The Confusion Around COTS - A prudent LIMS buyer should require clear evidence that truly applicable business functionality is offered out-of-the-box. - BioPharm International

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The Confusion Around COTS
A prudent LIMS buyer should require clear evidence that truly applicable business functionality is offered out-of-the-box.


BioPharm International
Volume 19, Issue 9


Richard Wagner
In the software market for the biopharmaceutical industry these days, it seems that commercial off-the-shelf (COTS) applications are inescapable. Suddenly, everything is COTS. However, rapid proliferation of the term has far exceeded its actual availability. The terminology may have changed, but in most cases, the reality of system deployments has not. If a vendor claims to provide a COTS solution, what should a buyer expect? Better still, what should a buyer demand?

THE HISTORY OF LIMS AFFECTS US TODAY

To understand the current overuse, and in some cases blatant misuse, of the term COTS, a short recap of the laboratory information management system (LIMS) industry is in order. LIMS themselves did not originate in the pharmaceutical industry; they can trace their heritage to environmental laboratories. However, in serving one laboratory environment, vendors quickly realized that there were many similarities between laboratories in different industries, and aggressively marketed their systems to other sectors of business. To make the adoption of their solutions tenable in other industries, LIMS vendors worked to design highly adaptable systems, which was a logical approach. Customers were provided with a basic environment and database, and a set of tools with which to extend the system.

Building on Basic LIMS Platforms

At the time, most laboratories were completely paper-based, and their information management choices were restricted to two options: build something internally, or build something on top of a commercial LIMS platform. In many cases, the existing LIMS platform provided a good starting point, and could save the laboratory time and money compared with a completely customized solution.




In many cases, however, limitations imposed by a basic LIMS platform could actually prove to be complex or insurmountable barriers to a successful deployment, and custom solutions were not uncommon. The pharmaceutical industry saw many custom solutions developed due to the intense regulatory scrutiny and complex testing requirements of their day-to-day business.

The Trend Away from Internal Development

Commercial LIMS platforms continued to improve, however, and over the past 5–10 years it has become very uncommon for pharma companies to develop solutions internally, despite the fact that many significant gaps remain between the commercial, generic LIMS platforms and their specific business needs.


Quick Recap
In the past decade, pharmaceutical companies have increasingly recognized that software development is not their core competency. Executive management encouraged their IT teams to seek commercial solutions to fulfill their needs as much as possible, and actively discouraged internal development.

Customization and Configuration

LIMS vendors responded to this trend by claiming that their solutions no longer required "customization," but rather could now be "configured." This wordplay was, in many cases, nothing more than marketing. Pharma companies responded, knowing that customizing a LIMS system to suit their needs could represent greater effort than simply building one themselves, and hoping that this new "configurability" would reduce their deployment and maintenance burdens.

At this point, it is important to provide a clear definition of the difference between configuration and customization:

  • Configuration: A configuration option should require no programmatic code at all, and be completely tested by the vendor before software release. Ideally, configuration should be done through the user interface, although in some instances, configuration files may be used, provided that appropriate testing has been completed.
  • Customization: Customization is any form of programmatic code, including any and all varieties of SQL+Plus and Scripting.


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