS you will get two very different definitions. 

Webopedia.com defines COTS as – Software that is commercially produced and ready to use without any form of modification by the user.

Wikipedia defines COTS as – Packaged software solutions which are then adapted to satisfy the needs of the purchasing organization, rather than the commissioning of custom-made, or bespoke, solutions.

While the Webopedia definition brings examples to mind like Microsoft Office.  LIMS solutions fall more appropriately under the Wikipedia definition of COTS.  Wikipedia goes on to explain: Although COTS products can be used out-of-the-box, in practice the COTS product must be configured to achieve the needs of the business and integrated to existing organizational systems.

LIMS is a dynamic and comprehensive Lab solution. While many LIMS solutions on the market today have very robust out-of-the-box capabilities and functionality, to truly get the most value out of LIMS and the highest return on your investment the LIMS should be configured to reflect the same processes and workflows of the laboratory.  To further increase efficiencies, the LIMS can be integrated with the Laboratory’s instruments and integrated with other software utilized by the business.

Laboratories differ greatly and industry needs, standards, and regulations vary greatly and can change over time. While some LIMS solutions are very industry specific, many of the big LIMS players offer LIMS solutions that are very versatile and will meet the needs of multiple types of Laboratories, industries, and regulations. Because these LIMS solutions are so flexible and versatile, they may require a little more configuration to meet the Laboratory’s specific needs. Industry specific LIMS solutions may require a little less configuration but they also allow less flexibility and the Lab may have to conform its processes and workflows to match the LIMS rather than the LIMS conforming to the Lab’s processes and workflows.   

To Avoid this LIMS Project Pitfall Ask these Questions:

  1. What are the out-of-the-box features and functionality of the LIMS?
  2. Is the LIMS configurable or does the core code have to be customized to make changes? Customization is not recommended because customized functionality is not supported by LIMS vendors and can also cause expensive issues when the LIMS is upgraded.
  3. What level of configuration is needed?
  4. What is the timeline for this configuration?
  5. Does the LIMS meet my industry needs as well the standards and regulatory requirements of my Lab? Examples include audit trail, e-signatures, 21 CFR Part 11 Compliance.

If in an FDA regulated industry, what validation services are provided by the vendor, and what is the responsibility of the Laboratory?   LIMS validations (IQ, OQ, PQ) are more complicated and on a much larger scale as compared to the validation of an instrument.

 What is the timeline for validation of the system? 


Don’t miss the next installment in our LIMS Project Pitfall series.

LIMS Project Pitfall #3: “My lab has a small number of users.  Our LIMS project budget would be way less than a large lab.”

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