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
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.
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.