Validation Center™

This Standard Operating Procedure (SOP) establishes the development life-cycle that is used to guide design, procurement, configuration or customization, maintenance, and retirement of commercial off-the-self (COTS) software systems.  This SOP applies to all computer software applications that are purchased and enable the business’ functions irrespective of FDA validation requirements.  As used in this SOP, software applications does mean operating systems, network protocols, database management software, drivers, or other commercial software that by itself, does not support or enable a business or regulatory process.