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The Proprietary Software Validation Dilemma

When it comes to software validation, there is a presumption that home-grown software cannot be validated externally. Organizations tend to operate under the assumption that only those who develop and work with their proprietary software will have the ability to understand its core requirements and intended use.  As a result, the validation effort is directed internally, placing a burden on business users.

However, proprietary software is remarkably similar in functionality to off-the-shelf (OTS) or configurable off-the-shelf (COTS) software. The similarities afford an easy transition for an experienced validation professional. The differences encountered mainly occur in modularity and navigation.  These differences are a minor hurdle when a validation professional commits to partnering with a company. Experience with both commercial and proprietary software properly equips a validation professional to learn the software quickly.  The validation is just as thorough with the independent professional, and has many additional benefits that would not be achieved through an internal validation, to include 3rd party objectivity and industry best practices.
Posted By Colleen Kolba, Validation Analyst