Development methodologies for computerized systems have been evolved and grown mature in the past decades. Modern, tool-supported approaches are employed in order to determine how IT can sufficiently contribute to create business value and facilitate processes. Already in the late nineties, scenario-based specification and documentation approaches have been presented as a way to go and a vehicle to foster a common-denominator-based discussion ground for stakeholders with various backgrounds.

While software vendors delivering commercial-off-the shelf products to the pharmaceutical industry very often use an agile, scenario-based paradigm for their product development lifecycle it is not too much seen employed in the pharmaceutical industry itself. Validation documentation frameworks very often reflect a traditional way of specification and development still using for instance iconized and numbered user requirements specifications in order to describe the desired system behavior and operational parameters. And even if an agile approach is used to specify a bespoke or more likely: configurable computerized system the results are very often translated into the old way of thinking and documentation once determined. The question arises how the output of an agile approach can seamlessly be carried all the way through a validation framework and what implications and challenges one would face if pursuing such a way.

With the use of examples, this presentation would like to reflect on the described constellation and shed light on such documentation implications during selected steps of the validation framework.