How to purchase COTS software

• By: David Nettleton , FDA Compliance Specialist, Computer System Validation.
• Date: January 06, 2010

Software has become part of almost every business process and the scope and complexity of software is increasing every year. Most software is purchased from a vendor and is referred to as commercial off-the-shelf software (COTS). The term “developer” identifies people that create software and for the purposes of this article is equivalent to the vendor. The term “user” identifies people that use software to perform their job.

The developer and users share responsibilities that affect the quality of the software. The developer must create the software to contain the functionality required by the users, and perform developer validation. The users must perform user validation of the software in the context of its application, meaning the business processes that use the software.  Additionally, the user must ensure proper maintenance and control of the software on an ongoing basis.

The requirements of validation from the developer and user perspectives have many steps in common but the focus of each step is different because their perspectives are different.